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Published: 10 December 2022
Last updated: 14 March 2023

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1

Gönüllü, Erdem, Burcu Topçu, Naci Öner, Ahmet Soysal, and Metin Karaböcüoğlu. "Fever-Associated Supraventricular Tachycardia after 4CMenB Vaccination in an Infant." Case Reports in Pediatrics 2019 (September 22, 2019): 1–3. http://dx.doi.org/10.1155/2019/4591964.

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Meningococcal serogroup B vaccine 4CMenB (Bexsero) is a new four-component protein vaccine developed to prevent Neisseria meningitidis serogroup B infections. Case. We report a girl with fever and supraventricular tachycardia (SVT) 6–8 hours after the second dose of 4CMenB. SVT was unresponsive to the first dose of adenosine but terminated after the fourth dose of adenosine. During three months of follow-up, she was free of further SVT attacks. Conclusion. This is the first report of ECG-proven SVT after 4CMenB vaccination. Even if fever is coexistent, SVT should be considered after persistent tachycardia and 4CMenB vaccination.
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Kent, Alison, Kazim Beebeejaun, Serena Braccio, Seilesh Kadambari, Paul Clarke, Paul T. Heath, and Shamez Ladhani. "Safety of meningococcal group B vaccination in hospitalised premature infants." Archives of Disease in Childhood - Fetal and Neonatal Edition 104, no. 2 (April 10, 2018): F171—F175. http://dx.doi.org/10.1136/archdischild-2017-314152.

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ObjectivesTo assess the risk of significant adverse events in premature infants receiving the novel 4-component group B meningococcal vaccine (4CMenB) with their routine immunisations at 2 months of age.Participants, design and settingIn December 2015, Public Health England requested neonatal units across England to voluntarily participate in a national audit; 19 units agreed to participate. Anonymised questionnaires were completed for infants receiving 4CMenB alongside their routine immunisations. For comparison, a historical cohort of premature infants receiving their primary immunisations without 4CMenB or paracetamol prophylaxis was used.Main outcome measuresParacetamol use; temperature, cardiovascular, respiratory and neurological status before and after vaccination; and management and investigations postvaccination, including serum C reactive protein levels, infection screens and antibiotic use.ResultsComplete questionnaires were returned for 133 premature infants (<35 weeks’ gestation) who received their first dose of 4CMenB at 8 weeks of age, including 108 who received prophylactic paracetamol according to national recommendations. Overall, 7% (8/108) of infants receiving 4CMenB with paracetamol had fever (>38°C) after vaccination compared with 20% (5/25) of those receiving 4CMenB without paracetamol (P=0.06) and none of those in the historical cohort. There were no significant differences between cohorts in the proportion of infants with apnoea, bradycardia, desaturation and receiving respiratory support after vaccination.Conclusions4CMenB does not increase the risk of serious adverse events in hospitalised premature infants. This audit supports the current national recommendations to offer 4CMenB with other routine vaccinations and prophylactic paracetamol to premature infants at their chronological age.
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Marshall, Helen S., Prabha H. Andraweera, James Ward, John Kaldor, Ross Andrews, Kristine Macartney, Peter Richmond, et al. "An Observational Study to Assess the Effectiveness of 4CMenB against Meningococcal Disease and Carriage and Gonorrhea in Adolescents in the Northern Territory, Australia—Study Protocol." Vaccines 10, no. 2 (February 16, 2022): 309. http://dx.doi.org/10.3390/vaccines10020309.

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Invasive meningococcal disease (IMD) causes significant morbidity and mortality worldwide with serogroup B being the predominant serogroup in Australia and other countries for the past few decades. The licensed 4CMenB vaccine is effective in preventing meningococcal B disease. Emerging evidence suggests that although 4CMenB impact on carriage is limited, it may be effective against gonorrhoea due to genetic similarities between Neisseria meningitidis and Neisseria gonorrhoeae. This study protocol describes an observational study that will assess the effect of the 4CMenB vaccine against meningococcal carriage, IMD and gonorrhoea among adolescents in the Northern Territory (NT). All 14–19-year-olds residing in the NT with no contraindication for 4CMenB vaccine will be eligible to participate in this cohort study. Following consent, two doses of 4CMenB vaccine will be administered two months apart. An oropharyngeal swab will be collected at baseline and 12 months to detect pharyngeal carriage of Neisseria meningitidis by PCR. The main methodological approaches to assess the effect of 4CMenB involve a nested case control analysis and screening method to assess vaccine effectiveness and an Interrupted Time Series regression analysis to assess vaccine impact. Research ethics approvals have been obtained from Menzies and Central Australian Human Research Ethics Committees and the Western Australian Aboriginal Health Ethics Committee. Results will be provided in culturally appropriate formats for NT remote and regional communities and published in international peer reviewed journals. ClinicalTrials.gov Identifier: NCT04398849.
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Yamashiro, Hirotaka, Nora Cutcliffe, Simon Dobson, David Fisman, and Ronald Gold. "The Role of Pediatricians as Key Stakeholders in Influencing Immunization Policy Decisions for the Introduction of Meningitis B Vaccine in Canada: The Ontario Perspective." Canadian Journal of Infectious Diseases and Medical Microbiology 26, no. 4 (2015): 183–90. http://dx.doi.org/10.1155/2015/963940.

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As key stakeholders in immunization policy decisions, the Pediatricians of Ontario held an accredited conference on January 18, 2014, to discuss prevention of invasive meningococcal disease. Five key recommendations were put forth regarding immunization strategies to protect children from meningococcal serogroup B disease. The recently approved four-component meningococcal B (4CMenB) vaccine should be recommended and funded as part of Ontario’s routine immunization schedule and should also be mandated for school attendance. Public funding for 4CMenB immunization is justified based on current MenB epidemiology, vaccine coverage, cost effectiveness and acceptability, as well as legal, political and ethical considerations related to 4CMenB immunization, particularly because routine recommendations and funding are currently in place for vaccination against meningococcal serogroups that cause significantly less disease in Canada than MenB. Broadly, the goals are to assist individual practitioners in advocating the benefits of 4CMenB vaccination to parents, and to counterbalance recommendations from the National Advisory Committee on Immunization and the Canadian Paediatric Society.
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5

Kimura, Alan, Daniela Toneatto, Annett Kleinschmidt, Huajun Wang, and Peter Dull. "Immunogenicity and Safety of a Multicomponent Meningococcal Serogroup B Vaccine and a Quadrivalent Meningococcal CRM197Conjugate Vaccine against Serogroups A, C, W-135, and Y in Adults Who Are at Increased Risk for Occupational Exposure to Meningococcal Isolates." Clinical and Vaccine Immunology 18, no. 3 (December 22, 2010): 483–86. http://dx.doi.org/10.1128/cvi.00304-10.

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ABSTRACTLaboratory staff who work with meningococcal isolates are at increased risk for developing invasive disease relative to the general population. This was the first study of laboratory workers who received both a conjugate vaccine against meningococcal serogroups A, C, W-135, and Y (Men ACWY-CRM, Menveo) and an investigational multicomponent vaccine against serogroup B containing factor H binding protein, neisserial adhesin A,Neisseriaheparin binding antigen, and New Zealand strain outer membrane vesicles (4CMenB). Healthy adults (18 to 50 years of age) received three doses of 4CMenB at baseline, 2 months, and 6 months followed by a single dose of MenACWY-CRM 1 month later. Immunogenicity was assessed via serum bactericidal assay using human complement (hSBA) at 1 month postvaccination; solicited reactogenicity and adverse events were monitored. Fifty-four participants enrolled. Bactericidal immune responses were evident after each dose of 4CMenB, as assessed by hSBA geometric mean titers and percentages of subjects with hSBA titers of ≥4 against the test strains or a 4-fold rise in titer over baseline. At 1 month postvaccination, most MenACWY-CRM recipients had hSBA titers of ≥8 against serogroups A, C, W-135, and Y. Few participants discontinued due to an adverse event or vaccine reaction. Rates of solicited reactions were lower after MenACWY-CRM than after 4CMenB administration. Sequential administration of 4CMenB and MenACWY-CRM provided robust evidence of an immune response against serogroups A, B, C, W-135, and Y in laboratory workers routinely exposed to meningococcal isolates.
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6

Isitt, Catherine, Catherine A. Cosgrove, Mary Elizabeth Ramsay, and Shamez N. Ladhani. "Success of 4CMenB in preventing meningococcal disease: evidence from real-world experience." Archives of Disease in Childhood 105, no. 8 (February 6, 2020): 784–90. http://dx.doi.org/10.1136/archdischild-2019-318047.

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Meningococcal disease remains one of the most feared infectious diseases worldwide because of its sudden onset, rapid progression and high case fatality rates, while survivors are often left with severe long-term sequelae. Young children have the highest incidence of invasive meningococcal disease (IMD), and nearly all cases in the UK, as in most of Europe and many other industrialised countries, are due to group B meningococci (MenB). The licensure of a broad-coverage, recombinant protein-based MenB vaccine (4CMenB) in 2013 was, therefore, heralded a major breakthrough in the fight against IMD. This vaccine was, however, licensed on immunogenicity and reactogenicity studies only, raising uncertainties about field effectiveness, long-term safety and antibody persistence. In 2015, the UK became the first country to implement 4CMenB into the national infant immunisation schedule and, since then, several countries have followed suit. Seven years after licensure, a wealth of real-world data has emerged to confirm 4CMenB effectiveness, along with large-scale safety data, duration of protection in different age groups, successful strategies to reduce vaccine reactogenicity, impact on carriage in adolescents and the potential for 4CMenB to protect against other meningococcal serogroups and against gonorrhoea. A number of questions, however, remain unanswered, including the investigation and management of vaccine-associated fever in infants, as well as disease severity and assessment of breakthrough cases in immunised children. Increasing use of 4CMenB will provide answers in due course. We now have vaccines against all the major serogroups causing IMD worldwide. Next-generation and combination vaccines against multiple serogroups look very promising.
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Lucidarme, Jay, Stefanie Gilchrist, Lynne S. Newbold, Stephen J. Gray, Edward B. Kaczmarski, Lynne Richardson, Julia S. Bennett, Martin C. J. Maiden, Jamie Findlow, and Ray Borrow. "Genetic Distribution of Noncapsular Meningococcal Group B Vaccine Antigens in Neisseria lactamica." Clinical and Vaccine Immunology 20, no. 9 (June 26, 2013): 1360–69. http://dx.doi.org/10.1128/cvi.00090-13.

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ABSTRACTThe poor immunogenicity of the meningococcal serogroup B (MenB) capsule has led to the development of vaccines targeting subcapsular antigens, in particular the immunodominant and diverse outer membrane porin, PorA. These vaccines are largely strain specific; however, they offer limited protection against the diverse MenB-associated diseases observed in many industrialized nations. To broaden the scope of its protection, the multicomponent vaccine (4CMenB) incorporates a PorA-containing outer membrane vesicle (OMV) alongside relatively conserved recombinant protein components, including factor H-binding protein (fHbp),Neisseriaadhesin A (NadA), and neisserial heparin-binding antigen (NHBA). The expression of PorA is unique to meningococci (Neisseria meningitidis); however, many subcapsular antigens are shared with nonpathogenic members of the genusNeisseriathat also inhabit the nasopharynx. These organisms may elicit cross-protective immunity against meningococci and/or occupy a niche that might otherwise accommodate pathogens. The potential for 4CMenB responses to impact such species (and vice versa) was investigated by determining the genetic distribution of the primary 4CMenB antigens among diverse members of the common childhood commensal,Neisseria lactamica. All the isolates possessednhbabut were devoid offhbpandnadA. Thenhbaalleles were mainly distinct from but closely related to those observed among a representative panel of invasive MenB isolates from the same broad geographic region. We made similar findings for the immunogenic typing antigen, FetA, which constitutes a major part of the 4CMenB OMV. Thus, 4CMenB vaccine responses may impact or be impacted by nasopharyngeal carriage of commensal neisseriae. This highlights an area for further research and surveillance should the vaccine be routinely implemented.
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Nolan, Terry, Hartley Garfield, Anil Gupta, Murdo Ferguson, Helen Marshall, Diego D’Agostino, and Daniela Toneatto. "Persistence of Bactericidal Activity at 4 Years After 2 Primary Doses of a Recombinant, 4-Component, Meningococcal Serogroup B Vaccine (4CMenB) and Response to a Booster Dose in Adolescents and Young Adults." Open Forum Infectious Diseases 4, suppl_1 (2017): S322. http://dx.doi.org/10.1093/ofid/ofx163.757.

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Abstract Background This phase 3b, open label, controlled, multi-center, extension study (NCT02446743) assessed the persistence of bactericidal activity at 4 years post-primary vaccination with a recombinant, 4-component, meningococcal serogroup B vaccine (4CMenB) in adolescents who participated in the parent study NCT01423084 and their response to a booster dose, compared with that in vaccine-naïve healthy controls. Methods Adolescents and young adults previously primed with 4CMenB (2 doses; following a 0,1-month schedule) in study NCT01423084 (group 3B) and vaccine-naïve 15–22 year olds (group B0_1) were enrolled. Group 3B received a booster dose of 4CMenB at 4 years post-primary vaccination; group B0_1 received 2 catch-up doses of 4CMenB (following a 0,1-month schedule). Antibody persistence (primary objective) was evaluated at 4 years post-primary vaccination (in group 3B) vs. baseline (in group B0_1) using human serum bactericidal assay (hSBA), in terms of geometric mean titer (GMT) and percentage (%) of individuals with hSBA titer at least 4. Immune responses at 1 month after booster dose (in group 3B) vs. those at 1 month after first dose (in group B0_1) were also assessed. Results In group 3B, antibody levels declined from 1 month to 4 years post-primary vaccination against all antigens except NHBA, but were higher than in group B0_1 at baseline (Table), with a GMT ratio ≥1.3 and a difference in % of individuals with hSBA titer at least 4 of ≥9%. After one dose of 4CMenB (booster in 3B or first dose in B0_1), GMTs increased (≥4.6-fold in group 3B; ≥2.3-fold in group B0_1), and ≥94% of participants in group 3B and ≥41% of participants in group B0_1 had hSBA titer at least 4 (Table). Conclusion Antibody levels in adolescents and young adults primed with 4CMenB waned over time but were higher at 4 years post-primary vaccination than for vaccine-naïve individuals at baseline. A booster dose of 4CMenB in vaccine-primed individuals elicited higher immune responses than one dose of 4CMenB in vaccine-naïve individuals. The research was supported by GlaxoSmithKline Biologicals SA. Disclosures T. Nolan, GSK group of companies: Research Contractor and Scientific Advisor, Research grant. Pfizer: Research Contractor, Research grant. H. Garfield, Novartis/GSK group of companies: Investigator, Research support. A. Gupta, Novartis/GSK group of companies: Investigator, payment for research-related activities; M. Ferguson, GSK group of companies: Investigator, I receive salary from CRG. CRG has contracts with GSK. H. Marshall, GSK group of companies: Grant Investigator and Investigator, Research grant. Pfizer: Grant Investigator and Investigator, Research grant; sanofi pasteur: Grant Investigator, Research grant. Novavax: Investigator, Research grant. D. D’Agostino, GSK group of companies: Consultant, Consulting fee. D. Toneatto, GSK group of companies: Employee, Salary.
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Azzari, Chiara, Maria Moriondo, Francesco Nieddu, Valentina Guarnieri, Lorenzo Lodi, Clementina Canessa, Giuseppe Indolfi, et al. "Effectiveness and Impact of the 4CMenB Vaccine against Group B Meningococcal Disease in Two Italian Regions Using Different Vaccination Schedules: A Five-Year Retrospective Observational Study (2014–2018)." Vaccines 8, no. 3 (August 22, 2020): 469. http://dx.doi.org/10.3390/vaccines8030469.

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Background: A few years after the introduction in Italy of a four-component anti-meningococcal B vaccine (4CMenB), we evaluated the effectiveness and impact of vaccination in two regions using different schedules (2, 4, 6, 12 months in Tuscany vs. 7, 9, 15 months in Veneto) through an observational retrospective study. Methods: Vaccination started in 2014 in Tuscany and in 2015 in Veneto; the data collected referred to the period 2006–2018 for Tuscany and 2007–2018 for Veneto. Cases of invasive meningococcal disease due to N. Meningitidis B were identified by culture and/or real-time PCR. Results: In Tuscany, pre-vaccine incidence was 1.96 (95% CL 1.52; 2.40) and dropped to 0.62 (95% CL 0.60; 0.64) in the post-4CMenB era. Evaluating only vaccinated children, post-4CMenB incidence was 0.12 (95% CL 0.08; 0.15). In Veneto pre-vaccine incidence was 1.94 (95% CL 1.92; 1.96) and dropped to 1.34 (95% CL 1.31; 1.38) in the post-4CMenB era. In the vaccinated population, MenB incidence was 0.53 (95% CL 0.50; 0.56). Vaccine effectiveness was 93.6% (95% CL 55.4; 99.1) in Tuscany and 91.0% (95% CL 59.9; 97.9) in Veneto, with mean vaccine coverages of 83.9% and 81.7%, respectively. The overall impact (evaluating both vaccinated and unvaccinated children) was 0.68 (95% CL 0.10; 0.89) in Tuscany and 0.31 (95% CL −0.56; 0.69) in Veneto; the total impact (evaluating only vaccinated children) was 0.94 (95% CL 0.56; 0.99) and 0.90 (95% CL 0.57; 0.97), respectively. The relative case reduction (RCR) was 65% in Tuscany and 31% in Veneto. Considering the vaccinated population, the RCR was equal to 91% and 80%, respectively. Conclusion: In conclusion, 4CMenB appears to have a very high effectiveness in Italy; the impact of vaccination appears greater where the immunization program is started early.
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Soler-Garcia, Aleix, Mariona Fernández de Sevilla, Raquel Abad, Cristina Esteva, Laia Alsina, Julio Vázquez, Carmen Muñoz-Almagro, and Antoni Noguera-Julian. "Meningococcal Serogroup B Disease in Vaccinated Children." Journal of the Pediatric Infectious Diseases Society 9, no. 4 (October 21, 2019): 454–59. http://dx.doi.org/10.1093/jpids/piz071.

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Abstract Background Neisseria meningitidis serogroup B (MenB) is the most frequent cause of invasive meningococcal disease (IMD) in Spain. The multicomponent vaccine against MenB (4CMenB) was approved in Spain in January 2014. Methods We present 4 cases of children who developed MenB-associated IMD despite previous vaccination with 4CMenB. Extensive immunologic diagnostic work-up was performed in order to rule out any immunodeficiency. Also, molecular characterization of the MenB strain was conducted to determine whether bacterial antigens matched vaccine antigens. Results Among the 4 patients (2 girls), 2 had previous risk factors for IMD (recurrent bacterial meningitis of unknown origin and treatment with eculizumab). All patients developed meningitis, but only 2 developed septic shock; they were all cured without sequelae. No other primary or secondary immunodeficiencies were detected. MenB sequence type 213 was identified in 3 cases. With the exception of neisserial heparin-binding antigen peptide 465 present in 1 isolate, the rest of the isolated strains harbored vaccine antigen variants that did not match antigen variants included in the vaccine. Conclusions We present 4 children who developed MenB-associated IMD despite previous vaccination with 4CMenB. In 2 cases, the antibodies induced by 4CMenB likely were not effective against the isolated strains. A high level of suspicion for IMD seems advisable regardless of the patient’s vaccination history.
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Ladhani, Shamez N., Ray Borrow, and Nick J. Andrews. "Growing evidence supports 4CMenB effectiveness." Lancet Infectious Diseases 18, no. 4 (April 2018): 370–71. http://dx.doi.org/10.1016/s1473-3099(18)30051-3.

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Nolan, Terry, Miguel O’Ryan, María Elena Santolaya, Ferdinandus De Looze, Helen Marshall, Peter Richmond, Sam Henein, et al. "152. Protective Antibody Levels 7.5 Years After Primary Vaccination in Adolescence With a Recombinant, 4-Component, Meningococcal Serogroup B Vaccine (4CMenB) and Response to a Booster Dose in Adolescents and Young Adults: Phase IIIb Clinical Findings." Open Forum Infectious Diseases 5, suppl_1 (November 2018): S11. http://dx.doi.org/10.1093/ofid/ofy209.022.

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Abstract Background 4CMenB has been shown to be immunogenic with an acceptable safety profile in infants and young adolescents. However, no data on long-term persistence after primary vaccination in adolescents are available. This is the first study to assess antibody persistence, booster response, and safety of 4CMenB in adolescents and young adults up to 7.5 years following the primary vaccination in adolescence. Methods This phase 3b, open-label, extension study (NCT02446743) assessed the antibody persistence and booster response at 4 years (Canada and Australia, NCT01423084) or 7.5 years (Chile, NCT00661713) after primary vaccination with 4CMenB (following 0 + 1-, 0 + 2-, or 0 + 6-month schedules), compared with vaccine-naïve (VN), healthy controls. Chilean follow-on (FO) and VN participants aged 18–24 years received either a booster dose of 4CMenB 7.5 years postprimary series (Group FO, N = 131) or 2 primary doses, 1 month apart (Group VN, N = 150). Immunogenicity was measured using human serum bactericidal antibody assay (hSBA) against antigen-specific strains. Immune response was evaluated 1 month post-booster vaccination and compared with VN controls at 1 month post-first dose. Kinetics of antibody responses were measured at 3, 7, and 30 days post-vaccination. Safety was assessed. Results Antibody levels waned at 7.5 years postprimary vaccination in Group FO, but were higher than in Group VN at baseline, for all antigens except NHBA (table). At 1 month post-booster/post-first dose, 93–100% (Group FO) and 62–93% (Group VN) of participants had hSBA titres ≥4; GMTs ranged between 41 and 1,951 (Group FO) and 9.43–46 (Group VN) (table). The percentages of FO participants with hSBA titres ≥4 remained similar to prebooster for all 4 antigens at 3 days, increased at 7 days, and remained unchanged or increased further 30 days post-booster. The reactogenicity of 4CMenB was consistent with previous observations in this age group; no safety concerns were identified during the study. Conclusion Antibody levels in adolescents and young adults declined at 7.5 years after a 2-dose primary series of 4CMenB, but were higher than baseline levels in VN controls. An additional dose of 4CMenB elicited strong anamnestic responses—substantially higher than 1 dose in VN controls. Funding: GlaxoSmithKline Biologicals SA. Disclosures T. Nolan, GSK: Research Contractor and Scientific Advisor, Research grant. Pfizer: Research Contractor, Research grant. M. O’Ryan, GSK: Investigator, Research support. F. De Looze, GSK: Investigator and Research Contractor, Research grant and Research support. H. Marshall, Pfizer: Grant Investigator and Investigator, Research grant. GSK: Grant Investigator and Investigator, Research grant. P. Richmond, GSK: Grant Investigator and Scientific Advisor, Grant recipient. S. Henein, SKDS Research Inc.: Investigator, Research payment. K. Heaton, Devonshire Clinical Research Inc.: Investigator, Research payment. M. Ferguson, GSK: Investigator, Salary from independent research clinic,CRG. D. D’Agostino, GSK: Employee, Salary. D. Toneatto, GSK: Employee and Shareholder, Salary.
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Ferrara, Pietro, Lucia Stromillo, and Luciana Albano. "Awareness, Attitudes, and Practices Toward Meningococcal B Vaccine among Pediatricians in Italy." Medicina 54, no. 6 (December 3, 2018): 100. http://dx.doi.org/10.3390/medicina54060100.

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Background and objectives: Vaccination against bacterial pathogens is decisive for preventing invasive meningococcal disease and pediatricians play a pivotal role in vaccination compliance and coverage. The aim of this study was to investigate awareness, attitude, and practices toward the vaccine against Meningococcal B serogroup (4CMenB) among a sample of Italian pediatricians. Materials and Methods: A cross-sectional study was carried out using an online questionnaire from March to May 2015. Three multivariate logistic regression models were built to identify factors associated with the outcomes of interest. Results: The data showed that 95.5% of the interviewees correctly responded about the availability of 4CMenB vaccine in Italy, while only 28.0% knew the vaccination schedule for children aged two years or under. This knowledge was significantly higher in younger pediatricians and in those who worked a higher number of hours per week. Pediatricians self-reported a positive attitude toward the utility and safety of 4CMenB vaccine. Those pediatricians with a strong positive attitude toward the utility of the vaccine, who knew the vaccination schedules for children of two years or under, and who declared a satisfactory or good knowledge about the vaccine were more likely to inform parents about its availability in Italy, recommend the vaccination, and verify patients’ vaccination status, in their daily practice. Conclusions: The study highlights factors that currently influence pediatricians’ practices regarding the 4CMenB vaccine. The results showed the possible actions recommended to improve physicians’ awareness and behaviors in order to improve the vaccination compliance and invasive meningococcal diseases prevention.
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Banzhoff, Angelika. "Multicomponent meningococcal B vaccination (4CMenB) of adolescents and college students in the United States." Therapeutic Advances in Vaccines 5, no. 1 (January 6, 2017): 3–14. http://dx.doi.org/10.1177/2051013616681365.

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Meningococcal disease is rare, easily misdiagnosed, and potentially deadly. Diagnosis in the early stages is difficult and the disease often progresses extremely rapidly. In North America, the incidence of invasive meningococcal disease (IMD) is highest in infants and young children, with a secondary peak in adolescents, a population predominantly responsible for the carriage of disease. Neisseria meningitidis serogroup B (MenB) accounts for a large proportion of meningococcal disease in North America, with documented outbreaks in three universities in the United States (US) during 2008–2013. Vaccination is the most effective way to protect against this aggressive disease that has a narrow timeframe for diagnosis and treatment. 4CMenB is a multi-component vaccine against MenB which contains four antigenic components. We describe in detail the immunogenicity and safety profile of 4CMenB based on results from four clinical trials; the use of 4CMenB to control MenB outbreaks involving vaccination at two US colleges during outbreaks in 2013–2014; and the use of 4CMenB in a Canadian mass vaccination campaign to control the spread of MenB disease. We discuss the reasons why adolescents should be vaccinated against MenB, by examining both the peak in disease incidence and carriage. We consider whether herd protection may be attained for MenB, by discussing published models and comparing with meningitis C (MenC) vaccines. In conclusion, MenB vaccines are now available in the US for people aged 10–25 years, representing an important opportunity to reduce the incidence of IMD in the country across the whole population, and more locally to combat MenB outbreaks.
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Marshall, Helen S., Mark McMillan, Ann Koehler, Andrew Lawrence, Jenny M. MacLennan, Martin C. J. Maiden, Mary Ramsay, et al. "B Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage ofNeisseria meningitidisin adolescents." BMJ Open 8, no. 7 (July 2018): e020988. http://dx.doi.org/10.1136/bmjopen-2017-020988.

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IntroductionSouth Australia (SA) has the highest notification rate of invasive meningococcal disease in Australia with the majority of cases due to serogroup B.Neisseria meningitidisis carried in the pharynx, with adolescents having the highest rates of carriage. A vaccine designed to offer protection against serogroup B (4CMenB) is licensed in Australia. The SA MenB vaccine carriage study aims to assess the impact of 4CMenB on carriage ofN. meningitidisin adolescents.Methods and analysisThis is a parallel cluster randomised controlled trial enrolling year 10, 11 and 12 school students (approximately 16–18 years of age) throughout SA, in metropolitan and rural/remote areas. Schools are randomised to intervention (4CMenB vaccination at baseline) or control (4CMenB vaccination at study completion) with randomisation stratified by school size and socioeconomic status, as measured by the Index of Community Socio-Educational Advantage (Australian Curriculum). Oropharyngeal swabs will be taken from all students at visit 1, and 12 months later from year 11 and 12 students. Students unvaccinated in 2017 will receive vaccine at the 12-month follow-up. Carriage prevalence ofN. meningitidiswill be determined by PCR at baseline and 12 months following 4CMenB vaccination and compared with carriage prevalence at 12 months in unvaccinated students. A questionnaire will be completed at baseline and 12 months to assess risk factors associated with carriage. The primary outcome of carriage prevalence of disease causingN. meningitidisat 12 months will be compared between groups using logistic regression, with generalised estimating equations used to account for clustering at the school level. The difference in carriage prevalence between groups will be expressed as an OR with 95% CI.Ethics and disseminationThe study was approved by the Women’s and Children’s Health Network Human Research Ethics Committee (WCHN HREC). The protocol, informed consent forms, recruitment materials, social media and all participant materials have been reviewed and approved by the WCHN HREC and updated on ClinicalTrials.gov. Results will be published in international peer-reviewed journals and presented at national and international conferences. The study findings will be provided in public forums and to study participants and participating schools.Trial registration numberACTRN12617000079347.NCT03089086; Pre-results.
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Zafack, Joseline Guetsop, Alexandre Bureau, Danuta M. Skowronski, and Gaston De Serres. "Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials." BMJ Open 9, no. 5 (May 17, 2019): e026953. http://dx.doi.org/10.1136/bmjopen-2018-026953.

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Objectives(1) To assess if co-administration of four-component meningococcal serogroup B vaccine (4CMenB) and other routine vaccines caused an interaction increasing the risk and/or severity of adverse events following immunisation (AEFI) compared with administration at separate visits and (2) to estimate the risk of AEFI recurrence.DesignRisk-interval designSettingThree randomised controlled trials conducted in Europe.ParticipantsA total of 5026 healthy 2-month-old to 15-month-old infants.Interventions4CMenB and routine vaccines (hexavalent combined diphtheria-tetanus-acellular pertussis-inactivated polio-Haemophilus influenzae type b-hepatitis B vaccine+seven-valent pneumococcal conjugate vaccine or measles-mumps-rubella-varicella vaccine) administered concomitantly or separately 1 month apart, in regular (2, 4, 6 and 12 months), accelerated (2, 3, 4 and 12 months) or delayed (two doses of 4CMenB at ≥12 months of age) schedules.Outcome measuresPrimary: Fever (≥38°C) during the first 48 hours post immunisation. Secondary: crying, change in eating habits, diarrhoea, irritability and tenderness at the 4CMenB injection site.ResultsCompared with separate administration, concomitant administration decreased the overall incidence of fever (≥38°C), 86% versus 75%, and other systemic AEFIs but increased the incidence of 4CMenB injection site tenderness, 55% versus 66%, moderate/severe fevers (≥39°C), 13% versus 18%, and long-lasting (>1 day) fevers, 23% versus 33%. Co-administration reduced AEFI risk by 4%–49% with the greatest impact among infants with prior AEFI(s). Fever recurrence risk was proportional to the number of prior fever events: 79% at dose 2 with one prior episode; 44% and 74% at dose 3 with one and two prior episodes, respectively; and 29%, 45% and 60% at dose 4 with one, two and three prior episodes, respectively. Severity was not increased at recurrence and a similar pattern of recurrence risk proportional to the number of prior events was observed for other AEFIs.ConclusionsThe cumulative risk of AEFI is reduced with concomitant versus separate administration of 4CMenB and routine infant vaccines. Infants with a prior AEFI are at higher risk of the same AEFI at subsequent immunisations, but severity with recurrence is usually not increased.Trials registration numberNCT00657709,NCT00847145,NCT00721396andNCT02712177; Pre-results.
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La Fauci, Vincenza, Daniela Lo Giudice, Raffaele Squeri, and Cristina Genovese. "Insight into Prevention of Neisseria Gonorrhoeae: A Short Review." Vaccines 10, no. 11 (November 18, 2022): 1949. http://dx.doi.org/10.3390/vaccines10111949.

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Neisseria gonorrhoeae (gonococcus) and Neisseria meningitidis (meningococcus) are important global pathogens which cause the sexually transmitted diseases gonorrhea and meningitis, respectively, as well as sepsis. We prepared a review according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA), with the aims of (a) evaluating the data on the MenB vaccination as protection against sexually transmitted infections by N. gonorrhoeae and (b) to briefly comment on the data of ongoing studies of new vaccines. We evaluated existing evidence on the effect of 4CMenB, a multi-component vaccine, on invasive diseases caused by different meningococcal serogroups and on gonorrhea. Non-B meningococcal serogroups showed that the 4CMenB vaccine could potentially offer some level of protection against non-B meningococcal serogroups and N. gonorrhoeae. The assessment of the potential protection conferred by 4CMenB is further challenged by the fact that further studies are still needed to fully understand natural immune responses against gonococcal infections. A further limitation could be the potential differences between the protection mechanisms against N. gonorrhoeae, which causes local infections, and the protection mechanisms against N. meningitidis, which causes systemic infections.
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Basta, Nicole E., and Hannah Christensen. "4CMenB vaccine effectiveness: reasons for optimism." Lancet 388, no. 10061 (December 2016): 2719–21. http://dx.doi.org/10.1016/s0140-6736(16)32061-x.

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Biolchi, Alessia, Sara Tomei, Laura Santini, Rita La Gaetana, Elena Mori, Patricia Novy, Rino Rappuoli, et al. "7. Two-Dose 4CMenB Vaccination in Adolescents Elicits a Bactericidal Activity against 15 Outbreak-Representative Meningococcal Strains." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S26. http://dx.doi.org/10.1093/ofid/ofaa439.052.

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Abstract Background Meningococcal outbreaks have often been associated with N. meningitidis serogroup B (MenB) in high-income countries. We examined whether antibodies elicited by the 4-component MenB vaccine (4CMenB) in adolescents could induce complement-mediated bacterial killing of a panel of 14 genetically diverse MenB strains representative of outbreaks that occurred from 2001 to 2016 (11 from the US, 2 from the UK, and 1 from France). One N. meningitidis serogroup W (MenW) hyperendemic strain (UK, 2011) was also included in the analysis. Methods In a previous multicenter study (NCT02212457), adolescents aged 10-18y received 2 4CMenB doses 2 months apart. We tested individual sera collected from a subgroup of 20 US participants at pre-vaccination and 1 month post-second dose in a serum bactericidal assay with human complement (hSBA) against the meningococcal strain panel. Similarly, sera collected from 23 Chilean adolescents aged 11-17y (NCT00661713) were tested in a hSBA against a subset of 4 strains (3 from the US, 1 from the UK). Results At baseline, the percentage of US subjects with seroprotective titers (hSBA ≥ 1:4) ranged from 5% to 35%. One month after 4CMenB series completion, 65% to 100% had seroprotective titers (hSBA ≥ 1:4) against 11 out of the 14 MenB tested strains. The seroprotection rate was 45%, 25%, and 15% against the 3 remaining MenB strains. Against MenW, the percentage of adolescents with hSBA titers ≥ 1:4 was 15% at baseline and 95% one month after series completion. No significant changes in the percentage of subjects were observed when analysing hSBA titers ≥ 1:8. Moreover, the subset analysis indicated similar results for US and Chilean subjects for 3 out of 4 strains: the percentage of US vs Chilean subjects with hSBA titers ≥ 1:4 was 100% vs 100%; 80% vs 74%; 45% vs 52%. For the 4th strain, 65% of US subjects vs 91% of Chilean subjects showed a hSBA ≥ 1:4. Conclusion 4CMenB elicited bactericidal antibodies against a panel of 14 outbreak-representative MenB strains and 1 MenW hyperendemic strain in US adolescents. No major differences were detected in the bactericidal activity of Chilean subjects vaccinated with 4CMenB when tested against a subset of 4 MenB outbreak strains, suggesting that the immune response to 4CMenB is comparable in adolescents from different geographic areas. Disclosures Alessia Biolchi, n/a, GSK (Employee) Sara Tomei, n/a, GSK (Employee) Laura Santini, n/a, GSK (Employee) Rita La Gaetana, n/a, GSK Vaccines (Employee, Shareholder) Elena Mori, n/a, GSK (Employee) Patricia Novy, PhD, GSK (Employee, Shareholder) Rino Rappuoli, PhD, GSK (Employee) Rafik Bekkat-Berkani, M.D, GSK (Employee, Shareholder) Marzia Monica Giuliani, n/a, GSK (Employee, Shareholder) Mariagrazia Pizza, Biological Sciences, PhD, GSK Vaccines (Employee)
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Leduc, Isabelle, Kristie L. Connolly, Afrin Begum, Knashka Underwood, Stephen Darnell, William M. Shafer, Jacqueline T. Balthazar, et al. "The serogroup B meningococcal outer membrane vesicle-based vaccine 4CMenB induces cross-species protection against Neisseria gonorrhoeae." PLOS Pathogens 16, no. 12 (December 8, 2020): e1008602. http://dx.doi.org/10.1371/journal.ppat.1008602.

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There is a pressing need for a gonorrhea vaccine due to the high disease burden associated with gonococcal infections globally and the rapid evolution of antibiotic resistance in Neisseria gonorrhoeae (Ng). Current gonorrhea vaccine research is in the stages of antigen discovery and the identification of protective immune responses, and no vaccine has been tested in clinical trials in over 30 years. Recently, however, it was reported in a retrospective case-control study that vaccination of humans with a serogroup B Neisseria meningitidis (Nm) outer membrane vesicle (OMV) vaccine (MeNZB) was associated with reduced rates of gonorrhea. Here we directly tested the hypothesis that Nm OMVs induce cross-protection against gonorrhea in a well-characterized female mouse model of Ng genital tract infection. We found that immunization with the licensed Nm OMV-based vaccine 4CMenB (Bexsero) significantly accelerated clearance and reduced the Ng bacterial burden compared to administration of alum or PBS. Serum IgG and vaginal IgA and IgG that cross-reacted with Ng OMVs were induced by 4CMenB vaccination by either the subcutaneous or intraperitoneal routes. Antibodies from vaccinated mice recognized several Ng surface proteins, including PilQ, BamA, MtrE, NHBA (known to be recognized by humans), PorB, and Opa. Immune sera from both mice and humans recognized Ng PilQ and several proteins of similar apparent molecular weight, but MtrE was only recognized by mouse serum. Pooled sera from 4CMenB-immunized mice showed a 4-fold increase in serum bactericidal50 titers against the challenge strain; in contrast, no significant difference in bactericidal activity was detected when sera from 4CMenB-immunized and unimmunized subjects were compared. Our findings directly support epidemiological evidence that Nm OMVs confer cross-species protection against gonorrhea, and implicate several Ng surface antigens as potentially protective targets. Additionally, this study further defines the usefulness of murine infection model as a relevant experimental system for gonorrhea vaccine development.
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Domnich, Alexander, Roberto Gasparini, Daniela Amicizia, Giuseppe Boccadifuoco, Marzia Monica Giuliani, and Donatella Panatto. "Meningococcal Antigen Typing System Development and Application to the Evaluation of Effectiveness of Meningococcal B Vaccine and Possible Use for Other Purposes." Journal of Immunology Research 2015 (2015): 1–9. http://dx.doi.org/10.1155/2015/353461.

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Development of the 4-component meningococcal serogroup B vaccine (4CMenB) has required new assays for the reliable evaluation of the expression and cross-reactivity of those specific antigen variants that are predicted to be targeted by bactericidal antibodies elicited by the vaccine in different isolates. Existing laboratory techniques, such as multilocus sequence typing, are poorly suited to this purpose, since they do not provide information on the contribution of single vaccine components and therefore cannot be applied to estimate the potential coverage of the multicomponent vaccine. The hSBA, the only correlate of protection against invasive meningococcal disease accepted thus far, cannot conveniently be used to test large number of strains. To overcome these issues, the meningococcal antigen typing system (MATS) has been specifically developed in order to predict 4CMenB coverage of individual meningococcus serogroup B strains. To date, MATS has proved advantageous for several reasons, including its ability to assess both qualitative and quantitative aspects of surface antigens of single strains in a highly reproducible, rapid, and resource-saving manner, while its shortcomings include a possible underestimation of 4CMenB coverage and the use of pooled sera to calculate the positive bactericidal threshold. This paper provides an overview of MATS development and its field application.
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Taha, Muhamed-Kheir, and Ala-Eddine Deghmane. "Meningococcal carriage: the dilemma of 4CMenB vaccine." Lancet 384, no. 9960 (December 2014): 2088–90. http://dx.doi.org/10.1016/s0140-6736(14)60935-1.

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Fagnocchi, Luca, Alessia Biolchi, Francesca Ferlicca, Giuseppe Boccadifuoco, Brunella Brunelli, Sébastien Brier, Nathalie Norais, et al. "Transcriptional Regulation of thenadAGene in Neisseria meningitidis Impacts the Prediction of Coverage of a Multicomponent Meningococcal Serogroup B Vaccine." Infection and Immunity 81, no. 2 (December 10, 2012): 560–69. http://dx.doi.org/10.1128/iai.01085-12.

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ABSTRACTThe NadA adhesin is a major component of 4CMenB, a novel vaccine to prevent meningococcus serogroup B (MenB) infection. Underin vitrogrowth conditions,nadAis repressed by the regulator NadR and poorly expressed, resulting in inefficient killing of MenB strains by anti-NadA antibodies. Interestingly, sera from children infected with strains that express low levels of NadA in laboratory growth nevertheless recognize the NadA antigen, suggesting that NadA expression during infection may be different from that observedin vitro. In a strain panel covering a range of NadA levels, repression was relieved through deletingnadR. AllnadRknockout strains expressed high levels of NadA and were efficiently killed by sera from subjects immunized with 4CMenB. A selected MenB strain, NGP165, mismatched for other vaccine antigens, is not killed by sera from immunized infants when the strain is grownin vitro. However, in anin vivopassive protection model, the same sera effectively protected infant rats from bacteremia with NGP165. Furthermore, we identify a novel hydroxyphenylacetic acid (HPA) derivative, reported by others to be produced during inflammation, which induces expression of NadAin vitro, leading to efficient antibody-mediated killing. Finally, using bioluminescent reporters,nadAexpression in the infant rat model was inducedin vivoat 3 h postinfection. Our results suggest that during infectious disease, NadR repression is alleviated due to niche-specific signals, resulting in high levels of NadA expression from anynadA-positive (nadA+) strain and therefore efficient killing by anti-NadA antibodies elicited by the 4CMenB vaccine.
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Langereis, Jeroen D., Bryan van den Broek, Sjoerd Franssen, Irma Joosten, Nicole M. A. Blijlevens, Marien I. de Jonge, and Saskia Langemeijer. "Eculizumab impairs Neisseria meningitidis serogroup B killing in whole blood despite 4CMenB vaccination of PNH patients." Blood Advances 4, no. 15 (August 7, 2020): 3615–20. http://dx.doi.org/10.1182/bloodadvances.2020002497.

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Abstract Complement C5 inhibitor eculizumab has a great impact on the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). However, this treatment success has a major drawback: a substantially increased susceptibility for life-threatening Neisseria meningitidis infections. Therefore, N meningitidis vaccination is strongly advised before initiating complement C5–blocking therapy. In this study, we show that the multicomponent N meningitidis serogroup B (4CMenB) vaccination of PNH patients treated with eculizumab results in a significant increase in anti–N meningitidis serogroup B (MenB) plasma immunoglobulin G (IgG) levels. Anti-MenB IgG was able to bind to the bacterial surface and initiate complement activation; however, inhibition of the membrane attack complex formation completely blocked whole blood–mediated killing of MenB. This would suggest that, despite 4CMenB vaccination, PNH patients taking C5 inhibitors are not sufficiently protected against MenB infection, which is in line with the fact that vaccinated PNH patients still experience meningococcal infections.
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Dubé, Eve, Dominique Gagnon, Denis Hamel, Sylvie Belley, Hélène Gagné, Nicole Boulianne, Monique Landry, and Julie A. Bettinger. "Parents’ and Adolescents’ Willingness to be Vaccinated Against Serogroup B Meningococcal Disease during a Mass Vaccination in Saguenay–Lac-St-Jean (Quebec)." Canadian Journal of Infectious Diseases and Medical Microbiology 26, no. 3 (2015): 163–67. http://dx.doi.org/10.1155/2015/732464.

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A mass vaccination campaign with the 4CMenB vaccine (Bexsero®; Novartis Pharmaceutical Canada Inc) was launched in a serogroup B endemic area in Quebec. A telephone survey was conducted to assess parental and adolescent opinions about the acceptability of the vaccine. Intent to receive the vaccine or vaccine receipt was reported by the majority of parents (93%) and adolescents (75%). Meningitis was perceived as being a dangerous disease by the majority of parents and adolescents. The majority of respondents also considered the 4CMenB vaccine to be safe and effective. The main reason for positive vaccination intention or behaviour was self-protection, while a negative attitude toward vaccination in general was the main reason mentioned by parents who did not intend to have their child vaccinated. Adolescents mainly reported lack of interest, time or information, and low perceived susceptibility and disease severity as the main reasons for not intending to be vaccinated or not being vaccinated.
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Esposito, Susanna, Claudia Tagliabue, and Samantha Bosis. "Meningococcal B Vaccination (4CMenB) in Infants and Toddlers." Journal of Immunology Research 2015 (2015): 1–6. http://dx.doi.org/10.1155/2015/402381.

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Neisseria meningitidisis a Gram-negative pathogen that actively invades its human host and leads to the development of life-threatening pathologies. One of the leading causes of death in the world,N. meningitidiscan be responsible for nearly 1,000 new infections per 100,000 subjects during an epidemic period. The bacterial species are classified into 12 serogroups, five of which (A, B, C, W, and Y) cause the majority of meningitides. The three purified protein conjugate vaccines currently available target serogroups A, C, W, and Y. Serogroup B has long been a challenge but the discovery of the complete genome sequence of an MenB strain has allowed the development of a specific four-component vaccine (4CMenB). This review describes the pathogenetic role ofN. meningitidisand the recent literature concerning the new meningococcal vaccine.
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Donzelli, Alberto, and Piergiorgio Duca. "4CMenB safety and persistence of protection are unsatisfactory." Lancet Infectious Diseases 18, no. 6 (June 2018): 599–600. http://dx.doi.org/10.1016/s1473-3099(18)30271-8.

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Holmes, David. "UK poised to make decision on 4CMenB vaccine." Lancet Infectious Diseases 14, no. 3 (March 2014): 192–93. http://dx.doi.org/10.1016/s1473-3099(13)70345-1.

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Beck, Ekkehard, Johan Klint, Stephanie Garcia, Victoria Abbing, Veronique Abitbol, Orjan Akerborg, Lorenzo Argante, et al. "Modelling the impact of 4CMenB and MenACWY meningococcal combined vaccination strategies including potential 4CMenB cross-protection: An application to England." Vaccine 38, no. 47 (November 2020): 7558–68. http://dx.doi.org/10.1016/j.vaccine.2020.08.007.

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Garcia, Yara Ruiz, Woo-Yun Sohn, Mariagrazia Pizza, and Rafik Bekkat-Berkani. "02. Beyond B Antigen Coverage: The Potential of the 4CMenB Vaccine for Cross-protection Against Pathogenic Neisseria Infections." Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S125. http://dx.doi.org/10.1093/ofid/ofab466.205.

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Abstract Background Two human pathogenic Neisseria species exist: N. meningitidis (Nm) and N. gonorrhoeae (Ng). Although causing disparate clinical syndromes, invasive meningococcal disease (IMD) and gonorrhea, they are genetically similar and share key protein antigens. The 4CMenB vaccine, licensed against meningococcal B disease, comprises 4 antigenic components (factor H binding protein (fHbp), variant 1.1, subfamily B; Neisseria heparin binding antigen (NHBA) peptide 2; Neisserial adhesin A (NadA) variant 3; and Porin A (PorA) P1.4), and potentially protects against non-B invasive meningococcal and gonococcal strains. In this review, we summarize the similarities between these antigens and those in Nm serogroups A, C, W, X and Y and Ng. Methods Published data in humans were analyzed to conduct a narrative literature review of the potential extent of meningococcal vaccine-induced protection against non-B meningococcal strains and Ng. Techniques applied to indirectly measure this effect are based on genotype-phenotype modelling, strain coverage, bactericidal killing and direct impact on disease reduction. Results Data were identified from countries in America, Europe, Africa and Oceania. The genes encoding for fHbp and NHBA are also present in strains belonging to the five non-B serogroups, while NadA is present in several strains of serogroups C, W and Y, and PorA P1.4 mainly in serogroup W. At the genome level, Ng and Nm share up to 90% homology. Most of the outer membrane vesicle antigens, like PilQ, Omp85 (BamA), NspA, MtrE, MetQ, LbpA, PorB, FetA, OpcA and NHBA, are highly conserved in Ng. In addition, a synergistic effect might enhance immunogenicity against non-B serogroups as shown against serogroup B. Conclusion 4CMenB components are present and conserved in several Ng and Nm strains. Recent results demonstrate that 4CMenB reduces MenW disease incidence in infants and might generate cross-protection against other non-B serogroups. In addition, 4CMenB has been proven to be effective in reducing gonococcal infections in adolescents. Research on future genomic and proteomic characterizations of IMD and gonorrhea strains will provide information on the molecular basis of the underlying broad strain coverage, while informing decisions regarding prevention and immunization programmes. Disclosures Yara Ruiz Garcia, MSc, PhD, GSK group of companies (Employee) Woo-Yun Sohn, MD, GSK group of companies (Employee, Shareholder) Mariagrazia Pizza, Biological Sciences, PhD, GSK group of companies (Employee, Shareholder) Rafik Bekkat-Berkani, M.D, GSK group of companies (Employee, Shareholder)
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Carr, Jeremy, Emma Plested, Parvinder Aley, Susana Camara, Kimberly Davis, Jenny M. MacLennan, Steve Gray, et al. "‘Be on the TEAM’ Study (Teenagers Against Meningitis): protocol for a controlled clinical trial evaluating the impact of 4CMenB or MenB-fHbp vaccination on the pharyngeal carriage of meningococci in adolescents." BMJ Open 10, no. 10 (October 2020): e037358. http://dx.doi.org/10.1136/bmjopen-2020-037358.

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IntroductionCapsular group B Neisseria meningitidis (MenB) is the most common cause of invasive meningococcal disease (IMD) in many parts of the world. A MenB vaccine directed against the polysaccharide capsule remains elusive due to poor immunogenicity and safety concerns. The vaccines licensed for the prevention of MenB disease, 4CMenB (Bexsero) and MenB-fHbp (Trumenba), are serogroup B ‘substitute’ vaccines, comprised of subcapsular proteins and are designed to provide protection against most MenB disease-causing strains. In many high-income countries, such as the UK, adolescents are at increased risk of IMD and have the highest rates of meningococcal carriage. Beginning in the late 1990s, immunisation of this age group with the meningococcal group C conjugate vaccine reduced asymptomatic carriage and disrupted transmission of this organism, resulting in lower group C IMD incidence across all age groups. Whether vaccinating teenagers with the novel ‘MenB’ protein-based vaccines will prevent acquisition or reduce duration of carriage and generate herd protection was unknown at the time of vaccine introduction and could not be inferred from the effects of the conjugate vaccines. 4CMenB and MenB-fHbp may also impact on non-MenB disease-causing capsular groups as well as commensal Neisseria spp. This study will evaluate the impact of vaccination with 4CMenB or MenB-fHbp on oropharyngeal carriage of pathogenic meningococci in teenagers, and consequently the potential for these vaccines to provide broad community protection against MenB disease.Methods and analysisThe ‘Be on the TEAM’ (Teenagers Against Meningitis) Study is a pragmatic, partially randomised controlled trial of 24 000 students aged 16–19 years in their penultimate year of secondary school across the UK with regional allocation to a 0+6 month schedule of 4CMenB or MenB-fHbp or to a control group. Culture-confirmed oropharyngeal carriage will be assessed at baseline and at 12 months, following which the control group will be eligible for 4CMenB vaccination. The primary outcome is the carriage prevalence of potentially pathogenic meningococci (defined as those with genogroups B, C, W, Y or X), in each vaccine group compared separately to the control group at 12 months post-enrolment, that is, 12 months after the first vaccine dose and 6 months after the second vaccine dose. Secondary outcomes include impact on carriage of: genogroup B meningococci; hyperinvasive meningococci; all meningococci; those meningococci expressing vaccine antigens and; other Neisseria spp. A sample size of 8000 in each arm will provide 80% power to detect a 30% reduction in meningococcal carriage, assuming genogroup B, C, W, Y or X meningococci carriage of 3.43%, a design effect of 1.5, a retention rate of 80% and a significance level of 0.05. Study results will be available in 2021 and will inform the UK and international immunisation policy and future vaccine development.Ethics and disseminationThis study is approved by the National Health Service South Central Research Ethics Committee (18/SC/0055); the UK Health Research Authority (IRAS ID 239091) and the UK Medicines and Healthcare products Regulatory Agency. Publications arising from this study will be submitted to peer-reviewed journals. Study results will be disseminated in public forums, online, presented at local and international conferences and made available to the participating schools.Trial registration numbersISRCTN75858406; Pre-results, EudraCT 2017-004609-42.
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Channon-Wells, Samuel William, Emily Tough, Neda So, Daniel O'Connor, and Matthew D. Snape. "Differentiating vaccine reactions from invasive bacterial infections in young infants presenting to the emergency department in the 4CMenB era: a retrospective observational comparison." BMJ Paediatrics Open 6, no. 1 (October 2022): e001559. http://dx.doi.org/10.1136/bmjpo-2022-001559.

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BackgroundDifferentiating infants with adverse events following immunisation (AEFIs) or invasive bacterial infection (IBI) is a significant clinical challenge. Young infants post vaccination are therefore often admitted to the hospital for parenteral antibiotics to avoid missing rare cases of IBI.MethodsDuring a service evaluation project, we conducted a single-centre retrospective observational study of infants with IBI, urinary tract infection (UTI) or AEFI from two previously published cohorts. All patients presented to hospital in Oxfordshire, UK, between 2011 and 2018, spanning the introduction of the capsular group-B meningococcal vaccine (4CMenB) into routine immunisation schedules. Data collection from paper and electronic notes were unblinded. Clinical features, including National Institute for Health and Care Excellence (NICE) ‘traffic light’ risk of severe illness and laboratory tests performed on presentation, were described, and comparisons made using regression models, adjusting for age and sex. We also compared biochemical results on presentation to those of well infants post vaccination, with and without 4CMenB regimens.ResultsThe study included 232 infants: 40 with IBI, 97 with probable AEFI, 24 with possible AEFI, 27 with UTI and 44 post vaccination ‘well’ infants. C-reactive protein (CRP) was the only discriminatory blood marker, with CRP values above 83 mg/L only observed in infants with IBI or UTI. NICE risk stratification was significantly different between groups but still missed cases of IBI, and classification as intermediate risk was non-differential. Fever was more common in probable AEFI cases, while seizures and rashes were equally frequent. Diarrhoea and clinician-reported irritability or rigours were all more common in IBI.ConclusionsClinical features on presentation may aid risk stratification but cannot reliably differentiate IBI from AEFI in infants presenting to the emergency department. Blood results are generally unhelpful due to post vaccination inflammatory responses, particularly in children receiving 4CMenB vaccination. Improved biomarkers and clinical prediction tools are required to aid management in febrile infants post vaccination.
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Lamoudi, Maya, Faye Baxter, Amarpal Bilkhu, and Claire Hathorn. "4CMenB and post-immunisation fever: an emerging hot topic." Archives of Disease in Childhood 103, no. 10 (January 27, 2018): 1002–3. http://dx.doi.org/10.1136/archdischild-2017-314645.

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Abad, Raquel, and Julio Vazquez. "Should we continue to monitor 4CMenB coverage with MATS?" Lancet Infectious Diseases 17, no. 7 (July 2017): 681–83. http://dx.doi.org/10.1016/s1473-3099(17)30174-3.

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Rose, Warren E. "Meningococcal serogroup B outbreaks and use of 4CMenB vaccine." Journal of the American Pharmacists Association 54, no. 2 (March 2014): 198–201. http://dx.doi.org/10.1331/japha.2014.14512.

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Law, Dennis K. S., Jianwei Zhou, Saul Deng, Linda Hoang, Gregory Tyrrell, Greg Horsman, John Wylie, and Raymond S. W. Tsang. "Determination of serotyping antigens, clonal analysis and genetic characterization of the 4CMenB vaccine antigen genes in invasive Neisseria meningitidis from Western Canada, 2009 to 2013." Journal of Medical Microbiology 63, no. 11 (November 1, 2014): 1490–99. http://dx.doi.org/10.1099/jmm.0.079921-0.

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This study examined invasive Neisseria meningitidis recovered from invasive meningococcal disease (IMD) cases in Western Canada between 2009 and 2013. A total of 161 isolates from individual IMD cases were analysed for serogroup, serotype, serosubtype, PorA genotype, multi-locus sequence type and nucleotide sequence of their 4CMenB vaccine antigen genes. Sixty-nine isolates were serogroup B (MenB), 47 were serogroup Y (MenY), 22 were serogroup C (MenC), 19 were serogroup W (MenW), three were serogroup E and one was non-encapsulated. MenC, MenY and MenW were mainly clonal, represented primarily by clonal complex (cc) 11, cc23 or cc167, and cc22, respectively. In contrast, MenB were composed of eight different ccs together with 11 isolates not assigned to any known cc. Antigenic analysis and PorA genotyping confirmed the heterogeneity of MenB isolates, while such results supported the clonal nature of most MenC, MenY and MenW isolates. Thirty-four (21.1 %) isolates had at least one gene that encoded one matching vaccine protein component of the 4CMenB vaccine (i.e. PorA P1.4; fHbp variant 1.1; NHBA peptide 2; and NadA-1, -2, or -3). An additional 18 isolates had genes that encoded variant 1 or subfamily B factor H binding proteins of this same vaccine.
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Esposito, Susanna, and Nicola Principi. "Vaccine profile of 4CMenB: a four-componentNeisseria meningitidisserogroup B vaccine." Expert Review of Vaccines 13, no. 2 (January 6, 2014): 193–202. http://dx.doi.org/10.1586/14760584.2014.874949.

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Hernández-García, Ignacio, Silvio Ragozzino, and Teresa Giménez-Júlvez. "Characteristics of YouTube videos about the meningococcal B vaccine (4CMenB)." Human Vaccines & Immunotherapeutics 16, no. 10 (March 2, 2020): 2513–17. http://dx.doi.org/10.1080/21645515.2020.1726683.

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Manzoli, Lamberto, and Maria Elena Flacco. "4CMenB safety and persistence of protection are unsatisfactory – Authors' reply." Lancet Infectious Diseases 18, no. 6 (June 2018): 600–601. http://dx.doi.org/10.1016/s1473-3099(18)30282-2.

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40

Marshall, H. S., A. P. Koehler, B. Wang, M. A'Houre, M. Gold, H. Quinn, N. Crawford, N. Pratt, T. R. Sullivan, and K. Macartney. "Safety of meningococcal B vaccine (4CMenB) in adolescents in Australia." Vaccine 38, no. 37 (August 2020): 5914–22. http://dx.doi.org/10.1016/j.vaccine.2020.07.009.

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41

Castilla, Jesús, Manuel García Cenoz, Raquel Abad, Laura Sánchez-Cambronero, Nicola Lorusso, Conchita Izquierdo, Soledad Cañellas Llabrés, et al. "Effectiveness of a Meningococcal Group B Vaccine (4CMenB) in Children." New England Journal of Medicine 388, no. 5 (February 2, 2023): 427–38. http://dx.doi.org/10.1056/nejmoa2206433.

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Simões, Maria João, Célia Bettencourt, Rosita De Paola, Maria Giuliani, Mariagrazia Pizza, Monica Moschioni, and Jorge Machado. "Predicted strain coverage of a meningococcal multicomponent vaccine (4CMenB) in Portugal." PLOS ONE 12, no. 5 (May 1, 2017): e0176177. http://dx.doi.org/10.1371/journal.pone.0176177.

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43

Ladhani, Shamez N., Nick Andrews, Sydel R. Parikh, Helen Campbell, Joanne White, Michael Edelstein, Xilian Bai, Jay Lucidarme, Ray Borrow, and Mary E. Ramsay. "Vaccination of Infants with Meningococcal Group B Vaccine (4CMenB) in England." New England Journal of Medicine 382, no. 4 (January 23, 2020): 309–17. http://dx.doi.org/10.1056/nejmoa1901229.

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44

Tenenbaum, T. "Meningokokken-Impfung." Kinder- und Jugendmedizin 14, no. 01 (2014): 22–25. http://dx.doi.org/10.1055/s-0038-1629369.

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ZusammenfassungIn Deutschland werden bereits Polysaccharid- und Konjugatimpfstoffe gegen Meningokokken der Serogruppe A, C, W135 und Y nach STIKO-Empfehlung eingesetzt. Seit An-fang 2013 ist nun auch ein neuer rekombinanter 4-Komponenten-MeningokokkenB-Impfstoff (4CMenB) zugelassen. Die Abdeckung der in Deutschland zirkulierenden Stämme durch den Impfstoff beträgt ungefähr 80 %. Immunogenität und Sicherheit sind für unterschiedlichste Impfschemata im Säuglingsalter und darüber hinaus untersucht, ebenso die Koadministrationen mit Standardimpfstoffen. Die STIKO hat im Dezember 2013 eine Stellungnahme zum Stand der Bewertung des neuen MeningokokkenB-Impfstoffes Bexsero herausgegeben.
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Abad, R., A. Biolchi, M. Moschioni, M. M. Giuliani, M. Pizza, and J. A. Vázquez. "A Large Portion of Meningococcal Antigen Typing System-Negative Meningococcal Strains from Spain Is Killed by Sera from Adolescents and Infants Immunized with 4CMenB." Clinical and Vaccine Immunology 22, no. 4 (January 28, 2015): 357–60. http://dx.doi.org/10.1128/cvi.00669-14.

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ABSTRACTA new vaccine (the 4CMenB 4-component protein vaccine [Bexsero], which includes PorA, factor H-binding protein [fHbp], neisserial heparin-binding antigen [NHBA], andNeisseriaadhesin A [NadA]) against serogroup B meningococci has recently been approved for use in people older than age 2 months in Europe, Australia, and Canada. Preapproval clinical efficacy studies are not feasible for invasive meningococcal disease because its incidence is low/very low, and the serum bactericidal antibody (SBA) titer (or the human SBA [hSBA] titer when human complement is used in the assay) has been used as a surrogate marker of protection. However, the hSBA assay cannot be used on a large scale, and therefore, a meningococcal antigen typing system (MATS) was developed. MATS combines conventional PorA genotyping with an enzyme-linked immunosorbent assay (ELISA) that quantifies both the expression and the cross-reactivity of antigenic variants. The assay has been used to evaluate the potential of the 4CMenB meningococcal group B vaccine to cover group B strains in several countries. Some recent data suggest that MATS is a conservative predictor of strain coverage. We used pooled sera from adolescents and infants to test by the hSBA assay 10 meningococcal group B strains isolated in Spain that were negative for the 3 antigens (n= 9) or that had very low levels of the 3 antigens (n= 1) by MATS. We found that all strains were killed by sera from adolescents and that 5 of the 10 strains were also killed, although at a low titer, by sera from infants. Our data confirm that MATS underestimates vaccine coverage.
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46

Longtin, Jean, Rejean Dion, Marc Simard, Jean-Francois Betala Belinga, Yves Longtin, Brigitte Lefebvre, Annie-Claude Labbé, Genevieve Deceuninck, and Philippe De Wals. "Possible Impact of Wide-scale Vaccination Against Serogroup B Neisseria Meningitidis on Gonorrhea Incidence Rates in One Region of Quebec, Canada." Open Forum Infectious Diseases 4, suppl_1 (2017): S734—S735. http://dx.doi.org/10.1093/ofid/ofx180.002.

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Abstract Background Owing to a persistent increase of serogroup B Neisseria meningitidis (Nm) invasive infections in the Saguenay-Lac-Saint-Jean (SLSJ) region of the province of Quebec (Canada) since 2006, a wide-scale vaccination campaign of individuals aged 6 months to 20 years was conducted between May and December 2014 using the 4-component protein-based meningococcus serogroup B vaccine (4CMenB). Components of this vaccine have shown to potentially cross-react with Neisseria gonorrhoeae (Ng). The study objective was to assess the impact of the vaccination campaign on Ng incidence rate (IR). Methods Ng cases notified to public health authorities during prevaccination period (January 2006 to June 2014) and postvaccination period (July 2014 to June 2017) were analyzed. The impact of this mass campaign was estimated by a Poisson regression model, including the year (11 July–June categories), age (14–20 vs. 21 years and older), and the intervention (0 by default and 1 in those 14–20 years in the period of July 2014 to June 2017). Results Overall vaccine coverage was 82% in the target group. A total of 231 Ng cases were reported among persons 14 years and older (IR: 8.4/100,000 person-years) of the SLSJ region from January 2006 to June 2017. A decrease in the Ng number of cases and IR among individuals 14–20 years was observed during the post-vaccination period whereas it increased in those 21 years and older (figure). Estimate of vaccination impact was an Ng risk reduction of 59% (95% CI: −22% to 84%; P = 0.1). During the same period, Chlamydia trachomatis (Ct) infections increased among persons of both age groups in the SLSJ region. Conclusion Although the estimate of the impact of the campaign was not statistically significant, possibly due to limited size of the study population and the low incidence of the disease, it is congruent with results of a case–control study in New Zealand showing an OMV-MeNZB vaccine effectiveness of 31%. A higher effectiveness of 4CMenB is a plausible hypothesis as three additional proteins also found in Ng are included in the vaccine used in the SLSJ region. The results of this ecologic study suggest cross-protection of 4CMenB vaccine against Ng infections. Further studies on this topic are warranted. Disclosures P. De Wals, GlaxoSmithKline: Grant Investigator and Scientific Advisor, Grant recipient and travel expenses. Pfizer: Grant Investigator and Scientific Advisor, Grant recipient and travel expenses. Sanofi-Pasteur: Grant Investigator and Scientific Advisor, Grant recipient and travel expenses. Novartis: Grant Investigator and Scientific Advisor, Grant recipient and travel expenses.
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McMillan, Mark, Helen S. Marshall, and Peter Richmond. "4CMenB vaccine and its role in preventing transmission and inducing herd immunity." Expert Review of Vaccines 21, no. 1 (November 29, 2021): 103–14. http://dx.doi.org/10.1080/14760584.2022.2003708.

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48

Harrison, Lee H., and David S. Stephens. "Good News and Bad News — 4CMenB Vaccine for Group B Neisseria meningitidis." New England Journal of Medicine 382, no. 4 (January 23, 2020): 376–78. http://dx.doi.org/10.1056/nejme1916440.

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Rappuoli, Rino, Mariagrazia Pizza, Vega Masignani, and Kumaran Vadivelu. "Meningococcal B vaccine (4CMenB): the journey from research to real world experience." Expert Review of Vaccines 17, no. 12 (December 2, 2018): 1111–21. http://dx.doi.org/10.1080/14760584.2018.1547637.

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50

Medini, Duccio, Maria Stella, and James Wassil. "MATS: Global coverage estimates for 4CMenB, a novel multicomponent meningococcal B vaccine." Vaccine 33, no. 23 (May 2015): 2629–36. http://dx.doi.org/10.1016/j.vaccine.2015.04.015.

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