A Multi-Component Meningococcal Serogroup B Vaccine (4CMenB): The Clinical Development Program

被引：0
作者：
Miguel O’Ryan
Jeffrey Stoddard
Daniela Toneatto
James Wassil
Peter M. Dull
机构：
[1] Universidad de Chile,Programa de Microbiología y Micología, Instituto de Ciencias Biomédicas, Facultad de Medicina
[2] Novartis Vaccines and Diagnostics,undefined
来源：
Drugs | 2014年 / 74卷
关键词：
Kawasaki Disease; Vaccine Antigen; Invasive Meningococcal Disease; Clinical Development Program; Bactericidal Antibody;
D O I：
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中图分类号：
学科分类号：
摘要：
Recently approved in Europe and Australia, the multi-component meningococcal B vaccine, 4CMenB (Bexsero®, Novartis Vaccines and Diagnostics), contains three surface-exposed recombinant proteins (fHbp, NadA, and NHBA) and New Zealand strain outer membrane vesicles (NZ OMV) with PorA 1.4 antigenicity. This comprehensive review of the 4CMenB clinical development program covers pivotal phase I/IIb/III studies in over 7,000 adults, adolescents, and infants. The immunological correlate for clinical protection used was human complement-mediated serum bactericidal activity titers ≥4 or 5 against indicator strains for individual antigens. Based on achievement of protective titers, a four-dose schedule (three primary doses and one booster dose) for infants and a two-dose schedule for adolescents provided the best results. Observed increases in injection site pain/tenderness and fever in infants, and injection site pain, malaise, and headache in adolescents compared with routine vaccines, were mostly mild to moderate; frequencies of rare events (Kawasaki disease, juvenile arthritis) were not significantly different from non-vaccinated individuals. 4CMenB is conservatively estimated to provide 66–91 % coverage against meningococcal serogroup B strains worldwide.
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页码：15 / 30
页数：15
相关论文
共 113 条
[1]  
Racloz VN(2010)The elusive meningococcal meningitis serogroup: a systematic review of serogroup B epidemiology BMC Infect Dis 10 175-183
[2]  
Luiz SJ(2013)Controlling serogroup B invasive meningococcal disease: the Canadian perspective Exp Rev Vacc 12 505-517
[3]  
Bettinger JA(2012)The changing and dynamic epidemiology of meningococcal disease Vaccine 30 B26-B36
[4]  
Deeks SL(2013)The current situation of meningococcal disease in Latin America and recommendations for a new case definition from the Global Meningococcal Initiative Exp Rev Vaccines 12 903-915
[5]  
Halperin SA(2011)Meningococcal serogroup B vaccines: will they live up to expectations? Expert Rev Vaccines 10 559-561
[6]  
Tsang R(2007)Molecular typing of meningococci: recommendations for target choice and nomenclature FEMS Microbiol Rev 31 89-96
[7]  
Scheifele DW(1991)Effect of outer membrane vesicle vaccine against group B meningococcal disease in Norway Lancet 338 1093-1096
[8]  
Halperin SA(2009)Properties and clinical performance of vaccines containing outer membrane vesicles from Vaccine 27 B3-B12
[9]  
Bettinger JA(2009)Delivering a safe and effective strain-specific vaccine to control an epidemic of group B meningococcal disease N Z Med J 122 48-59
[10]  
Greenwood B(2011)Extensive genomic variation within clonal complexes of Genome Biol Evol 3 1406-1418
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