A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program.

Abstract

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.

• Authors: Miguel O'Ryan, Jeffrey Stoddard, Daniela Toneatto, James Wassil, Peter M Dull
• Journal: Drugs (Drugs) Vol. 74 Issue 1 Pg. 15-30 (Jan 2014) ISSN: 1179-1950 [Electronic] New Zealand
• PMID: 24338083 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review)

Chemical References

• 4CMenB vaccine
• Meningococcal Vaccines

Topics

• Clinical Trials as Topic
• Drug Administration Schedule
• Humans
• Meningococcal Infections (immunology, prevention & control)
• Meningococcal Vaccines (administration & dosage, adverse effects, immunology, therapeutic use)