A phase 3 study to assess the immunogenicity, safety, and tolerability of MenB-FHbp administered as a 2-dose schedule in adolescents and young adults.

Autor: Drazan D; General Practice for Children and Adolescents, Jindrichuv Hradec, Czech Republic., Czajka H; Faculty of Medicine, University of Rzeszów, Rzeszów, Poland and Individual Specialist Medical Practice, Krakow, Poland., Maguire JD; Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. Electronic address: Jason.Maguire@pfizer.com., Pregaldien JL; Vaccine Research and Development, Pfizer Inc, Brussels, Belgium., Maansson R; Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA., O'Neill R; Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA., Anderson AS; Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA., Balmer P; Vaccine Medical and Scientific Affairs, Pfizer Inc, Collegeville, PA, USA., Beeslaar J; Vaccine Clinical Research and Development, Pfizer UK, Hurley, UK., Perez JL; Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2022 Jan 21; Vol. 40 (2), pp. 351-358. Date of Electronic Publication: 2021 Dec 24.
DOI: 10.1016/j.vaccine.2021.11.053
Abstrakt: Background: The MenB-FHbp vaccine is licensed to prevent meningococcal serogroup B disease on either a 2-dose (0, 6 months) or 3-dose (0, 1-2, 6 months) series. This phase 3 study further assessed the immunogenicity and safety of the 2-dose MenB-FHbp schedule.
Methods: Subjects 10-25 years of age received MenB-FHbp (months 0, 6) and the quadrivalent meningococcal conjugate vaccine MenACWY-CRM (month 0). Primary immunogenicity endpoints included percentages of subjects achieving ≥ 4-fold increases from baseline in serum bactericidal antibody using human complement (hSBA) titers for 4 diverse, vaccine-heterologous primary serogroup B test strains and titers ≥ lower limit of quantitation (LLOQ; 1:8 or 1:16) for all 4 primary strains combined (composite response) after dose 2; a titer ≥ 1:4 is the accepted correlate of protection. Percentages of participants with hSBA titers ≥ LLOQ for 10 additional vaccine-heterologous strains were also assessed; positive predictive values of primary strain responses for secondary strain responses were determined. Safety was assessed.
Results: Overall, 1057 subjects received dose 1 and 946 received dose 2 of MenB-FHbp. Percentages of participants achieving ≥ 4-fold increases in hSBA titers against each primary strain after dose 2 ranged from 67.4% to 95.0% and the composite response was 74.3%. Primary strain responses were highly predictive of secondary strain responses. Most reactogenicity events were mild-to-moderate in severity and did not lead to withdrawal from the study. Adverse events (AEs) considered by the investigator to be related to vaccination occurred in 4.2% (44/1057) of subjects, and there were no serious AEs or newly diagnosed chronic medical conditions considered related to vaccination.
Conclusions: MenB-FHbp administered at 0, 6 months was well tolerated and induced protective bactericidal antibody responses against diverse serogroup B strains. Findings provide further support for the continued use of MenB-FHbp on a 2-dose schedule in this population.
Competing Interests: Declaration of Competing Interest Daniel Drazan and Hanna Czajka are investigators in Pfizer clinical studies. All other authors are current employees of Pfizer and may hold stock or stock options in the company.
(Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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