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Persistence of hSBA titers elicited by the meningococcal serogroup B vaccine menB-FHbp for up to 4 years after a 2- or 3-dose primary series and immunogenicity, safety, and tolerability of a booster dose through 26 months
L. Østergaard, T. Vesikari, SD. Senders, CE. Flodmark, P. Kosina, HQ. Jiang, JD. Maguire, J. Absalon, KU. Jansen, SL. Harris, R. Maansson, P. Balmer, J. Beeslaar, JL. Perez
Language English Country Netherlands
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 2002-01-01 to 2 months ago
Nursing & Allied Health Database (ProQuest)
from 2002-01-01 to 2 months ago
Health & Medicine (ProQuest)
from 2002-01-01 to 2 months ago
Family Health Database (ProQuest)
from 2002-01-01 to 2 months ago
Health Management Database (ProQuest)
from 2002-01-01 to 2 months ago
Public Health Database (ProQuest)
from 2002-01-01 to 2 months ago
- MeSH
- Immunogenicity, Vaccine MeSH
- Humans MeSH
- Meningococcal Infections * prevention & control MeSH
- Meningococcal Vaccines * adverse effects MeSH
- Adolescent MeSH
- Neisseria meningitidis, Serogroup B * MeSH
- Antibodies, Bacterial MeSH
- Serogroup MeSH
- Check Tag
- Humans MeSH
- Adolescent MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: To demonstrate extended protection against meningococcal serogroup B (MenB) disease after MenB-FHbp (bivalent rLP2086) vaccination, this study evaluated immunopersistence through 26 months following MenB-FHbp boosting after 2 or 3 primary doses in adolescents. STUDY DESIGN: This phase 3, open-label study was an extension of 3 phase 2 studies with participants aged 11-18 years randomized to receive primary MenB-FHbp vaccination following 1 of 5 dosing schedules or control. A booster dose was administered 48 months after the primary series. Immunopersistence through 48 months after the last primary dose (persistence stage) and 26 months postbooster (booster stage) was determined by serum bactericidal assays using human complement (hSBAs) against 4 vaccine-heterologous test strains. Safety evaluations included adverse events (AEs) and local and systemic reactions. RESULTS: Overall, 698 and 304 subjects enrolled in the persistence and booster stages, respectively. hSBA titers declined in all groups during 12 months postprimary vaccination, then remained stable through 48 months. One month postbooster, 93.4-100.0% of subjects achieved hSBA titers ≥ lower limit of quantitation against each test strain; percentages at 12 and 26 months postbooster were higher than at similar time points following primary vaccination. Primary and booster MenB-FHbp vaccinations were well tolerated, with ≤ 12.5% of subjects reporting AEs during each stage. The most common local (reported by 84.4-93.8% of subjects) and systemic (68.8-76.6%) reactions to the booster were injection site pain and fatigue and headache, respectively; ≤ 3.7% of subjects reported severe systemic events. CONCLUSION: Protective hSBA titers initially declined but were retained by many subjects for 4 years irrespective of primary MenB-FHbp vaccination schedule. Boosting at 48 months after primary vaccination was safe, well tolerated, and induced immune responses indicative of immunological memory that persisted through 26 months. Booster vaccination during late adolescence may prolong protection against MenB disease.
Department of Pediatrics Entrance 108 Skåne University Hospital in Malmö 205 02 Malmö Sweden
Nordic Research Network Ltd Biokatu 10 33520 Tampere Finland
Pfizer UK Vaccine Research and Development Horizon Building Honey Lane Hurley SL6 6RJ UK
Pfizer Vaccine Medical and Scientific Affairs 500 Arcola Road Collegeville PA USA
Pfizer Vaccine Research and Development 401 North Middletown Road Pearl River NY USA
Pfizer Vaccine Research and Development 500 Arcola Road Collegeville PA USA
Senders Pediatrics 2054 South Green Road South Euclid OH USA
References provided by Crossref.org
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