Neisseria meningitidis serogroup B bivalent factor H binding protein vaccine

Abstract

With the successful development of meningococcal vaccines against other serogroups, disease caused by Neisseria meningitidis serogroup B now accounts for a disproportionate frequency compared with other serogroups, particularly in the US and Europe. Infants and adolescents bear the highest incidence of disease, which typically manifests as meningitis and septicemia. This vaccine profile article examines a bivalent factor H binding protein (fHbp; also known as LP2086) vaccine that has now been approved by the US FDA for use in 10- to 25-year olds. The manufacturer has shelved plans for further investigation of its use in infants because of high rates of fever in Phase I and II trials in that age group.

Keywords:

• fHbp
• MenB vaccine
• meningococcal vaccine
• rLP2086
• Trumenba

Financial & competing interests disclosure

The authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• The development of a widely effective vaccine against disease caused by Neisseria meningitidis serogroup B (MenB) has been significantly more prolonged compared with other widespread pathogenic serogroups (A, C, W and Y), and currently serogroup B disease accounts for a disproportionate amount of meningococcal disease, with incidence peaks in infants and adolescents.

• A four-component vaccine, 4CMenB (Bexsero, Novartis), has recently been approved in different countries against MenB, for all age ranges.

• This article examines a bivalent factor H binding protein (fHbp) vaccine developed initially by Wyeth (later acquired by Pfizer). fHbp is also known as LP2086.

• The bivalent fHbp vaccine has undergone Phase I and II trials, and Phase III trials are not yet published.

• In a Phase I and II study involving infants (42–90 days old), the trial was terminated early due to unacceptable fever rates.

• In other age ranges up to adults, the safety profile was acceptable.

• Clinical efficacy, from Phase I and II data only, appears to support and suggest good immunogenicity via serum bactericidal activity assays, albeit against a limited range of MenB strains.

• Both the bivalent fHbp and 4CMenB vaccine have the potential to be quite broadly active vaccines, rather than just MenB specific, as their targets are found across the major prevalent serogroups.

• The bivalent fHbp vaccine, as Trumenba, has received in late October 2014 FDA approval to be first vaccine licensed in the USA to prevent MenB disease in individuals 10–25 years of age.