Understanding immunogenicity assessments for meningococcal serogroup B vaccines

References

• Read RC. Neisseria meningitidis; clones, carriage, and disease. Clin Microbiol Infect. 2014;20(5):391–395.
   PubMed Web of Science ®Google Scholar
• Dwilow R, Fanella S. Invasive meningococcal disease in the 21st century-an update for the clinician. Curr Neurol Neurosci Rep. 2015;15(3):2.
   PubMed Web of Science ®Google Scholar
• Kaplan SL, Schutze GE, Leake JA, et al. Multicenter surveillance of invasive meningococcal infections in children. Pediatrics. 2006;118(4):e979–84.
   PubMed Web of Science ®Google Scholar
• Vyse A, Anonychuk A, Jakel A, et al. The burden and impact of severe and long-term sequelae of meningococcal disease. Expert Rev Anti Infect Ther. 2013;11(6):597–604.
   PubMed Web of Science ®Google Scholar
• Pelton SI. The global evolution of meningococcal epidemiology following the introduction of meningococcal vaccines. J Adolesc Health. 2016;59(suppl 2):S3–S11.
   PubMed Web of Science ®Google Scholar
• Chang Q, Tzeng YL, Stephens DS. Meningococcal disease: changes in epidemiology and prevention. Clin Epidemiol. 2012;4:237–245.
   PubMedGoogle Scholar
• Nadel S, Ninis N. Invasive meningococcal disease in the vaccine era. Front Pediatr. 2018;6:321.
   PubMed Web of Science ®Google Scholar
• CDC. Enhanced meningococcal disease surveillance report, 2015 [Internet]. 2015 [cited 2020 January 7]. Available from: https://www.cdc.gov/meningococcal/downloads/NCIRD-EMS-Report-2015.pdf
   Google Scholar
• European Centre for Disease Prevention and Control. Annual epidemiological report for 2017 invasive meningococcal disease [Internet]. 2017 [cited 2019 Apr 24]. Available from: https://ecdc.europa.eu/sites/portal/files/documents/AER_for_2017-invasive-meningococcal-disease.pdf
   Google Scholar
• Borrow R, Miller E. Surrogates of protection. In: Matthias Frosch and Martin C. J, editors. Handbook of Meningococcal Disease: Infection Biology, Vaccination, Clinical Management. Weinheim: Wiley-VCH; 2006. p. 323–351.
   Google Scholar
• World Health Organization. WHO expert committee on biological standardization: twenty-seventh report [Internet]. 1976 [cited2020 January 7]. Available from: http://apps.who.int/iris/bitstream/handle/10665/37954/WHO_TRS_594.pdf?sequence=1&isAllowed=y
   Google Scholar
• Zlotnick GW, Jones TR, Liberator P, et al. The discovery and development of a novel vaccine to protect against Neisseria meningitidis serogroup B disease. Hum Vaccin Immunother. 2015;11(1):5–13.
   PubMed Web of Science ®Google Scholar
• Borrow R, Balmer P, Miller E. Meningococcal surrogates of protection—serum bactericidal antibody activity. Vaccine. 2005;23(17–18):2222–2227.
   PubMed Web of Science ®Google Scholar
• Gandhi A, Balmer P, York LJ. Characteristics of a new meningococcal serogroup B vaccine, bivalent rLP2086 (MenB-FHbp; Trumenba®). Postgrad Med. 2016;128(6):548–556.
   PubMed Web of Science ®Google Scholar
• Vermont C. van den Dobbelsteen G. Neisseria meningitidis serogroup B: laboratory correlates of protection. FEMS Immunol Med Microbiol. 2002;34(2):89–96.
   PubMedGoogle Scholar
• Donald RG, Hawkins JC, Hao L, et al. Meningococcal serogroup B vaccines: estimating breadth of coverage. Hum Vaccin Immunother. 2017;13(2):255–265.
   PubMed Web of Science ®Google Scholar
• Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129(6):1307–1326.
   PubMed Web of Science ®Google Scholar
• Gill CJ, Ram S, Welsch JA, et al. Correlation between serum bactericidal activity against Neisseria meningitidis serogroups A, C, W-135 and Y measured using human versus rabbit serum as the complement source. Vaccine. 2011;30(1):29–34.
   PubMed Web of Science ®Google Scholar
• Santos GF, Deck RR, Donnelly J, et al. Importance of complement source in measuring meningococcal bactericidal titers. Clin Diagn Lab Immunol. 2001;8(3):616–623.
   PubMedGoogle Scholar
• Andrews N, Borrow R, Miller E. Validation of serological correlate of protection for meningococcal C conjugate vaccine by using efficacy estimates from postlicensure surveillance in England. Clin Diagn Lab Immunol. 2003;10(5):780–786.
   PubMedGoogle Scholar
• Borrow R, Andrews N, Goldblatt D, et al. Serological basis for use of meningococcal serogroup C conjugate vaccines in the United Kingdom: reevaluation of correlates of protection. Infect Immun. 2001;69(3):1568–1573.
   PubMed Web of Science ®Google Scholar
• Frasch CE, Preziosi MP, LaForce FM. Development of a group A meningococcal conjugate vaccine, MenAfriVac(TM). Hum Vaccin Immunother. 2012;8(6):715–724.
   PubMed Web of Science ®Google Scholar
• Menactra® (MCV4). Full prescribing information [package insert]. Swiftwater, PA: Sanofi Pasteur Inc.; 2016.
   Google Scholar
• European Medicines Agency. Summary of opinion (Nimenrix®) [Internet]. 2012 [cited2020 January 7]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002226/WC500122859.pdf
   Google Scholar
• European Medicines Agency. Assessment report for Menveo [Internet]. 2009 [cited2020 January 7]. Available from: https://www.ema.europa.eu/documents/assessment-report/menveo-epar-public-assessment-report_en.pdf
   Google Scholar
• Centers for Disease Control and Prevention. Licensure of a meningococcal conjugate vaccine (Menveo) and guidance for use - advisory committee on immunization practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep. 2010;59(9):273.
   PubMedGoogle Scholar
• Zollinger WD, Mandrell RE. Importance of complement source in bactericidal activity of human antibody and murine monoclonal antibody to meningococcal group B polysaccharide. Infect Immun. 1983;40(1):257–264.
   PubMed Web of Science ®Google Scholar
• Schneider MC, Exley RM, Chan H, et al. Functional significance of factor H binding to Neisseria meningitidis. J Immunol. 2006;176(12):7566–7575.
   PubMed Web of Science ®Google Scholar
• Granoff DM, Welsch JA, Ram S. Binding of complement factor H (fH) to Neisseria meningitidis is specific for human fH and inhibits complement activation by rat and rabbit sera. Infect Immun. 2009;77(2):764–769.
   PubMed Web of Science ®Google Scholar
• Borrow R, Carlone GM, Rosenstein N, et al. Neisseria meningitidis group B correlates of protection and assay standardization–international meeting report emory university, Atlanta, Georgia, United States, 16–17 March 2005. Vaccine. 2006;24(24):5093–5107.
   PubMed Web of Science ®Google Scholar
• McIntosh ED, Broker M, Wassil J, et al. Serum bactericidal antibody assays - the role of complement in infection and immunity. Vaccine. 2015;33(36):4414–4421.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Bexsero EPAR summary for the public [Internet]. 2012 [cited2020 January 7]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002333/WC500137857.pdf
   Google Scholar
• Folaranmi T, Rubin L, Martin SW, et al. Use of serogroup B meningococcal vaccines in persons aged ≥10 years at increased risk for serogroup B meningococcal disease: recommendations of the advisory committee on immunization practices, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(22):608–612.
   PubMed Web of Science ®Google Scholar
• Trumenba® (meningococcal group B vaccine) Summary of Product Characteristics. Full prescribing information [package insert]. Sandwich, UK: Pfizer Ltd; 2017.
   Google Scholar
• Bexsero (MenB-4C). Full prescribing information [package insert]. Abbotsford, Victoria, Australia: GlaxoSmithKline Australia Pty Ltd; 2017.
   Google Scholar
• Granoff DM, Pollard AJ, Harrison LH. Meningococcal capsular group B vaccines. In: Stanley Plotkin, Paul Offit, Walter Orenstein, and Kathryn Edwards, editors. Plotkin’s vaccines. Elsevier; 2018. p. 644–62.e46.
   Google Scholar
• Trumenba (MenB-FHbp [bivalent rLP2086]). Full prescribing information [package insert]. West Ryde, NSW, Australia: Pfizer Australia Pty Ltd; 2017.
   Google Scholar
• Vesikari T, Esposito S, Prymula R, et al. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013;381(9869):825–835.
   PubMed Web of Science ®Google Scholar
• MacNeil JR, Rubin L, Folaranmi T, et al. Use of serogroup B meningococcal vaccines in adolescents and young adults: recommendations of the advisory committee on immunization practices, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(41):1171–1176.
   PubMed Web of Science ®Google Scholar
• Trumenba® (meningococcal group B vaccine). Full Prescribing Information [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc (a subsidiary of Pfizer Inc); 2018.
   Google Scholar
• Bexsero® (Meningococcal Group B Vaccine). Full Prescribing Information [package insert]. Siena, Italy: GSK Vaccines, Srl; 2018.
   Google Scholar
• Neisseria PorA typing. [Internet]. 2019 [cited 2019 May 24]. Available from: https://pubmlst.org/neisseria/PorA/
   Google Scholar
• NadA sequence typing. [Internet]. 2019 [cited 2019 May 24]. Available from: https://pubmlst.org/neisseria/NadA/
   Google Scholar
• Neisserial heparin binding antigen (NHBA) protein sequence typing. [Internet]. 2019 [cited 2019 May 24]. Available from: https://pubmlst.org/neisseria/NHBA/
   Google Scholar
• Neisseria Factor H binding protein sequence typing. [Internet]. 2019 [cited 2019 May 24]. Available from: https://pubmlst.org/neisseria/fHbp/
   Google Scholar
• Jiang HQ, Hoiseth SK, Harris SL, et al. Broad vaccine coverage predicted for a bivalent recombinant factor H binding protein based vaccine to prevent serogroup B meningococcal disease. Vaccine. 2010;28(37):6086–6093.
   PubMed Web of Science ®Google Scholar
• McNeil LK, Donald RGK, Gribenko A, et al. Predicting the susceptibility of meningococcal serogroup B isolates to bactericidal antibodies elicited by bivalent rLP2086, a novel prophylactic vaccine. MBio. 2018;9(2):e00036–18.
   PubMed Web of Science ®Google Scholar
• Walsh CT, Garneau-Tsodikova S, Gatto GJ Jr. Protein posttranslational modifications: the chemistry of proteome diversifications. Angew Chem Int Ed Engl. 2005;44(45):7342–7372.
   PubMed Web of Science ®Google Scholar
• Fletcher LD, Bernfield L, Barniak V, et al. Vaccine potential of the Neisseria meningitidis 2086 lipoprotein. Infect Immun. 2004;72(4):2088–2100.
   PubMed Web of Science ®Google Scholar
• Giuliani MM, Adu-Bobie J, Comanducci M, et al. A universal vaccine for serogroup B meningococcus. Proc Natl Acad Sci U S A. 2006;103(29):10834–10839.
   PubMed Web of Science ®Google Scholar
• Masignani V, Comanducci M, Giuliani MM, et al. Vaccination against Neisseria meningitidis using three variants of the lipoprotein GNA1870. J Exp Med. 2003;197(6):789–799.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. EPAR summary for the public: bexsero [Internet]. 2015 [cited2020 January 7]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002333/WC500137857.pdf
   Google Scholar
• Martinon-Torres F, Carmona Martinez A, Simko R, et al. Antibody persistence and booster responses 24–36 months after different 4CMenB vaccination schedules in infants and children: a randomised trial. J Infect. 2018;76(3):258–269.
   PubMed Web of Science ®Google Scholar
• O’Ryan M, Stoddard J, Toneatto D, et al. A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program. Drugs. 2014;74(1):15–30.
   PubMed Web of Science ®Google Scholar
• Snape MD, Saroey P, John TM, et al. Persistence of bactericidal antibodies following early infant vaccination with a serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose. CMAJ. 2013;185(15):E715–24.
   PubMed Web of Science ®Google Scholar
• Findlow J, Borrow R, Snape MD, et al. Multicenter, open-label, randomized phase II controlled trial of an investigational recombinant meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy. Clin Infect Dis. 2010;51(10):1127–1137.
   PubMed Web of Science ®Google Scholar
• Soeters HM, Dinitz-Sklar J, Kulkarni PA, et al. Serogroup B meningococcal disease vaccine recommendations at a university, New Jersey, USA, 2016. Emerg Infect Dis. 2017;23(5):867–869.
   PubMed Web of Science ®Google Scholar
• Medini D, Stella M, Wassil J. MATS: global coverage estimates for 4CMenB, a novel multicomponent meningococcal B vaccine. Vaccine. 2015;33(23):2629–2636.
   PubMed Web of Science ®Google Scholar
• Donnelly J, Medini D, Boccadifuoco G, et al. Qualitative and quantitative assessment of meningococcal antigens to evaluate the potential strain coverage of protein-based vaccines. Proc Natl Acad Sci U S A. 2010;107(45):19490–19495.
   PubMed Web of Science ®Google Scholar
• Rajam G, Stella M, Kim E, et al. Meningococcal antigen typing system (MATS)-based neisseria meningitidis serogroup B coverage prediction for the MenB-4C vaccine in the United States. mSphere. 2017;2(6):e00261–17.
   PubMed Web of Science ®Google Scholar
• Bexsero (Meningococcal group B vaccine). Summary of product characteristics. GSK Vaccines Srl. 2017. Siena, Italy.
   Google Scholar
• Joint Committee on Vaccination and Immunisation. Minute of the meeting on 03 October 2018 [Internet]. 2018 [cited 2019 Oct 24].
   Google Scholar
• Biolchi A, Tomei S, Santini L, et al. Evaluation of strain coverage of the multicomponent meningococcal serogroup B vaccine (4CMenB) administered in infants according to different immunisation schedules. Hum Vaccin Immunother. 2019;15(3):725–731.
   PubMed Web of Science ®Google Scholar
• Basta NE, Mahmoud AAF, Wolfson J, et al. Meningococcal B vaccine (4CMenB) immunogenicity pre- and post-vaccination among university students in the US. Paper presented at: European Society for Paediatric Infectious Diseases Congress 36th Annual Meeting; 2018 May 28-June 2; Malmo, Sweden.
   Google Scholar
• McNamara LA, Shumate AM, Johnsen P, et al. First use of a serogroup B meningococcal vaccine in the US in response to a university outbreak. Pediatrics. 2015;135(5):798–804.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Assessment Report: Trumenba [Internet]. 2017 [cited 2019 Oct 17]. Available from: https://www.ema.europa.eu/documents/assessment-report/trumenba-epar-public-assessment-report_en.pdf
   Google Scholar
• Muse D, Christensen S, Bhuyan P, et al. A phase 2, randomized, active-controlled, observer-blinded study to assess the immunogenicity, tolerability and safety of bivalent rLP2086, a meningococcal serogroup B vaccine, coadministered with tetanus, diphtheria and acellular pertussis vaccine and serogroup A, C, Y and W-135 meningococcal conjugate vaccine in healthy US adolescents. Pediatr Infect Dis J. 2016;35(6):673–682.
   PubMed Web of Science ®Google Scholar
• Senders S, Bhuyan P, Jiang Q, et al. Immunogenicity, tolerability, and safety in adolescents of bivalent rLP2086, a meningococcal serogroup B vaccine, coadministered with quadrivalent human papilloma virus vaccine. Pediatr Infect Dis J. 2016;35(5):548–554.
   PubMed Web of Science ®Google Scholar
• Vesikari T, Ostergaard L, Diez-Domingo J, et al. Meningococcal serogroup B bivalent rLP2086 vaccine elicits broad and robust serum bactericidal responses in healthy adolescents. J Pediatric Infect Dis Soc. 2016;5(2):152–160.
   PubMed Web of Science ®Google Scholar
• Vesikari T, Wysocki J, Beeslaar J, et al. Immunogenicity, safety, and tolerability of bivalent rLP2086 meningococcal group B vaccine administered concomitantly with diphtheria, tetanus, and acellular pertussis and inactivated poliomyelitis vaccines to healthy adolescents. J Pediatric Infect Dis Soc. 2016;5(2):180–187.
   PubMed Web of Science ®Google Scholar
• Ostergaard L, Vesikari T, Absalon J, et al. A bivalent meningococcal B vaccine in adolescents and young adults. N Engl J Med. 2017;377(24):2349–2362.
   PubMed Web of Science ®Google Scholar
• Harris SL, Donald RG, Hawkins JC, et al. Neisseria meningitidis serogroup B vaccine, bivalent rLP2086, induces broad serum bactericidal activity against diverse invasive disease strains including outbreak strains. Pediatr Infect Dis J. 2017;36(2):216–223.
   PubMed Web of Science ®Google Scholar
• Taha MK, Hawkins JC, Liberator P, et al. Bactericidal activity of sera from adolescents vaccinated with bivalent rLP2086 against meningococcal serogroup B outbreak strains from France. Vaccine. 2017;35(11):1530–1537.
   PubMed Web of Science ®Google Scholar