From research to licensure and beyond: clinical development of MenB-FHbp, a broadly protective meningococcal B vaccine

ABSTRACT

Introduction: Given the characteristics of meningococcal carriage and transmission and the sudden, often severe onset and long-term consequences of disease, vaccination can most effectively provide large-scale control of invasive disease. Six serogroups (A, B, C, W, X, and Y) cause nearly all meningococcal disease globally. Capsular polysaccharide conjugate vaccines can prevent serogroups A, C, W, and Y disease. More recently, recombinant protein vaccines for preventing serogroup B meningococcal (MenB) disease have become available, with a major target of vaccine-induced immune response for both vaccines being bacterial factor H binding protein (FHbp). Importantly, FHbp segregates into only two distinct subfamilies (A [also classified as variants 2 and 3] and B [variant 1]). This review summarizes the complete clinical development program supporting licensure of MenB-FHbp (Trumenba®, Bivalent rLP2086), the only MenB vaccine containing antigens from both FHbp subfamilies.

Areas covered: Eleven published clinical studies assessing MenB-FHbp efficacy and safety among 20,803 adolescents and adults are examined. Particular focus is on the methodology of immunogenicity assessments used as a surrogate for clinical efficacy.

Expert commentary: Clinical studies in adolescents and adults consistently demonstrated MenB-FHbp safety and induction of immunologic responses against antigenically and epidemiologically diverse MenB isolates, supporting licensure and immunization recommendations.

KEYWORDS:

• Bivalent rLP2086
• factor H binding protein
• MenB-FHbp
• meningococcal serogroup B disease
• Trumenba®
• vaccine coverage

Acknowledgments

Medical writing support was provided by Nicole Gudleski O’Regan, PhD, and Judith Kandel, PhD, at Complete Healthcare Communications, LLC (West Chester, PA), a CHC Group Company, and was funded by Pfizer Inc. This publication made use of the Neisseria Multi Locus Sequence Typing website (https://pubmlst.org/neisseria/) developed by Keith Jolley [101] and sited at the University of Oxford. The development of the site has been funded by the Wellcome Trust and European Union.

Declaration of interest

All authors are current or former employees of Pfizer and may hold stock options. In addition, Pfizer Inc is the assignee for US Patent 9561269 and pending US patent publication US20150071. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

One reviewer of the manuscript disclosed employment with GSK Vaccines and participation in the development of 4CMenB, the other protein-based vaccine currently licensed for prevention of MenB disease.

Supplementary Material

Supplemental data for this article can be accessed here.

Additional information

Funding

These studies were supported by Pfizer Inc.