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Randomized Controlled Trial
. 2020 Mar;26(3):454-462.
doi: 10.3201/eid2603.190160.

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

Joanne M Langley, Soren Gantt, Caroline Quach, Julie A Bettinger, Scott A Halperin, Jill Mutch, Shelly A McNeil, Brian J Ward, Donna MacKinnon-Cameron, Lingyun Ye, Kim Marty, David Scheifele, Erin Brown, Joenel Alcantara; Canadian Immunization Research Network
Randomized Controlled Trial

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

Joanne M Langley et al. Emerg Infect Dis. 2020 Mar.

Abstract

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.

Keywords: 4C-MenB; Canada; Neisseria meningitidis serogroup B; adolescents; bacteria; disease outbreaks; humans; meningitis/encephalitis; meningococcal vaccine; meningococcus serogroup B; prevention; student health services; vaccines; young adults.

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Figures

Figure 1
Figure 1
Flowchart of participant inclusion and follow-up for a trial of 4-component protein-based meningococcal B vaccine, Canada.
Figure 2
Figure 2
Reverse cumulative distribution curves of hSBA titers to 3 vaccine strains in recipients in trial of 4-component protein-based meningococcal B vaccine administered at 0 and 21 days compared with 0 and 60 days, Canada. A), B), and C) Comparisons made at day 21. D), E), and F) Comparisons made at day 180. hSBA, human serum bactericidal antibody; hSBA 5/99, Neisserial adhesin A surface proteins; hSBA H44/76, factor H binding protein; hSBA 982/54, New Zealand outer membrane vesicle.
Figure 3
Figure 3
GMTs of hSBA titers to 3 vaccine strains in recipients in trial of 4-component protein-based meningococcal B vaccine administered at 0 and 21 days compared with 0 and 60 days, Canada. A) hSBA 5/99; B) hSBA H44/76; C) hSBA 982/54. Error bars indicate 95% CIs. GMT, geometric mean titer; hSBA, human serum bactericidal antibody; hSBA 5/99, Neisserial adhesin A surface proteins; hSBA H44/76, factor H binding protein; hSBA 982/54, New Zealand outer membrane vesicle.
Figure 4
Figure 4
Percent of participants reporting solicited local and systemic adverse events on day 0 and day 8 after each vaccine dose in trial of 4-component protein-based meningococcal B vaccine, Canada. A-C) Adverse events localized at injection site. D-F) General adverse events. Grade 1: mild, easily tolerated by participant; grade 2: moderate, sufficiently discomforting to interfere with normal everyday activities; grade 3: severe, prevents normal, everyday activities. Error bars indicate 95% CIs.
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References

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