Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination.

RSVpreF immunogenicity neutralizing responses respiratory syncytial virus safety vaccine

Journal

The Journal of infectious diseases
ISSN: 1537-6613
Titre abrégé: J Infect Dis
Pays: United States
ID NLM: 0413675

Informations de publication

Date de publication:
12 Apr 2024
Historique:
received: 15 12 2023
revised: 27 03 2024
accepted: 05 04 2024
medline: 12 4 2024
pubmed: 12 4 2024
entrez: 12 4 2024
Statut: aheadofprint

Résumé

Respiratory syncytial virus (RSV) causes substantial respiratory disease. Bivalent RSV prefusion F (RSVpreF) vaccine is licensed in ≥60-year-olds. RSVpreF was well-tolerated and immunogenic in a phase 1/2 study. We evaluated antibody persistence after initial vaccination and safety and immunogenicity after revaccination from this study. Healthy adults were randomized to receive both initial vaccination and revaccination 12 months later with either placebo or RSVpreF 240 µg (±Al(OH)3). RSV-A and RSV-B geometric mean neutralizing titers (GMTs) were measured through 12 months after both vaccinations. Tolerability/safety was assessed. There were 263 participants revaccinated (18-49-years-old, n=134; 65-85-years-old, n=129). Among 18-49-year-olds and 65-85-year-olds, respectively, geometric mean fold rises (GMFRs) for both RSV subgroups (RSV-A; RSV-B) 1 month after initial RSVpreF vaccination were 13.3-20.4 and 8.9-15.5 compared with levels before initial vaccination; corresponding GMFRs 12 months after initial vaccination were 4.1-5.0 and 2.6-4.1. GMFRs 1 month after revaccination compared with levels before revaccination were 1.4-2.3 and 1.4-2.2 for 18-49-year-olds and 65-85-year-olds, respectively. Peak GMTs after revaccination were lower than those after initial vaccination. GMTs 12 months after initial vaccination and revaccination were similar, with GMFRs ranging from 0.7-1.6. No safety signals occurred. RSVpreF revaccination was immunogenic and well-tolerated among adults. NCT03529773.

Sections du résumé

BACKGROUND BACKGROUND
Respiratory syncytial virus (RSV) causes substantial respiratory disease. Bivalent RSV prefusion F (RSVpreF) vaccine is licensed in ≥60-year-olds. RSVpreF was well-tolerated and immunogenic in a phase 1/2 study. We evaluated antibody persistence after initial vaccination and safety and immunogenicity after revaccination from this study.
METHODS METHODS
Healthy adults were randomized to receive both initial vaccination and revaccination 12 months later with either placebo or RSVpreF 240 µg (±Al(OH)3). RSV-A and RSV-B geometric mean neutralizing titers (GMTs) were measured through 12 months after both vaccinations. Tolerability/safety was assessed.
RESULTS RESULTS
There were 263 participants revaccinated (18-49-years-old, n=134; 65-85-years-old, n=129). Among 18-49-year-olds and 65-85-year-olds, respectively, geometric mean fold rises (GMFRs) for both RSV subgroups (RSV-A; RSV-B) 1 month after initial RSVpreF vaccination were 13.3-20.4 and 8.9-15.5 compared with levels before initial vaccination; corresponding GMFRs 12 months after initial vaccination were 4.1-5.0 and 2.6-4.1. GMFRs 1 month after revaccination compared with levels before revaccination were 1.4-2.3 and 1.4-2.2 for 18-49-year-olds and 65-85-year-olds, respectively. Peak GMTs after revaccination were lower than those after initial vaccination. GMTs 12 months after initial vaccination and revaccination were similar, with GMFRs ranging from 0.7-1.6. No safety signals occurred.
CONCLUSIONS CONCLUSIONS
RSVpreF revaccination was immunogenic and well-tolerated among adults. NCT03529773.

Identifiants

pubmed: 38606958
pii: 7644684
doi: 10.1093/infdis/jiae185
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT03529773']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Auteurs

Edward E Walsh (EE)

Department of Medicine, Infectious Diseases Division, Rochester General Hospital and University of Rochester Medical Center, Rochester, NY, 14642, USA.

Ann R Falsey (AR)

Department of Medicine, Infectious Diseases Division, Rochester General Hospital and University of Rochester Medical Center, Rochester, NY, 14642, USA.

Agnieszka M Zareba (AM)

Vaccine Research and Development, Pfizer Inc, Collegeville, PA, 19426, USA.

Qin Jiang (Q)

Vaccine Research and Development, Pfizer Inc, Collegeville, PA, 19426, USA.

Alejandra Gurtman (A)

Vaccine Research and Development, Pfizer Inc, Pearl River, NY, 10965, USA.

David Radley (D)

Vaccine Research and Development, Pfizer Inc, Pearl River, NY, 10965, USA.

Emily Gomme (E)

Vaccine Research and Development, Pfizer Inc, Pearl River, NY, 10965, USA.

David Cooper (D)

Vaccine Research and Development, Pfizer Inc, Pearl River, NY, 10965, USA.

Kathrin U Jansen (KU)

Vaccine Research and Development, Pfizer Inc, Pearl River, NY, 10965, USA.

William C Gruber (WC)

Vaccine Research and Development, Pfizer Inc, Pearl River, NY, 10965, USA.

Kena A Swanson (KA)

Vaccine Research and Development, Pfizer Inc, Pearl River, NY, 10965, USA.

Beate Schmoele-Thoma (B)

Vaccine Research and Development, Pfizer Pharma GmbH, Berlin, 10785, Germany.

Classifications MeSH