(HealthDay News) – The multicomponent serogroup B Neisseria meningitidis (MenB) vaccine (4CMenB) is safe and immunogenic for infants when given alone or together with routine vaccinations, according to research published in the Feb. 8 issue of the Journal of the American Medical Association.
Nicoletta Gossger, MD, of the University of Oxford in the United Kingdom, and colleagues conducted a phase 2b randomized, open-label study involving 1,885 infants to determine the immunogenicity and reactogenicity of the 4CMenB vaccine when given alone or in combination with other routine vaccines. The primary outcome measure was achievement of a human complement serum bactericidal activity (hSBA) titer of 1:5 or greater against three serogroup B meningococcal strains of MenB.
The researchers found that 99% of infants who received three 4CMenB vaccinations developed hSBA titers of 1:5 or greater for two of the three strains (44/76-SL and 5/99). For the third strain (NZ98/254), 79% achieved an hSBA titer of 1:5 when administered at months 2, 4, and 6 with routine vaccines; 86.1% when administered at 2, 4, and 6 months without routine vaccines; and 81.7% when given with routine vaccines at 2, 3, and 4 months. A noninferior response was seen for almost all antigens for routine vaccines given with 4CMenB and routine vaccines administered alone.
“4CMenB was immunogenic, generally well tolerated, and showed minimal interference with routine vaccines in the first year of life. The flexibility in schedule allows it to be incorporated into a range of country-specific immunization schedules,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Novartis Vaccines and Diagnostics, which funded the study.