Randomized Trial of 2 Schedules of Meningococcal B Vaccine in Adolescents and Young Adults, Canada¹.

MENINGOCOCCAL vaccines; YOUNG adults; IMMUNIZATION of children; MENINGOCOCCAL infections; NEISSERIA meningitidis; TEENAGERS; ANTI-vaccination movement; PREVENTION of epidemics; RESEARCH; IMMUNIZATION; MEDICAL care for teenagers; RESEARCH methodology; MEDICAL cooperation; EVALUATION research; MEDICAL protocols; COMPARATIVE studies; RANDOMIZED controlled trials; STUDENTS; GRAM-negative aerobic bacteria; UNIVERSITIES & colleges; BLIND experiment; RESEARCH funding; STATISTICAL sampling

CANADA; NEW Zealand

Emergency vaccination programs often are needed to control outbreaks of meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) on college campuses. Such campaigns expend multiple campus and public health resources. We conducted a randomized, controlled, multicenter, observer-blinded trial comparing immunogenicity and tolerability of an accelerated vaccine schedule of 0 and 21 days to a longer interval of 0 and 60 days for 4-component MenB vaccine (MenB-4C) in students 17-25 years of age. At day 21 after the first MenB-4C dose, we observed protective human serum bactericidal titers >4 to MenB strains 5/99, H44/76, and NZ 98/254 in 98%-100% of participants. Geometric mean titers increased >22-fold over baseline. At day 180, >95% of participants sustained protective titers regardless of their vaccine schedule. The most common adverse event was injection site pain. An accelerated MenB-4C immunization schedule could be considered for rapid control of campus outbreaks. [ABSTRACT FROM AUTHOR]

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