Immunogenicity and safety of the multicomponent meningococcal B vaccine (4CMenB): a meta-analysis

Background The evidence on multicomponent Meningococcal B vaccine (4CMenB) is highly fragmented and heterogeneous, and uncertainties remain on the lowest number of doses inducing a satisfactory immune response. We systematically appraised the evidence on the immunogenicity and safety of the multicomponent Meningococcal B (4CMenB) vaccine and performed proportion, head-to-head-comparison and network-meta-analyses. Methods We searched MEDLINE/Scopus/EMBASE/ClinicalTrials.gov, up to December 2016, for pediatric RCTs evaluating the immunogenicity and/or safety of 4CMenB ver¬sus its originator-rMenB vaccine or routine-vaccines. We estimated the immunogenicity (antibody titer ≥1:4) against 3 reference strains (44-76/SL; 5/99 and NZ98/254) after the primary immunization course (3 doses for children; 2 doses for adolescents), after one booster dose, and after ≥6 months from primary-course or booster dose (persistence). Results We included 18 studies. One-month post-immunization of children and adolescents, 4CMenB induced seroconversion against all 3 tested strains in > 92% of individuals. Persistence of immunogenicity after primary-course against strain 5-99, 44/76-SL and NZ98-254 was found in 99•6%, 67% and 25•4% children, respectively, with no substantial improvement after one booster dose. There were no deaths, the rates of serious-adverse-events in subjects receiving 4CMenB were low (0.2%) and not significantly different vs rMenB or routine-vaccines. Conclusions With acceptable safety profile, high short-term immunogenicity and adequate-to-high persistence of immunogenicity (against all strains in adolescents and 2 strains in children), 4CMenB may represent a critical instrument to control meningococcal B disease. The clinical significance of the limited persistence of immunogenicity in children against strain NZ98-254 requires further study. Key messages: With acceptable safety profile, high short-term immunogenicity and adequate-to-high persistence of immunogenicity, 4CMenB may represent a critical instrument to control meningococcal B disease. The clinical significance of the limited persistence of immunogenicity in children against strain NZ98-254 requires further study.