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Drugs

01.02.2018 | Adis Drug Evaluation

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

verfasst von: Matt Shirley, Muhamed-Kheir Taha

Erschienen in: Drugs | Ausgabe 2/2018

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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.
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Metadaten
Titel
MenB-FHbp Meningococcal Group B Vaccine (Trumenba®): A Review in Active Immunization in Individuals Aged ≥ 10 Years
verfasst von
Matt Shirley
Muhamed-Kheir Taha
Publikationsdatum
01.02.2018
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 2/2018
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-018-0869-7