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

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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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Acknowledgements

During the peer review process, the manufacturer of MenB-FHbp (Trumenba®) was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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  1. Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Matt Shirley

  2. Unit of Invasive Bacterial Infections, Institut Pasteur, 75015, Paris, France

    Muhamed-Kheir Taha

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Correspondence to Matt Shirley.

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The preparation of this review was not supported by any external funding.

Conflict of interest

Matt Shirley is a salaried employee of Adis/Springer and declares no relevant conflicts of interest. Muhamed-Kheir Taha performs contract work for the Institut Pasteur funded by GSK, Pfizer and Sanofi Pasteur.

Additional information about this Adis Drug Review can be found at: http://www.medengine.com/Redeem/6B4CF0604CD4F8A4.

Additional information

The manuscript was reviewed by: R. Borrow, Vaccine Evaluation Unit, Public Health England, Manchester, UK; M. Petráš, Third Faculty of Medicine, Charles University, Prague, Czech Republic.

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Shirley, M., Taha, MK. MenB-FHbp Meningococcal Group B Vaccine (Trumenba®): A Review in Active Immunization in Individuals Aged ≥ 10 Years. Drugs 78, 257–268 (2018). https://doi.org/10.1007/s40265-018-0869-7

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