The multicomponent meningococcal serogroup B vaccine (4CMenB) has an acceptable short-term safety profile and achieves a satisfactory immune response 30 days post-vaccination in children and adolescents, according to research published in the Lancet Infectious Diseases.
Data from 10 randomized trials and 8 follow-on extension trials, which included patients age ≤18, comparing immunogenicity and safety of the 4CMenB vaccine with the original meningococcal B recombinant vaccine against 1 of 4 Neisseria meningitidis serogroup B reference strains (44-76/SL, 5/99, NZ98/254, and M10713) were reviewed.
Overall the percentage of children and adolescents who achieved seroconversion 30 days post-primary course 4CMenB was 92% (95% CI, 89 to 95 [I2=95%, P <.0001]) for the 44/76-SL strain, 91% (87 to 95 [I2=95%, P <.0001]) for the 5/99 strain, 84% (77 to 90 [I2=97%, P <.0001]) for the NZ98-254 strain, and 87% (68 to 99 [I2=97%, P <.0001]) for the M10713 strain.
Six months post-primary course, immunogenicity remained high (≥77%) in adolescents against 3 strains (5/99, 44/76-SL, and NZ98/254) and adequate (≥67%) in children against 2 strains (5/99 and 44/76-SL). The immunogenicity against strains M10713 and NZ98/254 declined 6 months post <50% and <35%, respectively.
Booster doses restored the percentage of patients achieving seroconversion against all strains to ≥93%. This result was sustained 6 months post-booster only for the 5/99 (95%) and M10713 (75%) strains, while immunogenicity against the remaining strains returned to pre-booster levels.
Incidence of acute, serious, adverse vaccine-related events in patients receiving 4CMenB was low (5.4 per 1000 individuals) but significantly higher than the 1.2 per 1000 individual rates reported for routine vaccines.
Investigators concluded that 4CMenB has an acceptable short-term safety profile but did note that the analysis suffers from potential sponsorship bias and a lack of evidence in adolescents, especially on persistence of immunogenicity after a booster dose, as well as long-term follow up data. They further recommend that “additional studies, preferably non-industry sponsored, are needed to support the long-term safety and efficacy of 4CMenB.”
Flacco ME, Manzoli L, Rosso A, et al. Immunogenicity and safety of the multicomponent meningococcal B vaccine (4CMenB) in children and adolescents: a systematic review and meta-analysis [published online January 19, 2018]. Lancet Infect Dis. doi:10.1016/S1473-3099(18)30048-3