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

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

Disclosures

Emerging Infectious Diseases. 2020;26(3):454-462. 

In This Article

Abstract and Introduction

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.

Introduction

Campus outbreaks of meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) are rare, but case-fatality rates are 5.3%–10.0%, and 10%–20% of survivors have long-term health effects.[1] In addition, MenB outbreaks cause public distress and anxiety.[2] Enhanced person-to-person transmission among young persons living in close quarters and having close social contacts on college campuses is thought to increase risk of outbreaks.[3] During 2008–2017, a total of 12 campus-based clusters of MenB occurred at residential universities in North America,[4] 11 in the United States[4] and 1 in Canada.[5]

The public health response to a MenB outbreak includes education about prevention and early recognition of disease, antimicrobial drug prophylaxis for close contacts, and either preexposure or early postexposure vaccination.[3] Two MenB vaccines are now available, a 4-component protein-based vaccine (MenB-4C [Bexsero; GlaxoSmithKline, https://www.gsk.com]) and a bivalent factor H binding protein-based vaccine (MenB-FHbp [Trumenba; Pfizer Inc., https://www.pfizer.com]). In Canada, MenB-4C was approved for use in 2013 for persons 2 months–17 years of age. MenB-4C is given as 2 doses ≥1 month apart.[6] MenB-FHbp was authorized in 2017 and is given as 3 doses at 0, 1–2, and 6 months, or 2 doses 6 months apart. During MenB outbreaks, MenB-4C has been administered in 2 doses at varying schedules, including 0 and 30 days, 0 and 6–8 weeks, 0 and 2 months, and 0 and 10 weeks.[7–9] However, few controlled studies have investigated the immunogenicity and reactogenicity of MenB-4C in older adolescents and young adults to compare various vaccination schedules.[10–13]

Management of organization-based outbreaks on college campuses demands considerable resources,[3,14] and disease transmission must be interrupted quickly. A shorter dosing schedule might provide more rapid individual direct protection and be easier to schedule around exams and school breaks. When MenB-4C vaccine was authorized in Canada, public health stakeholders identified a need to assess shorter dosing schedules for outbreak control to reduce the strain on public health resources by implementing the vaccine campaign in a single condensed period instead of 2 separate deployments. In a study supported by the Canadian Immunization Research Network (CIRN), we compared immunogenicity and tolerability of an accelerated MenB-4C vaccine schedule of 2 doses at 0 and 21 days to a longer interval of 0 and 60 days to facilitate outbreak control.

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