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&NA;. "Hib vaccine/meningococcal vaccine." Reactions Weekly &NA;, no. 1284 (January 2010): 27. http://dx.doi.org/10.2165/00128415-201012840-00089.
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WENDLING, PATRICE. "Hib/Meningococcal Combo Effective in Infants." Family Practice News 37, no. 12 (June 2007): 21. http://dx.doi.org/10.1016/s0300-7073(07)70734-x.
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WENDLING, PATRICE. "Hib/Meningococcal Combo Vaccine Effective in Infants." Pediatric News 41, no. 6 (June 2007): 1–6. http://dx.doi.org/10.1016/s0031-398x(07)70351-x.
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Miller, Jacqueline M., Narcisa Mesaros, Marie Van Der Wielen, and Yaela Baine. "Conjugate Meningococcal Vaccines Development: GSK Biologicals Experience." Advances in Preventive Medicine 2011 (2011): 1–17. http://dx.doi.org/10.4061/2011/846756.
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Meningococcal diseases are serious threats to global health, and new vaccines specifically tailored to meet the age-related needs of various geographical areas are required. This paper focuses on the meningococcal conjugate vaccines developed by GSK Biologicals. Two combined conjugate vaccines were developed to help protect infants and young children in countries where the incidence of meningococcal serogroup C or serogroup C and Y disease is important: Hib-MenC-TT vaccine, which offers protection againstHaemophilus influenzaetype b andNeisseria meningitidisserogroup C diseases, is approved in several countries; and Hib-MenCY-TT vaccine, which addsN. meningitidisserogroup Y antigen, is currently in the final stages of development. Additionally, a tetravalent conjugate vaccine (MenACWY-TT) designed to help protect against four meningococcal serogroups is presently being evaluated for global use in all age groups. All of these vaccines were shown to be highly immunogenic and to have clinically acceptable safety profiles.
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Borrow, Ray, Nick Andrews, Helen Findlow, Pauline Waight, Joanna Southern, Annette Crowley-Luke, Lorraine Stapley, Anna England, Jamie Findlow, and Elizabeth Miller. "Kinetics of Antibody Persistence following Administration of a Combination Meningococcal Serogroup C and Haemophilus influenzae Type b Conjugate Vaccine in Healthy Infants in the United Kingdom Primed with a Monovalent Meningococcal Serogroup C Vaccine." Clinical and Vaccine Immunology 17, no. 1 (November 11, 2009): 154–59. http://dx.doi.org/10.1128/cvi.00384-09.
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ABSTRACT The kinetics of antibody persistence following the administration of a combination meningococcal serogroup C and Haemophilus influenzae type b (Hib) conjugate vaccine (Menitorix) in the second year of life in children primed with two doses of one of three monovalent meningococcal serogroup C (MCC) vaccines was investigated. The study subjects were administered either Menitorix at 12 to 15 months of age, followed by the seven-valent pneumococcal conjugate vaccine (PCV7) and the measles, mumps, and rubella vaccine 4 to 6 weeks later, or all three vaccines concomitantly at 12 to 15 months of age. Blood samples were collected before and 1, 2, 12, and 24 months after the boosting. Sera were analyzed for meningococcal serogroup C serum bactericidal antibody (SBA) and IgG as well as Hib-polyribosylribitol phosphate (PRP)-specific IgG. The antibody persistence data from this study were compared to those of a prior study of Southern et al. (Clin. Vaccine Immunol. 14:1328-1333, 2007) in which children were given three primary doses of a vaccine containing both the MCC and the Hib vaccines but were boosted only with a Hib conjugate vaccine. The magnitude of the meningococcal SBA geometric mean titer was higher for those subjects primed with the MCC vaccine conjugated to tetanus toxoid (NeisVac-C) than for those primed with one of two MCC vaccines conjugated to CRM197 (Menjugate or Meningitec) up to 1 year following boosting. Two years after boosting, the percentages of subjects with putatively protective SBA titers of ≥8 for children primed with NeisVac-C, Menjugate, and Meningitec were 43%, 22%, and 23%, respectively. Additional booster doses of the MCC vaccine may be required in the future to maintain good antibody levels; however, there is no immediate need for a booster during adolescence, as mathematical modeling has shown that persisting herd immunity is likely to control disease for a number of years.
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Schmitt, Heinz-J., Gudrun Maechler, Pirmin Habermehl, Markus Knuf, Roland Saenger, Norman Begg, and Dominique Boutriau. "Immunogenicity, Reactogenicity, and Immune Memory after Primary Vaccination with a Novel Haemophilus influenzae-Neisseria meningitidis Serogroup C Conjugate Vaccine." Clinical and Vaccine Immunology 14, no. 4 (February 7, 2007): 426–34. http://dx.doi.org/10.1128/cvi.00377-06.
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ABSTRACT We evaluated two formulations of a new combined Haemophilus influenzae type b (Hib)-meningococcal serogroup C (MenC)-tetanus toxoid (TT) conjugated vaccine and two formulations of a new MenC-TT vaccine (trials 711202/001 and 711202/008; clinical trial register numbers NCT00135486 and NCT00135564 [www.ClinicalTrials.gov ]). A total of 520 healthy infants were randomized to receive primary vaccination (at 2, 3, and 4 months) with either MenC-TT plus diphtheria-tetanus-acellular pertussis (DTPa)-hepatitis B virus (HBV)-inactivated poliovirus (IPV)/Hib, Hib-MenC-TT plus DTPa-HBV-IPV, or MenC-CRM197 plus DTPa-HBV-IPV/Hib (control). At 12 to 15 months, subjects received a polysaccharide challenge with meningococcal polysaccharide C plus a DTPa-HBV-IPV/Hib booster. Immune responses were assessed 1 month after dose 2, 1 month after dose 3, and prior to and 1 month after the booster. After primary vaccination, there was no difference between groups in seroprotection rates as measured by titers of serum bactericidal antibody (SBA) to MenC (≥1:8) or concentrations of anti-polyribosyl ribitol phosphate (PRP) antibody (≥0.15 μg/ml). Prior to the booster, there was no difference between groups in SBA seroprotection rates, whereas anti-PRP seroprotection rates were significantly higher after priming with Hib-MenC-TT. Booster doses induced large increases in SBA and anti-PRP antibodies in primed groups, indicating successful priming with induction of immune memory. Reactogenicity and safety were similar in all groups during the primary and booster phases. A novel combined Hib-MenC-TT conjugate vaccine induced MenC and Hib responses comparable to those induced by licensed monovalent vaccines. A Hib-MenC-TT conjugate vaccine provides vaccination against two major pathogens in a single injection and is a suitable candidate for use in primary or booster vaccination schedules.
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de Voer, Richarda M., Rutger M. Schepp, Florens G. A. Versteegh, Fiona R. M. van der Klis, and Guy A. M. Berbers. "Simultaneous Detection of Haemophilus influenzae Type b Polysaccharide-Specific Antibodies and Neisseria meningitidis Serogroup A, C, Y, and W-135 Polysaccharide-Specific Antibodies in a Fluorescent-Bead-Based Multiplex Immunoassay." Clinical and Vaccine Immunology 16, no. 3 (January 7, 2009): 433–36. http://dx.doi.org/10.1128/cvi.00364-08.
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ABSTRACT We expanded the meningococcal serogroup A, C, Y, and W-135 multiplex immunoassay (MIA) to simultaneously detect immunoglobulin type G antibodies directed toward Haemophilus influenzae type b polysaccharide (HibPS). The monoplex HibPS assay was compared to a HibPS-specific competitive enzyme-linked immunosorbent assay and showed a good correlation (R = 0.96). Furthermore, no cross-reactivity between HibPS and the four meningococcal serogroups was detected. This pentaplex meningococcal Hib MIA is a useful tool to investigate serological responses toward different childhood PS vaccines.
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&NA;. "Hib meningococcal groups C and Y conjugate vaccine promising." Inpharma Weekly &NA;, no. 1588 (May 2007): 7. http://dx.doi.org/10.2165/00128413-200715880-00015.
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Moss, S. J., A. C. Fenton, J. Toomey, A. Grainger, R. Borrow, P. Balmer, J. Smith, and A. R. Gennery. "Immunogenicity of a Heptavalent Conjugate Pneumococcal Vaccine Administered Concurrently with a Combination Diphtheria, Tetanus, Five-Component Acellular Pertussis, Inactivated Polio, and Haemophilus influenzae Type b Vaccine and a Meningococcal Group C Conjugate Vaccine at 2, 3, and 4 Months of Age." Clinical and Vaccine Immunology 17, no. 3 (December 30, 2009): 311–16. http://dx.doi.org/10.1128/cvi.00315-09.
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ABSTRACT The immunogenicities of conjugate pneumococcal vaccines have been demonstrated when they are administered at 2, 3, and 4 months of age. There is a paucity of data on the immunogenicity of this vaccine when it is administered concurrently with other vaccines in the primary immunization schedule of the United Kingdom. We immunized 55 term infants at 2, 3, and 4 months of age with the seven-valent pneumococcal conjugate vaccine (PCV7), the meningococcal group C conjugate (MCC) vaccine, and the diphtheria, tetanus, five-component acellular pertussis, inactivated polio, and Haemophilus influenzae type b (DTaP5/IPV/Hib-TT) vaccine. The immune responses to the H. influenzae type b (Hib), MCC, and tetanus vaccines were measured at 2, 5, and 12 months of age; and the immune responses to PCV7 were measured at 2 and 5 months and then either at 12 months or following a 4th dose of PCV7. There were increases in the geometric mean concentrations (GMCs) of all antigens postimmunization. Greater than or equal to 90% of the infants achieved putatively protective levels postimmunization for all vaccine antigens except pneumococcal serotype 6B and Hib. The GMCs of the PCV7 serotypes increased following a 4th dose, although one infant had not reached putative levels of protection against serotype 6B. In conclusion, when infants were vaccinated according to the schedule described above, they had lower postprimary immunization responses to Hib, meningococcus group C capsular polysaccharide, and pneumococcal serotype 6B than the responses demonstrated by use of the other schedules. Despite this finding, there was a good response following a 4th dose of PCV7.
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Noya, Francisco, Deirdre McCormack, Donna L. Reynolds, Dion Neame, and Philipp Oster. "Safety and Immunogenicity of Two Doses of Quadrivalent Meningococcal Conjugate Vaccine or One Dose of Meningococcal Group C Conjugate Vaccine, both Administered Concomitantly with Routine Immunization to 12- to 18-Month-Old Children." Canadian Journal of Infectious Diseases and Medical Microbiology 25, no. 4 (2014): 211–16. http://dx.doi.org/10.1155/2014/237560.
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OBJECTIVES:To describe the immunogenicity and safety of a two-dose series of a quadrivalent meningococcal (serogroups A, C, Y and W) polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-D) administered to toddlers.METHODS: Children were randomly assigned (1:1) at study entry to receive MenACYW-D at 12 and 18 months of age (group 1; n=61) or meningococcal serogroup C conjugate vaccine (MCC) at 12 months of age (group 2; n=62). All received routine childhood immunizations. A, C, Y and W antibody titres were measured in group 1 before and one month after the 18-month MenACYW-D vaccination and were measured in group 2 at one and seven months post-MCC vaccination. Antibodies elicited by diphtheria and tetanus toxoids, and acellular pertussis vaccine adsorbed combined with inactivated poliomyelitis vaccine andHaemophilus influenzaeb conjugate (DTaP-IPV-Hib) vaccine coadministered at the 18-month vaccination were measured one month later. Safety data were collected.RESULTS: At 19 months of age, ≥96% in group 1 achieved protective titres for the four meningococcal serogroups after dose 2; 67% in group 2 exhibited protective titres against serogroup C 28 days after MCC vaccination at 12 months of age, declining to 27% seven months later. DTaP-IPV-Hib elicited high antibody concentrations/titres in groups 1 and 2, consistent with historical values. The safety profiles after each dose generated no unexpected safety signals; no serious adverse events were related to vaccination.DISCUSSION: A two-dose series of MenACYW-D given concomitantly with a DTaP-IPV-Hib booster dose at 18 months of age demonstrated a good immunogenicity and safety profile. A two-dose series of MenACYW-D can be used as an alternative to one dose of MCC and provides protection against additional serogroups (NCT ID: NCT01359449).
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Ceyhan, Mehmet, Yasemin Ozsurekci, Cihangül Bayhan, Nezahat Gurler, Enes Sali, Melike Keser Emiroglu, Fatma Nur Öz, et al. "682. The Changing Epidemiology of Bacterial Meningitis During 2015–2017 in Turkey: A Hospital-Based Prospective Surveillance Study." Open Forum Infectious Diseases 5, suppl_1 (November 2018): S246. http://dx.doi.org/10.1093/ofid/ofy210.689.
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Abstract Background The etiology of bacterial meningitis in Turkey has been changed after the implementation of conjugated vaccines against Streptococcus pneumonia and Haemophilus influenzae type b (Hib) in Turkish national immunization schedule. Methods. This prospective study was conducted in 25 hospitals located seven regions of Turkey (representing 30% of Turkey population) and children aged between 1 month and 18 years with suspected meningitis and hospitalized were included. Cerebrospinal fluid samples were collected and bacterial identification was made according to the multiplex PCR assay results. Results. During the study period, 927 children were hospitalized for suspected meningitis and Hib (n:1), S. pneumonia (n:17) and Neisseria meningitidis (n:59) were detected in 77 samples (Figure 1, Table 1). During 2015–2016, N. meningitidis serogroup W, B, A, Y, X frequencies were as 5 (13.9%), 16 (44.4%), 1 (2.8%), 1 (2.8%), 1 (2.8%), respectively. There were 12 nongroupable N. meningitidis samples and serogroup C was not detected. In 2017, of meningococcal meningitis serogroup B, W, A, Y and X were identified in two (8.7%), 15 (65.2%), two (8.7%), 1 (4.3%) and 1 (4.3%) cases, respectively (Figure 2). There were four deaths in this study period, all of them were caused by N. meningitidis serogroup B and three of them were under 1 year old. Conclusion. The epidemiology of meningococcal diseases has been varied in time with or without any apparent reasons. Hajj is a well-known cause for serogroup W epidemics and serogorup W was the most common cause of meningitis in Turkey during 2009–2014 as in other Middle East countries. After the impact of serogroup W epidemics related to Hajj seen in 2010’s was diminished, serogroup B has been leading cause of childhood meningitis since 2015. In countries affected from Hajj like Turkey, vaccination of children with serogroup B meningococcal vaccine as well as quadrivalentconjugated vaccine seems to be very important. It should be kept in mind that meningococcal epidemiology is dynamic and needed to be closely monitored to detect changes in years Disclosures All authors: No reported disclosures.
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GREIN, T., and D. O’FLANAGAN. "Day-care and meningococcal disease in young children." Epidemiology and Infection 127, no. 3 (December 2001): 435–41. http://dx.doi.org/10.1017/s0950268801005817.
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The Republic of Ireland has the highest incidence of meningococcal disease in Europe with 40% of all cases occurring in children under the age of 5 years. Attending day-care increases the risk of certain infections, including Haemophilus influenzae type b (Hib) meningitis. The risk of meningococcal disease associated with day-care is not known. We conducted a case-control study among pre-school children with 130 laboratory-confirmed cases and 390 controls, matched on age, gender and place of residence, to determine if day-care attendance was a risk factor for meningococcal disease. Multivariate analysis showed that day-care attenders had a lower risk of disease than non-attenders (OR 0·3, 95% CI 0·1–0·7) whereas the number of adults in a household, and household crowding were independent risk factors for disease. Asymptomatic carriers of Neisseria meningitidis are the main source of transmission and these carriers are usually adults. Regular day-care attendance may reduce this risk by removing children from close and prolonged contact with adults.
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Findlow, Helen, Samba Sow, Ray Borrow, Milagritos Tapia, Fadima Cheick Haidara, Adebayo K. Akinsola, Olubukola T. Idoko, et al. "Meningococcal Group C and W135 Immunological Hyporesponsiveness in African Toddlers." Clinical and Vaccine Immunology 18, no. 9 (July 13, 2011): 1492–96. http://dx.doi.org/10.1128/cvi.05020-11.
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ABSTRACTA phase II clinical study was conducted in African toddlers (aged 12 to 23 months), with subjects receiving either investigational meningococcal group A conjugate (PsA-TT), meningococcal ACWY polysaccharide (PsACWY), orHaemophilus influenzaetype b (Hib-TT) vaccine. Ten months following vaccination, the 3 study groups were further randomized to receive a dose of PsA-TT, a 1/5 dose of PsACWY, or a dose of Hib-TT vaccine. Group A serum bactericidal antibody (SBA) results have been reported previously, with PsA-TT demonstrating superior immunogenicity versus PsACWY vaccine. Immunogenicity for serogroups W135 and C was assessed by SBA assay to investigate the impact of multiple doses in this age group. Blood samples were taken prior to vaccination, 28 days and 40 weeks post-primary vaccination, and 7 and 28 days post-booster vaccination with a 1/5 dose of PsACWY. Subjects who had previously received a full dose of PsACWY had W135 SBA geometric mean titers (GMTs) of 26.1 and 4.4 at 7 and 28 days post-booster vaccination with a 1/5 PsACWY dose, respectively, whereas the W135 SBA GMTs of naïve subjects at these time points following vaccination with a 1/5 dose of PsACWY were 861.1 and 14.6, respectively. Similar differences were observed for serogroup C, with SBA GMTs of 99 and 5.9 at 7 and 28 days post-booster vaccination with a 1/5 dose of PsACWY, respectively, for naïve subjects, compared to 4.1 and 3.2 for previously vaccinated subjects. Immunologic hyporesponsiveness for groups C and W135 was observed following a full dose of PsACWY vaccine at 12 to 23 months of age and a 1/5 dose of PsACWY 10 months later compared to the case for PsACWY-naïve subjects receiving a 1/5 dose of PsACWY vaccine.
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Miller, Elizabeth, Nick Andrews, Pauline Waight, Helen Findlow, Lindsey Ashton, Anna England, Elaine Stanford, et al. "Safety and Immunogenicity of Coadministering a Combined Meningococcal Serogroup C andHaemophilus influenzaeType b Conjugate Vaccine with 7-Valent Pneumococcal Conjugate Vaccine and Measles, Mumps, and Rubella Vaccine at 12 Months of Age." Clinical and Vaccine Immunology 18, no. 3 (December 29, 2010): 367–72. http://dx.doi.org/10.1128/cvi.00516-10.
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ABSTRACTThe coadministration of the combined meningococcal serogroup C conjugate (MCC)/Haemophilus influenzaetype b (Hib) vaccine with pneumococcal conjugate vaccine (PCV7) and measles, mumps, and rubella (MMR) vaccine at 12 months of age was investigated to assess the safety and immunogenicity of this regimen compared with separate administration of the conjugate vaccines. Children were randomized to receive MCC/Hib vaccine alone followed 1 month later by PCV7 with MMR vaccine or to receive all three vaccines concomitantly. Immunogenicity endpoints were MCC serum bactericidal antibody (SBA) titers of ≥8, Hib-polyribosylribitol phosphate (PRP) IgG antibody concentrations of ≥0.15 μg/ml, PCV serotype-specific IgG concentrations of ≥0.35 μg/ml, measles and mumps IgG concentrations of >120 arbitrary units (AU)/ml, and rubella IgG concentrations of ≥11 AU/ml. For safety assessment, the proportions of children with erythema, swelling, or tenderness at site of injection or fever or other systemic symptoms for 7 days after immunization were compared between regimens. No adverse consequences for either safety or immunogenicity were demonstrated when MCC/Hib vaccine was given concomitantly with PCV and MMR vaccine at 12 months of age or separately at 12 and 13 months of age. Any small differences in immunogenicity were largely in the direction of a higher response when all three vaccines were given concomitantly. For systemic symptoms, there was no evidence of an additive effect; rather, any differences between schedules showed benefit from the concomitant administration of all three vaccines, such as lower overall proportions with postvaccination fevers. The United Kingdom infant immunization schedule now recommends that these three vaccines may be offered at one visit at between 12 and 13 months of age.
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Southern, Jo, Ray Borrow, Nick Andrews, Rhonwen Morris, Pauline Waight, Michael Hudson, Paul Balmer, Helen Findlow, Jamie Findlow, and Elizabeth Miller. "Immunogenicity of a Reduced Schedule of Meningococcal Group C Conjugate Vaccine Given Concomitantly with the Prevenar and Pediacel Vaccines in Healthy Infants in the United Kingdom." Clinical and Vaccine Immunology 16, no. 2 (December 17, 2008): 194–99. http://dx.doi.org/10.1128/cvi.00420-08.
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ABSTRACT This study investigated the use of two doses of three different meningococcal group C conjugate (MCC) vaccines when given for primary immunization with a seven-valent pneumococcal conjugate vaccine (PCV7) and Pediacel, a combination product containing five acellular pertussis components, diphtheria and tetanus toxoids, Haemophilus influenzae type b (Hib) conjugate, and inactivated-poliovirus vaccine. The immune response after a single dose of MCC is also presented. Infants were randomized to receive two doses of one of the MCC vaccines and PCV7 at 2 and 3 months or at 2 and 4 months of age. Meningococcal group C serum bactericidal antibody (SBA) geometric mean titers, Hib-polyribosylribitol phosphate (PRP) immunoglobulin G (IgG) geometric mean concentrations (GMCs), and diphtheria and tetanus antitoxin GMCs, together with the proportions of infants achieving putative protective levels, were determined. A total of 393 infants were recruited. Following the first dose of NeisVac-C (MCC conjugated to tetanus toxoid), 97% of infants achieved protective levels (SBA titer of ≥8), compared with 80% and 53%, respectively, for Menjugate and Meningitec (both of which are conjugated to CRM197). SBA responses to MCC vaccines were not significantly different when administered at 2 and 3 or 2 and 4 months of age. Following two doses of each MCC, 98 to 100% of infants achieved protective levels. Both PRP IgG and tetanus responses were significantly enhanced when Pediacel was coadministered with NeisVac-C. This study demonstrates that NeisVac-C and Menjugate generate good immunogenicity after the first dose at 2 months of age when coadministered with PCV7 and Pediacel and merit further investigation in single-dose priming strategies.
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Vesikari, Timo, Aino Karvonen, Ray Borrow, Nick Kitchin, Martine Baudin, Stéphane Thomas, and Anne Fiquet. "Results from a Randomized Clinical Trial of Coadministration of RotaTeq, a Pentavalent Rotavirus Vaccine, and NeisVac-C, a Meningococcal Serogroup C Conjugate Vaccine." Clinical and Vaccine Immunology 18, no. 5 (March 9, 2011): 878–84. http://dx.doi.org/10.1128/cvi.00437-10.
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ABSTRACTRotaTeq (Merck & Co. Inc./Sanofi Pasteur MSD) is a three-dose, oral pentavalent rotavirus vaccine for the immunization of infants from 6 weeks of age for the prevention of rotavirus gastroenteritis. The primary objective of the present trial was to demonstrate that RotaTeq can be coadministered with meningococcal serogroup C conjugate vaccine (MenCC; NeisVac-C; Baxter Healthcare) to healthy infants without impairing the protective immune responses to MenCC. This was an open-label, randomized, comparative study conducted in Finland. The study was designed to assess concomitant versus sequential administration of RotaTeq and MenCC on the immune response to both vaccines. Healthy infants (n= 247), aged 6 to 7 weeks, were recruited. Coadministration of MenCC with RotaTeq was noninferior to sequential administration for the seroprotection rate against meningococcal serogroup C (the proportion of infants with a serum bactericidal antibody titer using baby rabbit complement of ≥8 was 100% in both groups). The other responses to MenCC (titer of ≥1:128, ≥4-fold increase in titer, and geometric mean titers [GMTs]) and the responses to RotaTeq (IgA and SNA response to G1 to G4 and P1A[8], GMTs, and ≥3-fold increase in titer) were comparable between groups, including a ≥3-fold IgA increase in >96% of the infants in both groups. Concomitant administration of the first doses of MenCC, diphtheria and tetanus toxoids and acellular pertussis vaccine, inactivated poliovirus vaccine, andHaemophilus influenzaetype b conjugate vaccine (DTaP-IPV-Hib), and RotaTeq was associated with a higher rate of vomiting and diarrhea than concomitant administration of MenCC and DTaP-IPV-Hib, but that was not observed after the second concomitant administration. The convenience of concomitant administration of RotaTeq and MenCC may, however, outweigh the additive effect of mostly mild adverse events reported after the individual administration of each vaccine. These results support the coadministration of RotaTeq and MenCC.
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Alderson, Mark R., Jo Anne Welsch, Katie Regan, Lauren Newhouse, Niranjan Bhat, and Anthony A. Marfin. "Vaccines to Prevent Meningitis: Historical Perspectives and Future Directions." Microorganisms 9, no. 4 (April 7, 2021): 771. http://dx.doi.org/10.3390/microorganisms9040771.
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Despite advances in the development and introduction of vaccines against the major bacterial causes of meningitis, the disease and its long-term after-effects remain a problem globally. The Global Roadmap to Defeat Meningitis by 2030 aims to accelerate progress through visionary and strategic goals that place a major emphasis on preventing meningitis via vaccination. Global vaccination against Haemophilus influenzae type B (Hib) is the most advanced, such that successful and low-cost combination vaccines incorporating Hib are broadly available. More affordable pneumococcal conjugate vaccines are becoming increasingly available, although countries ineligible for donor support still face access challenges and global serotype coverage is incomplete with existing licensed vaccines. Meningococcal disease control in Africa has progressed with the successful deployment of a low-cost serogroup A conjugate vaccine, but other serogroups still cause outbreaks in regions of the world where broadly protective and affordable vaccines have not been introduced into routine immunization programs. Progress has lagged for prevention of neonatal meningitis and although maternal vaccination against the leading cause, group B streptococcus (GBS), has progressed into clinical trials, no GBS vaccine has thus far reached Phase 3 evaluation. This article examines current and future efforts to control meningitis through vaccination.
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Bash, Margaret C., Freyja Lynn, Brian Mocca, Ray Borrow, Helen Findlow, Musa Hassan-King, Marie-Pierre Preziosi, et al. "Development and Use of a Serum Bactericidal Assay Using Pooled Human Complement To Assess Responses to a Meningococcal Group A Conjugate Vaccine in African Toddlers." Clinical and Vaccine Immunology 21, no. 5 (March 26, 2014): 755–61. http://dx.doi.org/10.1128/cvi.00812-13.
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ABSTRACTA meningococcal group A polysaccharide (PS) conjugate vaccine (PsA-TT) has been developed for African countries affected by epidemic meningitis caused byNeisseria meningitidis. Complement-mediated serum bactericidal antibody (SBA) assays are used to assess protective immune responses to meningococcal vaccination. Human complement (hC′) was used in early studies demonstrating antibody-mediated protection against disease, but it is difficult to obtain and standardize. We developed and evaluated a method for sourcing hC′ and then used the SBA assay with hC′ (hSBA) to measure bactericidal responses to PsA-TT vaccination in 12- to 23-month-old African children. Sera with active complement from 100 unvaccinated blood donors were tested for intrinsic bactericidal activity, SBA titer using rabbit complement (rSBA), and anti-group A PS antibody concentration. Performance criteria and pooling strategies were examined and then verified by comparisons of three independently prepared hC′ lots in two laboratories. hSBA titers of clinical trial sera were then determined using this complement sourcing method. Two different functional antibody tests were necessary for screening hC′. hSBA titers determined using three independent lots of pooled hC′ were within expected assay variation among lots and between laboratories. In African toddlers, PsA-TT elicited higher hSBA titers than meningococcal polysaccharide or Hib vaccines. PsA-TT immunization or PS challenge of PsA-TT-primed subjects resulted in vigorous hSBA memory responses, and titers persisted in boosted groups for over a year. Quantifying SBA using pooled hC′ is feasible and showed that PsA-TT was highly immunogenic in African toddlers.
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Grace, Rachael F., Rachel E. Mednick, and Ellis J. Neufeld. "Compliance with Immunizations in Splenectomized Individuals: A Study of the Splenectomized Hereditary Spherocytosis Population." Blood 112, no. 11 (November 16, 2008): 1316. http://dx.doi.org/10.1182/blood.v112.11.1316.1316.
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Abstract Overwhelming infection by encapsulated bacteria is a significant short- and longterm risk of splenectomy. Vaccines are available for organisms to which asplenic patients are susceptible, i.e. S. pneumoniae, N. meningitidis, and H. influenza-B. Therefore, strict adherence to the immunizations against these organisms is recommended. In addition, after splenectomy, antibiotic prophylaxis is advised, although guidelines for chemoprophylaxis are not consistent across hematology and surgical disciplines. METHODS: We performed a cross sectional study to determine immunization status, antibiotic use, and patient knowledge after splenectomy in the hereditary spherocytosis (HS) population. Subjects were ascertained from the recent and archival records of the hematology, surgery, and pathology departments at Children’s Hospital Boston. Addresses of former patients were sought by public record review and through current patient/family members. A strategy of expanding families by phone contact for this genetic disorder (commonly autosomal dominant) allowed ascertainment of older relatives of current patients. Vaccine status was by self- or parental-report. RESULTS: We enrolled 77 splenectomized HS patients (38% male, mean age 34.7 y, mean age at splenectomy 10.9 y). Of the asplenic HS patients interviewed, only 20 (26%) reported receiving all of the recommended post-splenectomy vaccines (Table 1). However, 65% of splenectomized individuals reported that a physician had told them that their immunizations were up-to-date. Among the asplenic HS patients, the likelihood of receiving a particular vaccine was related to the number of years the vaccine had been available: PPV23 vaccine (1977) 96% > MPSV4 (1981) 78% > Hib (1987) 64% > PCV7 (2000) 42% > MCV4 (2005) 27%. As expected, asplenic patients < age 20 y were much more likely to have received the new conjugate vaccines than older adults (PCV 83% vs. 23%, P<0.001; MCV4 87% vs. 17%, P<0.001; Hib 96% vs. 52%; P<0.001). Of the 77 splenectomized individuals, 44 stated that they had taken prophylactic antibiotics following splenectomy. Of these 44, 25% stopped prophylaxis within the year of splenectomy. There were 14 reported cases of serious infection (sepsis, bacterial meningitis, or bacterial pneumonia) in splenectomized patients. Of these, 2/14 were up-to-date for immunizations. 13 of the 93 unsplenectomized individuals experienced serious infection (difference N.S.). 22 of 77 splenectomized patients interviewed were unaware of their immunization status, and approximately 75% of patients were not up-to-date on all currently recommended vaccinations. These numbers may reflect lack of patient knowledge about the risk of infection following splenectomy, and they demonstrate room for substantial improvement in pre-and post-splenectomy management of HS patients, whose splenectomies are virtually always planned and elective. Preoperative immunization is key, and pediatric hematology clinics have a unique opportunity to ascertain and provide catch-up and booster vaccinations to splenectomized adult relatives of their patients. A greater effort must be made by hematologists, primary care providers, and surgeons to educate patients about the risks of splenectomy, and the positive contributions that immunizations provide in protecting asplenic individuals from infection. Table 1. Summary of adherence to immunizations PCV7 PPV23 MCV4 MPSV4 Influenza Hib All Recommended Immunizations PCV7, Pneumococcal Conjugate Vaccine; PPV23, Pneumococcal Polysaccharide Vaccine; MCV4, Meningococcal Conjugate Vaccine; MPSV4, Meningococcal Polysaccharide Vaccine; Hib, Haemophilus influenza Type B Conjugate Vaccine 32/77 74/77 21/77 60/77 67/77 49/77 20/77
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Haddad-Boubaker, Sondes, Marwa Lakhal, Cyrine Fathallah, Aida Bouafsoun, Maher Kharrat, Monia Khemiri, Amel Kechrid, and Hanen Smaoui. "Molecular diagnosis of bacterial meningitis by multiplex real time PCR in Tunisian children." Journal of Infection in Developing Countries 12, no. 04 (April 30, 2018): 235–43. http://dx.doi.org/10.3855/jidc.9650.
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Introduction: Bacterial meningitis is a medical emergency requiring a fast and reliable diagnosis. Molecular methods such as real-time PCR (rt-PCR) offer an attractive alternative. Thus, this study aims to establish multiplex rt-PCRs detecting N. meningitidis, S. pneumoniae and H. influenzae b from cerebrospinal fluid in Tunisian children beyond neonatal age.
Methodology: Using bioinformatic tools and experimentation, we validated the specificity and optimal criteria of PCRs for primers and probes of plyA (S. pneumoniae), ctrA and sodC (N. meningitidis) and bexA genes (H. influenzae b). We performed one multiplex RT-PCR for detection of S. pneumoniae and N. meningitidis targeting plyA and ctrA, sodC genes respectively, simultaneously with a singleplex RT-PCR for H. influenzae b. The sensitivity and specificity of our methods were assessed. Then, we tested our methods for 122 CSF samples collected from suspected meningitis cases between 2014 and 2016 in Bechir Hamza Children’s Hospital of Tunis.
Results: Our results have shown the sensitivity of the designed PCRs was up to 10-4 DNA dilution and the specificity was 100%. PCR evaluation has shown 51 positive samples: 38 of pneumococcal cases, 12 meningococcal cases, 1 case of H. influenzae b with 8.57% and 50% of supplementary positive cases rates respectively.
Conclusions: Our assay proved to be very sensitive, specific and rapid for bacterial meningitis diagnosis. In the recent context of Hib vaccination, the possibility of detecting S. pneumoniae and N. meningitidis separately constitute an attractive opportunity. Nevertheless, simultaneous detection of Hib remains relevant in specific clinical context and for epidemiologic study.
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Luthra, Karuna, Anna Zimmermann Jin, Prarthana Vasudevan, Karen Kirk, Carol Marzetta, and Lois Privor-Dumm. "Assessing vaccine introduction and uptake timelines in Gavi-supported countries: are introduction timelines accelerating across vaccine delivery platforms?" BMJ Global Health 6, no. 5 (May 2021): e005032. http://dx.doi.org/10.1136/bmjgh-2021-005032.
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BackgroundPrevious studies identified factors influencing regulatory approval to introduction timelines for individual vaccines. However, introduction and uptake timelines have not been comprehensively assessed across the portfolio of Gavi-supported vaccines.MethodsWe analysed median times between introduction milestones from vaccine licensure to country introduction and uptake across six vaccine-preventable diseases (VPDs), three delivery platforms and 69 Gavi-supported countries. Data were gathered from public, partner and manufacturer records. VPDs and prequalified vaccines analysed included Haemophilus influenzae type b (DTwP-HepB-Hib, pentavalent), pneumococcal disease (pneumococcal conjugate vaccine, PCV), rotavirus diarrhoea (rotavirus vaccine, RVV), cervical cancer (human papillomavirus vaccine, HPV), polio (inactivated polio vaccine, IPV) and meningococcal meningitis (meningococcal group A conjugate vaccine, MenA).ResultsMedian time from first vaccine licensure to first Gavi-supported country introduction across VPDs at a ‘global level’ (Gavi-supported countries) was 5.4 years. Once licensed, MenA vaccines reached first introduction fastest (campaign=0.6 years; routine immunisation (RI)=1.7 years). Most introductions were delayed. Country uptake following first introduction was accelerated for more recently Gavi-supported RI vaccines compared with older ones.ConclusionFactors accelerating timelines across delivery platforms included rapid product prequalifications by WHO, strong initial recommendations by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization, achieving target product profiles on first vaccine licensure within a VPD and completing several VPD milestones at a global level prior to licensure. Milestones required for introduction in Gavi-supported countries should start prior or in parallel to licensure to accelerate uptake of vaccines delivered through diverse delivery platforms.
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Tejedor, Juan-Carlos, F??lix Ome??aca, Jos?? Garc??a-Sicilia, Carlos Esporr??n, Vicente Molina, Josep Mar??s, Marta Muro, et al. "ANTIBODY PERSISTENCE AFTER PRIMARY VACCINATION WITH A HEXAVALENT DTPa-HBV-IPV/HIB VACCINE COADMINISTERED WITH A MENINGOCOCCAL C-CRM197 VACCINE AND RESPONSE TO A DTPa-IPV/HIB BOOSTER AT 18 MONTHS OF AGE." Pediatric Infectious Disease Journal 25, no. 10 (October 2006): 943–45. http://dx.doi.org/10.1097/01.inf.0000237917.60734.05.
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Oliver, Jennifer L., Christine Sadorge, Florence Boisnard, Matthew D. Snape, Richard Tomlinson, Rebecca Mann, Peter Rudd, et al. "Randomized clinical trial of DTaP5-HB-IPV-Hib vaccine administered concomitantly with meningococcal serogroup C conjugate vaccines during the primary infant series." Vaccine 38, no. 35 (July 2020): 5718–25. http://dx.doi.org/10.1016/j.vaccine.2020.06.015.
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Schmitt, Heinz-J., Katrin Simone Steul, Astrid Borkowski, Francesca Ceddia, Ellen Ypma, and Markus Knuf. "Two versus three doses of a meningococcal C conjugate vaccine concomitantly administered with a hexavalent DTaP-IPV-HBV/Hib vaccine in healthy infants." Vaccine 26, no. 18 (April 2008): 2242–52. http://dx.doi.org/10.1016/j.vaccine.2008.02.041.
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Zhang, Q., S. Choo, J. Everard, R. Jennings, and A. Finn. "Mucosal Immune Responses to Meningococcal Group C Conjugate and Group A and C Polysaccharide Vaccines in Adolescents." Infection and Immunity 68, no. 5 (May 1, 2000): 2692–97. http://dx.doi.org/10.1128/iai.68.5.2692-2697.2000.
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ABSTRACT Previous studies in children have shown that Haemophilus influenzae type b (Hib) polysaccharide conjugate vaccines can reduce nasopharyngeal carriage of H. influenzae and provide herd immunity and suggest that this effect is mediated through mucosal antibodies. As this phenomenon may operate in other invasive bacterial infections which are propagated by nasopharyngeal carriage, mucosal antibody responses to meningococcal C conjugate and A/C polysaccharide vaccines were investigated. A total of 106 school children aged 11 to 17 years were randomized to receive a single dose of either conjugate or polysaccharide vaccine in an observer-blind study. Before and at 1, 6, and 12 months after immunization, samples of unstimulated saliva were collected and assayed by enzyme-linked immunosorbent assay for group C polysaccharide-specific immunoglobulin A (IgA), IgA1, IgA2 and secretory component, IgG antibodies, and total IgG and IgA. A subset of serum samples were also assayed for specific IgA and IgG antibodies. The concentrations of specific IgA and IgG in saliva were expressed both as nanograms per milliliter and as nanograms per microgram of total IgA or IgG. One month after immunization, significant increases in antibody titers (both IgA and IgG) were observed in saliva in both groups. There were significant subsequent falls in antibody titers by 6 months. Anti-meningococcal C-specific secretory component and IgA antibody titers were closely correlated (r = 0.85,P < 0.001), but there was no significant correlation between salivary and serum IgA titers, suggesting that IgA antibodies are locally produced. Significant correlation was found between salivary and serum IgG titers (r = 0.52,P < 0.01), suggesting that salivary IgG may be serum derived. Compared with polysaccharide vaccine, the conjugate vaccine induced significantly higher salivary IgG responses (P< 0.05), although there were no significant differences between salivary IgA responses to the two vaccines. The conjugate vaccine induced greater salivary IgG responses than a polysaccharide vaccine. Both vaccines induced significant salivary IgA antibodies. Further studies are needed to establish the functional significance of these mucosal responses.
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Beri, Suresh, Darshan Gandhi, and Neil Ravenscroft. "Use of NMR as an analytical tool in the process development of conjugate vaccines against Haemophilus influenzae type b (Hib) and meningococcal serogroup A (MenA)." Biologicals 62 (November 2019): 102–6. http://dx.doi.org/10.1016/j.biologicals.2019.10.005.
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Smith, Louise, Elizabeth Ryan, Russell D. Keenan, and Rekha Thangavelu. "No Demonstrable Benefit of Penicillin in a Vaccinated Population of Children with Sickle Cell Disorder." Blood 132, Supplement 1 (November 29, 2018): 4927. http://dx.doi.org/10.1182/blood-2018-99-119768.
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Abstract UK and many National guidelines advise on the use of prophylactic antibiotics, immunisation and patient education to minimise the risk of severe infections by encapsulated organisms in patients with Sickle Cell Disorder. The UK vaccination schedule for sickle cell anaemia patients includes Pneumococcal, Meningococcal and Haemophilus influenzae type B (Hib) immunisation. Prophylactic Penicillin V is recommended as additional protection against Streptococcus pneumoniae (S.pneumoniae). In light of the findings in the papers by Oligbu et al, 2017, and Martin et al 2018, we aimed to retrospectively compare compliance with prophylactic Penicillin V against infection rates by S.pneumoniae,Neisseria meningitidis (N.meningitidis) and Hib . We hypothesised that the incidence of infections with IPD and other encapsulated organisms would be greater in patients who were not adherent with Penicillin V. Patients were considered compliant with prophylactic Penicillin V if 75% or more of their urine samples gave positive results. The study population consisted of 52 Sickle Cell patients, ranging from age 3 to 20years. Three patients were excluded as no urine samples had been collected from them in the 5 year period. Of the remaining 49 patients only 9 patients (18%) were had good adherence with Penicillin V over a 5 year period. 100% of patients received prevenar vaccination (PCV-7 or PCV 13). 73% received additional pneumovax. We retrospectively reviewed microbiology culture reports over a five year period. All microbiology reports were reviewed from the period, with the virulent encapsulated organisms of S.pneumoniae,N.meningitidis and Hib recorded, alongside any other bacterial infections. No patients had microbiological evidence of infection by virulent encapsulated bacteria. Six patients had cultures positive for other organisms: two Staphylococcus aureus positive sputum cultures, one Salmonella positive stool culture, two urine cultures positive for Escherichia coli, and one skin wound swab positive for Streptococcus pyogenes. Of the 6 organisms identified, 3 occurred in patients compliant with Penicillin V, and 3 occurred in patients who were non-compliant. Patients compliant with Penicillin V formed a small cohort (n=9), resulting in an apparently high incidence of infection (33%). In the non-compliant cohort (n=40), 8% had shown infection. Analysis by Fisher's Exact Test confirmed no significant difference in the incidence of infection between the two groups (p= 0.06). In a sickle cell disorder population where 82% of the patients were not 100% compliant with prophylactic Penicillin V, no significant encapsulated bacteria (S.pneumoniae,N.meningitidis or Hib) were cultured in a 5 year period in our cohort. Non-compliance with prophylactic Penicillin V was not associated with an increased incidence of infections by encapsulated organisms. The UK study (Oligbu et al) on IPD was performed in the PCV13 era and states a 49x increased risk of developing IPD and a 5x increase in mortality in children with sickle cell compared to their peers. However, most IPD cases were due to non-vaccine serotypes. A similar study from the US (Martin et al) found deaths only in the PCV7 cohort, it does not state if the patients were vaccinated with pneumovax 23. In conclusion 82% of children did not adhere to penicillin. We have not demonstrated any benefit in adhering to prophylactic penicillin. Adherence is poor and alternative approaches of standby antibiotics should be considered. We suggest focusing on vaccination as a preventative strategy is of more benefit. Martin OO, Moquist KL, Hennessy,JM, Nelson SC. Invasive pneumococcal disease in children with sickle cell disease in the pneumococcal conjugate vaccine era. Pediatr Blood Cancer. 2018;65:e26713. https://doi.org/10.1002/pbc.26713 Oligbu G, Collins S , Streetly A, Dick, M, Ladhany, S. Risk of invasive pneumococcal disease in children with sickle cell disease in England: National observational cohort study, 2010 - 2015. Arch Dis Child 2017;102(Suppl1):A4-A4 Disclosures No relevant conflicts of interest to declare.
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Bauwens, Jorgen, Luis-Henri Saenz, Annina Reusser, Nino Künzli, and Jan Bonhoeffer. "Safety of Co-Administration Versus Separate Administration of the Same Vaccines in Children: A Systematic Literature Review." Vaccines 8, no. 1 (December 31, 2019): 12. http://dx.doi.org/10.3390/vaccines8010012.
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The growing number of available vaccines that can be potentially co-administered makes the assessment of the safety of vaccine co-administration increasingly relevant but complex. We aimed to synthesize the available scientific evidence on the safety of vaccine co-administrations in children by performing a systematic literature review of studies assessing the safety of vaccine co-administrations in children between 1999 and 2019, in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Fifty studies compared co-administered vaccines versus the same vaccines administered separately. The most frequently studied vaccines included quadrivalent meningococcal conjugate (MenACWY) vaccine, diphtheria and tetanus toxoids and acellular pertussis (DTaP) or tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccines, diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate (DTaP-HepB-IPV/Hib) vaccine, measles, mumps, and rubella (MMR) vaccine, and pneumococcal conjugate 7-valent (PCV7) or 13-valent (PCV13) vaccines. Of this, 16% (n = 8) of the studies reported significantly more adverse events following immunization (AEFI) while in 10% (n = 5) significantly fewer adverse events were found in the co-administration groups. Statistically significant differences between co-administration and separate administration were found for 16 adverse events, for 11 different vaccine co-administrations. In general, studies briefly described safety and one-third of studies lacked any statistical assessment of AEFI. Overall, the evidence on the safety of vaccine co-administrations compared to separate vaccine administrations is inconclusive and there is a paucity of large post-licensure studies addressing this issue.
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Tucker, Miriam E. "FDA Approves Meningococcus/Hib Vaccine." Pediatric News 46, no. 7 (July 2012): 11. http://dx.doi.org/10.1016/s0031-398x(12)70166-2.
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Haddad-Boubaker, Sondes, Marwa Lakhal, Cyrine Fathallah, Samar Mhimdi, Aida Bouafsoun, Amel Kechrid, and Hanen Smaoui. "Epidemiological study of bacterial meningitis in Tunisian children, beyond neonatal age, using molecular methods: 2014-2017." African Health Sciences 20, no. 3 (October 7, 2020): 1124–32. http://dx.doi.org/10.4314/ahs.v20i3.14.
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Background: Since the 1990s, the epidemiology of bacterial meningitis worldwide has changed thanks to vaccination. In Tunisia, the main causative pathogens were Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae serotype b (Hib). Only Hib vaccination was available during our study period.
Objectives: We performed a laboratory case report based-study of suspected bacterial meningitis in Northern Tunisia from January 2014 to June 2017.
Methods: CSF samples obtained from children beyond neonatal age with suspicion of meningitis were tested by two real time PCRs, targeting pneumococcus, meningococcus and Hib, and conventional methods.
Results: Using real-time PCR, 63 were positive including ten supplementary cases compared to conventional methods. A general decrease of bacterial meningitis cases was demonstrated comparing to previous data. Pneumococcus was predominant (69.84%) followed by meningococcus (28.57%) and Hib (1.59%). The main serotypes were 14, 19F, 6B and 23F for pneumococcus and serogroup B for meningococcus. Most cases occurred during cold season and children under one year were the most affect- ed by bacterial meningitis.
Conclusion: Our study suggests the predominance of pneumococcal cases. It may provide valuable data on meningitis epidemiology before the introduction of pneumococcal vaccine, which may be useful for future evaluation.
Keywords: Bacterial meningitis; children; Tunisia; PCR.
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Raza, M. W., M. M. Ogilvie, C. C. Blackwell, J. Stewart, R. A. Elton, and D. M. Weir. "Effect of respiratory syncytial virus infection on binding ofNeisseria meningitidisandHaemophilus influenzaetype b to a human epithelial cell line (HEp-2)." Epidemiology and Infection 110, no. 2 (April 1993): 339–47. http://dx.doi.org/10.1017/s095026880006828x.
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SUMMARYIt has been suggested that individuals might be more readily colonized with bacteria that cause meningitis through enhanced binding of the bacteria to virusinfected epithelial cells. As respiratory syncytial virus (RSV) affects infants and children in the age group also susceptible to bacterial meningitis, we tested the hypothesis that infection of HEp-2 cells by RSV might enhance binding ofNeisseria meningitidisorHaemophilus influenzaetype b (Hib). Attachment of fluorescein-labelled bacteria to HEp-2 cells was measured by flow cytometry, and RSV-infected cells bound significantly more meningococci (P< 0·001) and Hib (P< 0·01) than uninfected cells. Although the isolates expressed different antigenic characteristics (3 meningococci and 5 Hib), all showed a similar pattern of binding. The results are discussed with reference to the methods used for detection of bacterial binding and to interactions that might explain the increased binding to RSV-infected cells.
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Szenborn, Leszek, Hanna Czajka, Jerzy Brzostek, Ryszard Konior, Magalie Caubet, Liliana Ulianov, and Maarten Leyssen. "A Randomized, Controlled Trial to Assess the Immunogenicity and Safety of a Heptavalent Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Hib and Meningococcal Serogroup C Combination Vaccine Administered at 2, 3, 4 and 12–18 Months of Age." Pediatric Infectious Disease Journal 32, no. 7 (July 2013): 777–85. http://dx.doi.org/10.1097/inf.0b013e31828d6b20.
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Paye, Marietou F., Kadidja Gamougame, Sarah K. Payamps, Alicia R. Feagins, Daugla Doumagoum Moto, Ronelngar Moyengar, Nathan Naïbeï, et al. "Implementation of Case-Based Surveillance and Real-time Polymerase Chain Reaction to Monitor Bacterial Meningitis Pathogens in Chad." Journal of Infectious Diseases 220, Supplement_4 (October 31, 2019): S182—S189. http://dx.doi.org/10.1093/infdis/jiz366.
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Abstract Background Meningococcal serogroup A conjugate vaccine (MACV) was introduced in Chad during 2011–2012. Meningitis surveillance has been conducted nationwide since 2003, with case-based surveillance (CBS) in select districts from 2012. In 2016, the MenAfriNet consortium supported Chad to implement CBS in 4 additional districts and real-time polymerase chain reaction (rt-PCR) at the national reference laboratory (NRL) to improve pathogen detection. We describe analysis of bacterial meningitis cases during 3 periods: pre-MACV (2010–2012), pre-MenAfriNet (2013–2015), and post-MenAfriNet (2016–2018). Methods National surveillance targeted meningitis cases caused by Neisseria meningitidis, Haemophilus influenzae, and Streptococcus pneumoniae. Cerebrospinal fluid specimens, inoculated trans-isolate media, and/or isolates from suspected meningitis cases were tested via culture, latex, and/or rt-PCR; confirmed bacterial meningitis was defined by a positive result on any test. We calculated proportion of suspected cases with a specimen received by period, and proportion of specimens with a bacterial meningitis pathogen identified, by period, pathogen, and test. Results The NRL received specimens for 6.8% (876/12813), 46.4% (316/681), and 79.1% (787/995) of suspected meningitis cases in 2010–2012, 2013–2015, and 2016–2018, respectively, with a bacterial meningitis pathogen detected in 33.6% (294/876), 27.8% (88/316), and 33.2% (261/787) of tested specimens. The number of N. meningitidis serogroup A (NmA) among confirmed bacterial meningitis cases decreased from 254 (86.4%) during 2010–2012 to 2 (2.3%) during 2013–2015, with zero NmA cases detected after 2014. In contrast, proportional and absolute increases were seen between 2010–2012, 2013–2015, and 2016–2018 in cases caused by S. pneumoniae (5.1% [15/294], 65.9% [58/88], and 52.1% [136/261]), NmX (0.7% [2/294], 1.1% [1/88], and 22.2% [58/261]), and Hib (0.3% [1/294], 11.4% [10/88], and 14.9% [39/261]). Of specimens received at the NRL, proportions tested during the 3 periods were 47.7% (418), 53.2% (168), and 9.0% (71) by latex; 81.4% (713), 98.4% (311), and 93.9% (739) by culture; and 0.0% (0), 0.0% (0), and 90.5% (712) by rt-PCR, respectively. During the post-MenAfriNet period (2016–2018), 86.1% (678) of confirmed cases were tested by both culture and rt-PCR, with 12.5% (85) and 32.4% (220) positive by culture and rt-PCR, respectively. Conclusions CBS implementation was associated with increased specimen referral. Increased detection of non-NmA cases could reflect changes in incidence or increased sensitivity of case detection with rt-PCR. Continued surveillance with the use of rt-PCR to monitor changing epidemiology could inform the development of effective vaccination strategies.
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Southern, J., A. Crowley-Luke, R. Borrow, N. Andrews, and E. Miller. "Immunogenicity of one, two or three doses of a meningococcal C conjugate vaccine conjugated to tetanus toxoid, given as a three-dose primary vaccination course in UK infants at 2, 3 and 4 months of age with acellular pertussis-containing DTP/Hib vaccine." Vaccine 24, no. 2 (January 2006): 215–19. http://dx.doi.org/10.1016/j.vaccine.2005.07.060.
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Nascimento-Carvalho, Cristiana M., and Otávio A. Moreno-Carvalho. "Etiology of bacterial meningitis among children aged 2-59 months in Salvador, Northeast Brazil, before and after routine use of Haemophilus influenzae type b vaccine." Arquivos de Neuro-Psiquiatria 62, no. 2a (June 2004): 250–52. http://dx.doi.org/10.1590/s0004-282x2004000200011.
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OBJECTIVE: To describe the frequency of etiologic agents of bacterial meningitis (BM) among children aged 2-59 months in a sample of patients in Salvador, Northeast Brazil, with emphasis on the frequency of BM of unknown etiology (BMUE), just before, during and after the implementation of routine immunization of infants with Haemophilus influenzae type b (Hib) vaccination. METHOD: Demographic, clinical and cerebrospinal fluid (CSF) information was collected from the chart of every patient, aged 2-59 months, whose CSF exam was performed at the CSF Lab - José Silveira Foundation, between January 1989 and December 2001. Every CSF exam was completely performed according to standard methods. The etiologic diagnosis was based on either culture and/or latex-agglutination test. When the agent was only seen on Gram stained smear, the diagnosis was descriptive. BMUE was defined as: glucose < 40mg / dl, protein > 100 mg / dl, white blood cell count > 20 cells / mm³, percentage of neutrophils > 80%. RESULTS: Of 1519 patients, 894 (58.9%) had normal exams and BM was diagnosed in 95 (6.2%). Etiologic agents were: Hib (44.2%), meningococcus (13.7%), Gram-negative bacilli (11.6%), Mycobacterium tuberculosis (6.3%), pneumococcus (4.2%), other agents (4.2%); BMUE was diagnosed in 15.8% of cases with BM. By analysing the frequency of BMUE and Hib among all exams performed yearly, the peaks were recorded in 1989 (5.3%) and 1990 (16.9%), respectively, decreasing to 0.7% and 0% in 2001. CONCLUSION: It is possible that the implementation of the conjugate Hib vaccine during the 1990's has been decreasing not only the occurrence of Hib meningitis but also of BMUE.
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Delic, Snezana, Vera Mijac, Ina Gajic, Dusan Kekic, Lazar Ranin, Boris Jegorovic, Davor Culic, et al. "A Laboratory-Based Surveillance Study of Invasive Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae Diseases in a Serbian Pediatric Population—Implications for Vaccination." Diagnostics 11, no. 6 (June 9, 2021): 1059. http://dx.doi.org/10.3390/diagnostics11061059.
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The aim of this study was to present the epidemiology of invasive diseases caused by Neisseria meningitidis and Streptococcus pneumoniae in the pre-vaccine period, and Haemophilus influenzae in the post-vaccine period in a pediatric population from Serbia. Among the meningococci, serogroup B dominated (83%), followed by serogroup C (11.3%). High antigenic diversity was found, with fine type P1.5-1,10-4 being the most frequent. Moderate susceptibility to penicillin was common (55%). Within pneumococci, serotypes 19F, 14, 6B, 6A, 18C, 23F, 3, and 7F prevailed, while 19A was rare (3.6%). The coverages of PCV10 and PCV13 were 68% and 84%, respectively. Major sequence types were ST320, ST15, ST273, ST271, and ST81. Non-susceptibility to penicillin (66.7%), cefotaxime (37%), and macrolides (55%) was predominantly detected in vaccine-related serotypes. Among the 11 invasive H. influenzae isolates collected, there were six Hib, three non-type b, and two non-typeable strains (ntHi) that were antibiotic susceptible. These results imply a potential benefit of future Men-B vaccine implementations. For pneumococci, as PCV10 was recently introduced, a significant reduction of morbidity and antibiotic resistance might be expected. The efficiency of Hib vaccination is evident, but a shift towards non-type b and ntHi strains may be anticipated.
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Lai, Zengzu, and John R. Schreiber. "Outer Membrane Protein Complex of Meningococcus Enhances the Antipolysaccharide Antibody Response to Pneumococcal Polysaccharide–CRM197Conjugate Vaccine." Clinical and Vaccine Immunology 18, no. 5 (March 30, 2011): 724–29. http://dx.doi.org/10.1128/cvi.00053-11.
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ABSTRACTBacterial polysaccharides (PS) are T cell-independent antigens that do not induce immunologic memory and are poor immunogens in infants. Conjugate vaccines in which the PS is covalently linked to a carrier protein have enhanced immunogenicity that resembles that of T cell-dependent antigens. TheHaemophilus influenzaetype b (Hib) conjugate vaccine, which uses the outer membrane protein complex (OMPC) from meningococcus as a carrier protein, elicits protective levels of anti-capsular PS antibody (Ab) after a single dose, in contrast to other conjugate vaccines, which require multiple doses. We have previously shown that OMPC robustly engages Toll-like receptor 2 (TLR2) and enhances the early anti-Hib PS Ab titer associated with an increase in TLR2-mediated induction of cytokines. We now show that the addition of OMPC to the 7-valent pneumococcal PS-CRM197conjugate vaccine during immunization significantly increases the anti-PS IgG and IgM responses to most serotypes of pneumococcus contained in the vaccine. The addition of OMPC also increased the likelihood of anti-PS IgG3 production against serotypes 4, 6B, 9V, 18C, 19F, and 23F. Splenocytes from mice who had received OMPC with the pneumococcal conjugate vaccine produced significantly more interleukin-2 (IL-2), IL-4, IL-6, IL-10, tumor necrosis factor alpha (TNF-α), and gamma interferon (IFN-γ) than splenocytes from mice who received phosphate-buffered saline (PBS) plus the conjugate vaccine. We conclude that OMPC enhances the anti-PS Ab response to pneumococcal PS-CRM197conjugate vaccine, an effect associated with a distinct change in cytokine profile. It may be possible to reduce the number of conjugate vaccine doses required to achieve protective Ab levels by priming with adjuvants that are TLR2 ligands.
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Olsen, S. F., B. Djurhuus, K. Rasmussen, H. D. Joensen, S. O. Larsen, H. Zoffman, and I. Lind. "Pharyngeal carriage of Neisseria meningitidis and Neisseria lactamica in households with infants within areas with high and low incidences of meningococcal disease." Epidemiology and Infection 106, no. 3 (June 1991): 445–57. http://dx.doi.org/10.1017/s0950268800067492.
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SUMMARYIn a household survey in the Faroe Islands, an isolated community with hyperendemic occurrence of meningococcal disease due to serogroup B 15, 1604 persons were examined for pharyngeal carriage of Neisseria meningitidis and N. lactamica. Two areas were chosen having experienced high (HIA), and two having experienced low incidences (LIA) of disease. Living in HIA compared with LIA was associated with higher risk of N. meningitidis B 15 carriage and lower risk of N. lactamica carriage, with odds ratios of 2·7 (95% confidence interval (CI) 1·4–5·1, P = 0·003) and 0·41 (95% CI 0·31–0·53, P < 0·0001), respectively. In HIA the risk of N. meningitidis carriage was much lower in non-carriers than carriers of N. lactamica, with an odds ratio of 0·19 (95% CI 0·08–0·47, P = 0·0003); in LIA this association (odds ratio 0·51, P = 0·05) was much weaker. Children 0–14 years had substantially higher risk of being carriers of N. meningitidis group B 15 if the mothers were so, with an odds ratio of 11 (95% CI 4–29, P < 0·0001).
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Prescott, William A., Kelsey C. Violanti, and Nicholas M. Fusco. "Characterization of Vaccination Policies for Attendance and Employment at Day/Summer Camps in New York State." Journal of Pharmacy Practice 32, no. 4 (January 11, 2018): 382–87. http://dx.doi.org/10.1177/0897190017751947.
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Introduction: New York state requires day/summer camps to keep immunization records for all enrolled campers and strongly recommends requiring vaccination for all campers and staff. The objective of this study was to characterize immunization requirements/recommendations for children/adolescents enrolled in and staff employed at day/summer camps in New York state. Methods: An electronic hyperlink to a 9-question survey instrument was distributed via e-mail to 178 day/summer camps located in New York state cities with a population size greater than 100 000 people. A follow-up telephone survey was offered to nonresponders. The survey instrument included questions pertaining to vaccination documentation policies for campers/staff and the specific vaccines that the camp required/recommended. Fisher’s exact and Chi-square tests were used to analyze categorical data. Results: Sixty-five day/summer camps responded to the survey (36.5% response rate): 48 (73.8%) and 23 (41.8%) camps indicated having a policy/procedure for documenting vaccinations for campers and staff, respectively. Camps that had a policy/procedure for campers were more likely to have a policy/procedure for staff ( P = .0007). Age-appropriate vaccinations that were required/recommended for campers by at least 80% of camps included: measles, mumps, and rubella (MMR), diphtheria, tetanus, and pertussis (DTaP), hepatitis B, inactivated/oral poliovirus (IPV/OPV), Haemophilus influenzae type b (Hib), and varicella. Age-appropriate vaccinations that were required/recommended for staff by at least 80% of camps included: DTaP, hepatitis B, IPV/OPV, MMR, meningococcus, varicella, Hib, and tetanus, diphtheria, and pertussis (Tdap). Conclusion: Vaccination policies at day/summer camps in New York state appear to be suboptimal. Educational outreach may encourage camps to strengthen their immunization policies, which may reduce the transmission of vaccine-preventable diseases.
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Delvig, Alexei A., Brehima Koumare, Ralf W. Glasert, Jian-Fu Wang, Sigbert Jahn, and Mark Achtman. "Comparison of three human-murine heteromyeloma cell lines for formation of human hybridomas after electrofusion with human peripheral blood lymphocytes from meningococcal cases and carriers." Human Antibodies 6, no. 2 (June 1, 1995): 42–46. http://dx.doi.org/10.3233/hab-1995-6201.
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Jeria Navarro, S., S. P. Fernandez-Sanchez, V. Pomar, D. Lobo Prat, L. Sainz Comas, H. Park, A. García-Guillén, et al. "AB0804 ONE YEAR FOLLOW-UP SAFETY AND EFFICACY RESULTS OF VACCINATION PROTOCOL FROM A RHEUMATOLOGY CLINIC." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1426.2–1427. http://dx.doi.org/10.1136/annrheumdis-2021-eular.1801.
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Background:Patients with autoimmune inflammatory rheumatic diseases (AIIRD) have a higher burden of infectious diseases compared to the general population. This could be explained by the disturbances in their immune system response, comorbidities and immunosuppressive treatment.Vaccination is the most effective measure to prevent infections.Objectives:To describe a cohort of patients with AIIRD referred to the infectious disease´s unit according to the vaccination protocol.Methods:Restrospective and descriptive study of a cohort of 286 patients with AIIRD who were evaluated in the rheumatology service of a tertiary hospital in Barcelona and referred to the infectious disease´s unit according to the vaccination protocol among 1 year,between January 1rst December 31st, 2019. The vaccination protocol included serologies of human immunodeficiency virus,hepatitis A,B and C, varicella zoster,tuberculosis,measles,mumps and rubella virus.The recommended vaccines were H.influenzae b,S.pneumonia,influenza,hepatitis A and B(immunity absence),meningococcus c,tetanus – diphtheria (low antigenic load),poliomyelitis and human papillomavirus (not vaccinated).The patients included were diagnosed with a rheumatologic condition under immunosuppressive therapy. Demographic variables,diagnosis,treatment,vaccines administered,infections and adverse effects were collected.Results:Of 286 patients reviewed the mean age was 61, 4 (±14.4) years. The characteristics of the cohort are shown in Table 1. Most of the patients used csDMARDs 149 (52.1%), 77(26.9%) patients used combined treatment. Measles and rubella are part of the triple virus vaccines included in the systematic Spanish vaccination schedule, in our cohort 20 (7%) patients had negative serologies for measles and 26 (9%) for rubella. 57 (20%) patients had latent TB with positive Quantiferon.Forty-one (14.3%) were vaccinated before receiving immunosuppressive treatment. The less administered vaccine was influenza with 44.9% (vaccination rate in Spain in healthy population, in 2019-2020 was 51.2%).No serious adverse effects were reported in relation to the vaccination. The infectious complications during the follow-up period were bronchopneumonia in a patient with RA treated with certolizumab (1), herpes zoster infection in RA on adalimumab(1), recurrent otitis in RA on adalimumab(1), mycobacterium avium infection in RA on etanercept(1), TB reactivation in RA with GCs and csDMARDs(1) and Papilloma virus infection in SpA on ustekinumab (1).Table 1.CHARACTERISTICS OF COHORT OF PATIENTSSex n % (women/men)193/93 (67,5/32,5)Age, years ± DE61.4 ± 14.4Diagnoses AIIRD, n (%)Rheumatoid arthritis n (%)164 (57.3)Systemic lupus erythematosus n (%)6 (2.1)Sjögren´s syndrome n (%)9 (3.1)Systemic sclerosis n (%)1 (0.35)Inflammatory myopathie n (%)5 (1.7)Vasculitis n (%)36 (12.6)Polymyalgia rheumatica n (%)4 (1.4)Spondyloarthropathy n (%)46 (16.1)Others n (%)15 (5.2)Treatment AIIRDGCs n (%)116 (40.7)csDMARDs n (%)149 (52.1)bDMARDs n (%)80 (27.8)tsDMARDs n (%)7 (2.4)Others1 n (%)12 (4.2)GCs + csDMARDs n (%)59 (21)GCs + bDMARDs n (%)14 (4.9)GCs + csDMARDs + bDMARDs n (%)4 (1.4)VaccinesPCV 13 n (%)283 (99)PPSV23 n (%)265 (93)HiB n (%)265 (93)NM n (%)247 (86.7)Influenza n (%)128 (44.9)HBV n (%)121 (42.3)Vaccination before IS n (%)41 (14.3)Vaccination with IS n (%)244 (85.3)Other: Behcet,Adult Stills,Relapsing polychondritis,IGg4 related disease,SarcoidosisOthers1: Mycophenolic acid,cyclosporine and tacrolimusConclusion:In our cohort, the vaccination protocol proved to be a good tool to improve the vaccination rate of rheumatological patients, despite this, the vaccination of Hepatitis B and specially of influenza, continues to have a lower prevalence to general population.The vaccines were effective since none of the preventable infections occurred during follow up, despite the use of an immunosuppressant. Vaccination showed a good safety profile, without reported serious adverse effects or worsening of the underlying disease.Disclosure of Interests:None declared
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Kulasekararaj, Austin G., Anita Hill, Scott T. Rottinghaus, Saskia Langemeijer, Richard A. Wells, F. Ataulfo Gonzalez-Fernandez, Anna Gaya, et al. "Results from a Phase 3, Multicenter, Non-Inferiority Study of Ravulizumab (ALXN1210) Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with Eculizumab." Blood 132, Supplement 1 (November 29, 2018): 625. http://dx.doi.org/10.1182/blood-2018-99-119147.
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Abstract Introduction Ravulizumab, an innovative complement C5 inhibitor given every 8 weeks (q8w), was recently demonstrated in a large phase 3 study of patients (pts) with paroxysmal nocturnal hemoglobinuria (PNH) and naïve to complement inhibitor therapy to be non-inferior to eculizumab given every 2 weeks (q2w) across all endpoints that measured different aspects of PNH disease (transfusion avoidance [TA], lactate dehydrogenase normalization [LDH-N], percent LDH reduction, breakthrough hemolysis [BTH], Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue, and hemoglobin stabilization [HGB-S]) (Lee JW et al. EHA Learning Center, Jun 17, 2018; LB2603). PNH pts currently receiving eculizumab may experience treatment burden associated with the q2w dosing regimen. With the development of ravulizumab, PNH pts on prior eculizumab therapy can potentially switch to ravulizumab without interruption of treatment. The primary objective of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult PNH pts who were clinically stable after having been treated with eculizumab for at least 6 months. Methods In this phase 3, open-label, multicenter study (NCT03056040), adult pts with a documented diagnosis of PNH who were treated with labelled-dose eculizumab for >6 months having LDH levels ≤1.5 times the upper limit of normal at screening were randomly assigned 1:1 to continue eculizumab or switch to ravulizumab. Pts randomized to ravulizumab received weight-based loading [day 1]/maintenance doses [day 15 and q8w thereafter]: ≥40 to <60 kg body weight [2400/3000mg]; ≥60 to <100 kg [2700/3300mg]; ≥100 kg [3000/3600mg]) through day 183 (primary completion date). Pts randomized to eculizumab received 900mg q2w. All pts must have received vaccination against N. meningitidis. Primary efficacy endpoint was hemolysis, as measured by percentage change in LDH levels from baseline (BL) to day 183. Non-inferiority was declared if the upper bound of the 95% confidence interval (CI) for the difference in change of LDH from BL (ravulizumab-eculizumab) was <15%. Key secondary efficacy endpoints tested in a hierarchal manner were proportion of patients with BTH, change in quality of life assessed by FACIT-Fatigue score, TA (percentage of pts remaining transfusion-free), and proportion of pts with HGB-S from BL to day 183. Change from BL in free C5 level over time was also assessed. Results Of 208 pts screened, 197 pts were randomized (1:1) to ravulizumab or eculizumab, 195 received treatment (ravulizumab, n=97; eculizumab, n=98), and 191 pts completed 183 days of treatment. Pt demographics and baseline clinical characteristics were similar between treatment groups. On average, pts had received prior eculizumab therapy for 5.8 years. All pts received all planned infusions of study medication. Ravulizumab was statistically significantly noninferior to eculizumab for the primary and all key secondary endpoints, with all point estimates favoring ravulizumab: percentage change in LDH levels (difference of -9.21% [95% CI: -18.84, 0.42]), BTH (difference of -5.1 [95% CI -18.89, 8.89]), change in FACIT-Fatigue score (difference of 1.47 [-0.21, 3.15]), TA (difference of 5.5 [95% CI -4.27, 15.68]), and HGB-S (difference of 1.4 [-10.41, 13.31]) (Fig A, Fig B). Superiority testing of the primary endpoint (percentage change in LDH) did not reach statistical significance (P=0.0583 vs P<0.05 required). Complete inhibition of serum C5 (mean free C5 serum of <0.5 µg/mL) was observed by the end of the first ravulizumab infusion and was sustained throughout the treatment period (Fig C). The most frequently reported adverse event was headache (26.8% versus 17.3% for ravulizumab and eculizumab, respectively). There were no meningococcal infections or discontinuations due to adverse events. Conclusion Results of this large phase 3 study show that ravulizumab achieved noninferiority compared with eculizumab in pts with PNH on stable eculizumab therapy. Pts can be safely and effectively switched from eculizumab given q2w to ravulizumab given q8w. In pts previously stable on eculizumab, no pts switched to ravulizumab experienced BTH vs 5 pts on eculizumab during the 26-week treatment period. This may be related to optimized ravulizumab dosing compared to eculizumab, resulting in complete and sustained C5 inhibition for all pts. Figure. Figure. Disclosures Kulasekararaj: Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria, Other: Travel Support . Hill:Apellis: Consultancy, Honoraria; Bioverativ: Consultancy, Honoraria; Regeneron: Consultancy, Honoraria; Akari: Consultancy, Honoraria; Ra Pharma: Consultancy, Honoraria; Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria. Rottinghaus:Alexion Pharmaceuticals, Inc.: Employment, Equity Ownership. Wells:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria; Alexion Pharmaceuticals, Inc.: Honoraria, Other: Travel Support , Research Funding. Gonzalez-Fernandez:Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria. Gaya:Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria. Lee:Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria, Research Funding. Ojeda Gutierrez:Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria. Szer:Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria, Other: Travel Support , Research Funding. Risitano:Pfizer Inc.: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Amyndas Pharmaceuticals: Consultancy; Alnylam Pharmaceuticals, Inc.: Consultancy, Honoraria, Research Funding; Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Ra Pharmaceuticals, Inc.: Consultancy, Honoraria, Research Funding. Nakao:Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria; Kyowa Hakko Kirin Co., Ltd.: Honoraria; Novartis: Honoraria. Bachman:Alexion Pharmaceuticals, Inc.: Equity Ownership, Other: Former employee. Shafner:Alexion Pharmaceuticals, Inc.: Employment, Equity Ownership. Damokosh:Alexion Pharmaceuticals, Inc.: Employment, Equity Ownership. Ortiz:Alexion Pharmaceuticals, Inc.: Employment, Equity Ownership. Röth:Pfizer: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria, Research Funding; Bioverativ: Consultancy, Honoraria; Amgen: Research Funding. Peffault De Latour:Pfizer Inc.: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria, Research Funding; Amgen Inc.: Research Funding.
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Kulasekararaj, Austin, Anita Hill, Saskia Langemeijer, Richard A. Wells, F. Ataulfo Gonzalez-Fernandez, Anna Gaya, Emilio Ojeda Gutierrez, et al. "One-Year Efficacy and Safety from a Phase 3 Trial of Ravulizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria Receiving Prior Eculizumab Treatment." Blood 134, Supplement_1 (November 13, 2019): 2231. http://dx.doi.org/10.1182/blood-2019-128746.
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INTRODUCTION Ravulizumab, an innovative long-acting C5 complement inhibitor, was recently approved in the United States, Europe, and Japan for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). In the largest phase 3 study (ALXN1210-PNH-302; NCT03056040) in eculizumab-experienced PNH patients (pts), ravulizumab (q8w) was shown to be noninferior to eculizumab (q2w) after 26 wks for all primary and key secondary endpoints. At the end of the 26-wk treatment period, all pts had the option to receive weight-based dosing of ravulizumab in an extension for up to 2 y. We report on the efficacy and safety of ravulizumab through 52 wks of treatment. METHODS This was an extension of the open-label, phase 3, multicenter study described above. Adult PNH pts who were stable on eculizumab for ≥6 mo and with lactate dehydrogenase (LDH) of ≤1.5xULN at screening were randomly assigned 1:1 to switch to ravulizumab or continue receiving eculizumab for 26 wks. After 26 wks, pts in the ravulizumab arm continued ravulizumab maintenance therapy (R-R arm), and pts in the eculizumab arm were switched to ravulizumab (E-R arm). For the 52-wk data, the primary efficacy endpoint was percent change in LDH from baseline (BL), and key secondary endpoints included the proportion of pts with breakthrough hemolysis (BTH), transfusion avoidance, improvement in FACIT-Fatigue total score, and stabilized hemoglobin (HGB-S) levels. Additional endpoints included change in plasma free C5 levels from BL and safety evaluations. RESULTS Of the 192 pts who received ravulizumab during the study, 191 entered the extension period (R-R arm: n=96; E-R arm: n=95). Pts in both groups showed a durable response for percentage change in LDH up to 52 wks, similar to what was observed during the first 26 wks (Figure A). At 52 wks, pts in the R-R arm had an 8.8% increase in LDH from baseline (standard deviation [SD], 29%), while pts in the E-R arm had 5.8% (SD, 27%) change in LDH from baseline. Mean LDH levels in both groups were maintained at 1.0xULN (<246 U/L). The proportion of pts who experienced BTH was low and stable over the 52-wk treatment with ravulizumab (Table). During wks 0-26, no pts in the R-R arm experienced BTH vs 3 during wks 27-52. In the E-R arm, 5 pts experienced BTH during wks 0-26 vs 1 in wks 27-52 after switching to ravulizumab. During wks 27-52, no BTH events were associated with free C5 of ≥0.5 μg/mL (threshold for complete C5 inhibition). The percentage of pts avoiding transfusion remained stable in the extension period (Table). During wks 0-26, 88% of pts in the R-R arm avoided transfusion vs 87% in wks 27-52; in the E-R arm, 83% (0-26 wks) vs 83% (27-52 wks) avoided transfusion. FACIT-Fatigue scores were maintained in both treatment groups through 52 wks. The proportion of pts with HGB-S was 76% in each arm during wks 0-26, and 81% in each arm during wks 27-52. All pts in the R-R arm continued to maintain free C5 of <0.5 μg/mL at all time points through 52 wks (n=96; Figure B). All pts in the ravulizumab treatment group continued to maintain free C5 of <0.5 μg/mL at all time points through 52 wks (n=96). In pts initially randomized to eculizumab, the switch to ravulizumab showed improved free C5 control, and no pts had free C5 of ≥0.5 µg/mL after the switch. During the extension, 79% in the R-R arm experienced a treatment-emergent adverse event (TEAE) vs 75% in the E-R arm. The most frequently reported TEAEs in the R-R arm were upper respiratory tract infection (URTI; 9 pts [9%]), and headache and nasopharyngitis (6 pts [6%] each). The most common TEAEs in the E-R arm were headache (10 pts [10%]), URTI (8 pts [8%]), and nasopharyngitis (7 pts [7%]). Eight pts (8%) in the R-R arm and 5 pts (5%) in the E-R arm experienced serious AEs; none led to discontinuation or death. No new treatment-emergent antidrug antibody-positive responses were reported during wks 27-52. There were no meningococcal infections, deaths, or discontinuations due to AEs. CONCLUSIONS Adult PNH pts receiving stable eculizumab therapy who received ravulizumab over 52 wks experienced durable efficacy; pts who received eculizumab for 26 wks and then switched to ravulizumab had an efficacy response consistent with pts in the R-R arm. All pts who had suboptimal free C5 control receiving eculizumab achieved complete free C5 inhibition after the switch to ravulizumab; no BTH events were associated with free C5 levels of ≥0.5 μg/mL. Ravulizumab continues to be well tolerated through wk 52 with no new safety concerns. Disclosures Kulasekararaj: Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Achilleon: Consultancy; Ra Pharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Akari Therapeutics: Consultancy; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Alexion: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Hill:Akari: Honoraria; Alexion: Honoraria; Bioverativ: Honoraria; Apellis: Honoraria; Novartis: Honoraria; Regeneron: Honoraria; Roche: Honoraria; Ra Pharma: Honoraria. Wells:Alexion: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Novartis: Honoraria, Research Funding. Gonzalez-Fernandez:Alexion: Research Funding, Speakers Bureau. Gaya:Alexion: Honoraria, Membership on an entity's Board of Directors or advisory committees; MSD: Honoraria; Novartis: Honoraria. Piatek:Alexion: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Dova: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Rigel: Honoraria, Membership on an entity's Board of Directors or advisory committees; Incyte: Research Funding. Mitchell:Novartis: Honoraria; Alexion: Honoraria. Usuki:Alexion: Honoraria, Speakers Bureau. Brodsky:Achillion: Research Funding; Alexion: Membership on an entity's Board of Directors or advisory committees, Other: Grant funding. Ogawa:Alexion Pharmaceuticals: Employment, Equity Ownership. Ortiz:Alexion: Employment. Röth:Alexion: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bioverativ: Consultancy, Honoraria; Apellis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Lee:Alexion: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Achillion: Research Funding. Peffault de Latour:Alexion: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Amgen: Research Funding; Pfizer: Consultancy, Honoraria, Research Funding.
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Ceyhan, Mehmet, Yasemin Ozsurekci, Sevgen Tanır Basaranoglu, Nezahat Gurler, Enes Sali, Melike Keser Emiroglu, Fatma Nur Oz, et al. "Multicenter Hospital-Based Prospective Surveillance Study of Bacterial Agents Causing Meningitis and Seroprevalence of Different Serogroups of Neisseria meningitidis, Haemophilus influenzae Type b, and Streptococcus pneumoniae during 2015 to 2018 in Turkey." mSphere 5, no. 2 (March 25, 2020). http://dx.doi.org/10.1128/msphere.00060-20.
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ABSTRACT The etiology of bacterial meningitis in Turkey changed after the implementation of conjugated vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) in the Turkish National Immunization Program (NIP). Administration of Hib vaccine and PCV-7 (7-valent pneumococcal conjugate vaccine) was implemented in NIP in 2006 and 2009, respectively. In 2011, PCV-7 was replaced with PCV-13. Meningococcal vaccines have not yet been included in Turkish NIP. This prospective study comprised 27 hospitals located in seven regions of Turkey and represented 45% of the population. Children aged between 1 month and 18 years who were hospitalized with suspected meningitis were included. Cerebrospinal fluid (CSF) samples were collected, and bacterial identification was made according to the multiplex PCR assay results. During the study period, 994 children were hospitalized for suspected meningitis, and Hib (n = 3, 2.4%), S. pneumoniae (n = 33, 26.4%), and Neisseria meningitidis (n = 89, 71%) were detected in 125 samples. The most common meningococcal serogroup was MenB. Serogroup W comprised 13.9% (n = 5) and 7.5% (n = 4) of the meningococci in 2015 to 2016 and 2017 to 2018, respectively. Serogroup C was not detected. There were four deaths in the study; one was a pneumococcus case, and the others were serogroup B meningococcus cases. The epidemiology of meningococcal diseases has varied over time in Turkey. Differing from the previous surveillance periods, MenB was the most common serogroup in the 2015-to-2018 period. Meningococcal epidemiology is so dynamic that, for vaccination policies, close monitoring is crucial. IMPORTANCE Acute bacterial meningitis (ABM) is one of the most common life-threatening infections in children. The incidence and prevalence of ABM vary both geographically and temporally; therefore, surveillance systems are necessary to determine the accurate burden of ABM. The Turkish Meningitis Surveillance Group has been performing a hospital-based meningitis surveillance study since 2005 across several regions in Turkey. Meningococcus was the major ABM-causing agent during the 2015-to-2018 period, during which MenB was the dominant serogroup.
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Dhingra, M. S., L. Namazova-Baranova, J. L. Arredondo-Garcia, K. H. Kim, K. Limkittikul, W. Jantarabenjakul, O. Perminova, et al. "Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study." Epidemiology and Infection 149 (2021). http://dx.doi.org/10.1017/s0950268821000698.
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Abstract Invasive meningococcal disease has high morbidity and mortality, with infants and young children among those at greatest risk. This phase III, open-label, randomised study in toddlers aged 12–23 months evaluated the immunogenicity and safety of meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT), a tetanus toxoid conjugated vaccine against meningococcal serogroups A, C, W and Y, when coadministered with paediatric vaccines (measles, mumps and rubella [MMR]; varicella [V]; 6-in-1 combination vaccine against diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b [DTaP-IPV-HepB-Hib] and pneumococcal conjugate vaccine [PCV13])(NCT03205371). Immunogenicity to each meningococcal serogroup was assessed by serum bactericidal antibody assay using human complement (hSBA). Vaccine safety profiles were described up to 30 days post-vaccination. A total of 1183 participants were enrolled. The proportion with seroprotection (hSBA ≥1:8) to each meningococcal serogroup at Day 30 was comparable between the MenACYW-TT and MenACYW-TT + MMR + V groups (≥92 and ≥96%, respectively), between the MenACYW-TT and MenACYW-TT + DTaP-IPV-HepB-Hib groups (≥90% for both) and between the MenACYW-TT and MenACYW-TT + PCV13 groups (≥91 and ≥84%, respectively). The safety profiles of MenACYW-TT, and MMR + V, DTaP-IPV-HepB-Hib, and PCV13, with or without MenACYW-TT, were generally comparable. Coadministration of MenACYW-TT with paediatric vaccines in toddlers had no clinically relevant effect on the immunogenicity and safety of any of the vaccines.
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"Clozapine/hib-meningococcal-vaccine-group-C-conjugate/pneumococcal-vaccine." Reactions Weekly 1824, no. 1 (October 2020): 99–100. http://dx.doi.org/10.1007/s40278-020-84067-3.
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"Hib-meningococcal-vaccine-group-C-conjugate/measles-mumps-and-rubella-virus-vaccine." Reactions Weekly 1850, no. 1 (April 2021): 153. http://dx.doi.org/10.1007/s40278-021-93958-6.
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"Hib meningococcal vaccine group-c conjugate/measles mumps and rubella virus vaccine (priorix)." Reactions Weekly 1861, no. 1 (June 2021): 150. http://dx.doi.org/10.1007/s40278-021-97950-7.
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Lévy-Bruhl, Daniel, Jean-Claude Desenclos, Sylvie Quelet, and François Bourdillon. "Extension of French vaccination mandates: from the recommendation of the Steering Committee of the Citizen Consultation on Vaccination to the law." Eurosurveillance 23, no. 17 (April 26, 2018). http://dx.doi.org/10.2807/1560-7917.es.2018.23.17.18-00048.
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On 4 December 2017, French parliamentarians passed a law extending the vaccination mandates for children up to 2 years of age from three vaccinations (against diphtheria, tetanus and poliomyelitis) to 11 by adding vaccinations against pertussis, Haemophilus influenza b (Hib), hepatitis B, pneumococcal diseases, meningococcal C diseases, measles, mumps and rubella. This vote follows a recommendation made by the Steering Committee of the Citizen Consultation on Vaccination that took place in 2016. The law applies to all children born after 1 January 2018. Parents who do not fulfil the mandate will not be fined but non-vaccinated children will not be admitted to any collective child services such as nurseries or schools. No exemption other than for medical reasons will be considered. Here we describe the historical background of this evolution and its main epidemiological, sociological and policy drivers. They mainly refer to insufficient vaccine coverage, persistence of a preventable burden for some diseases and growing vaccine hesitancy in the French population. We also discuss some of the challenges and conditions of success.
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Martins, L., N. Cunha, C. Baebieri, Y. Pamplona, N. Loureiro, R. Olinda, and L. Moschini. "Spatial analysis of vaccination coverage in Paraíba in 2016." European Journal of Public Health 30, Supplement_5 (September 1, 2020). http://dx.doi.org/10.1093/eurpub/ckaa165.869.
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Abstract Introduction Immunization is a human right, being considered an action of the most successful and cost-effective in public health. In Brazil, it is an action that is linked to primary health care, In Brazil, the National Immunization Program (PNI), created in 1973, is recognized as a world reference of public health policy, as it offers all vaccines recommended by the World Organization health care in its national vaccination calendar. Objective Spatial analysis of vaccination coverage of children aged 0 to 11 months in Paraíba in 2016. Methods Cross-sectional study, with information on doses applied to children under 1 year of age obtained at the PNI, by municipality of Paraíba. Live birth data from the Live Birth information system (SINASC). Descriptive analysis, chi-square test, spatial analysis. Results In Paraíba, 54.3% of the municipalities had adequate vaccination coverage, for BCG we have 68%, Hepatitis B (34.5%), Hib and DTP (35%), Polio (29.6%), pneumococcal (46.6%) and meningococcal (42.6%). The sertão paraibano is the mesoregion with the largest number of municipalities in the state with adequate vaccination coverage (p < 0.01), the paraiba forest is the region with the highest number of municipalities with very low coverage (p < 0.01). Conclusions Thus, Paraíba does not present a homogeneous vaccination coverage, not having 'herd immunity'. This fact leaves the state vulnerable to the return of immunopreventable diseases and thus at risk of raising infant morbidity and mortality, constituting an important public health problem. Key messages Immunization is a human right, being considered an action of the most successful and cost-effective in public health. Paraíba does not present a homogeneous vaccination coverage, not having 'herd immunity'.