MenB-FHbp Meningococcal Group B Vaccine (Trumenba®): A Review in Active Immunization in Individuals Aged ≥ 10 Years.

Abstract:

:MenB-FHbp (bivalent rLP2086; Trumenba®) is a recombinant protein-based vaccine targeting Neisseria meningitidis serogroup B (MenB), which has recently been licensed in the EU for active immunization to prevent invasive disease caused by MenB in individuals ≥ 10 years of age. The vaccine, which contains a variant from each of the two identified subfamilies of the meningococcal surface protein factor H-binding protein (fHBP), has been licensed in the USA for active immunization in individuals 10-25 years of age since 2014. This article reviews the immunogenicity, reactogenicity and tolerability of MenB-FHbp, with a focus on the EU label and the European setting. As demonstrated in an extensive program of clinical trials in adolescents and young adults, a two-dose or three-dose series of MenB-FHbp elicits a strong immune response against a range of MenB test strains selected to be representative of strains prevalent in Europe and the USA. Follow-up studies investigating the persistence of the MenB-FHbp immune response and the effect of a booster dose of the vaccine indicate that a booster dose should be considered (following a primary vaccine series) in individuals at continued risk of invasive meningococcal disease. MenB-FHbp vaccine appears to be moderately reactogenic but, overall, is generally well tolerated, with most adverse reactions being mild to moderate in severity. Although post-marketing, population-based data will be required to establish the true effectiveness of the vaccine, currently available data indicate that MenB-FHbp, in a two-dose or three-dose series, is likely to provide broad protection against MenB strains circulating in Europe.

journal_name

Drugs

journal_title

Drugs

authors

Shirley M,Taha MK

doi

10.1007/s40265-018-0869-7

subject

Has Abstract

pub_date

2018-02-01 00:00:00

pages

257-268

issue

2

eissn

0012-6667

issn

1179-1950

pii

10.1007/s40265-018-0869-7

journal_volume

78

pub_type

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