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

• Published in: Emerging infectious diseases 2020-03, Vol.26 (3), p.454-462
• Main Authors: Langley, Joanne M, Gantt, Soren, Quach, Caroline, Bettinger, Julie A, Halperin, Scott A, Mutch, Jill, McNeil, Shelly A, Ward, Brian J, MacKinnon-Cameron, Donna, Ye, Lingyun, Marty, Kim, Scheifele, David, Brown, Erin, Alcantara, Joenel
• Format: Article
• Language: English
• Subjects: Aluminum; Antigens; Clinical trials; College campuses; Colleges & universities; Comparative analysis; disease outbreaks; disease prevention; Diseases; Drug dosages; Epidemics; FDA approval; Hepatitis; humans; Meningitis; Meningococcal infections; Meningococcal vaccines; Neisseria meningitidis Group B; Prevention; Proteins; Public health; Public health movements; Schedules; Social research; Teenagers; Vaccination; Vaccines; Young adults
• ISSN: 1080-6040; 1080-6059
• DOI: 10.3201/eid2603.190160

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.