| Autor: |
Beate Schmoele-Thoma, Agnieszka M. Zareba, Qin Jiang, Mohan S. Maddur, Rana Danaf, Alex Mann, Kingsley Eze, Juin Fok-Seang, Golam Kabir, Andrew Catchpole, Daniel A. Scott, Alejandra C. Gurtman, Kathrin U. Jansen, William C. Gruber, Philip R. Dormitzer, Kena A. Swanson |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
The New England journal of medicine. 386(25) |
| ISSN: |
1533-4406 |
| Popis: |
Although human respiratory syncytial virus (RSV) is an important cause of illness and death in older adults, no RSV vaccine has been licensed.In a phase 2a study, we randomly assigned healthy adults (18 to 50 years of age), in a 1:1 ratio, to receive a single intramuscular injection of either bivalent prefusion F (RSVpreF) vaccine or placebo. Approximately 28 days after injection, participants were inoculated intranasally with the RSV A Memphis 37b challenge virus and observed for 12 days. The per-protocol prespecified primary end points were the following: reverse-transcriptase-quantitative polymerase-chain-reaction (RT-qPCR)-confirmed detectable RSV infection on at least 2 consecutive days with at least one clinical symptom of any grade from two categories or at least one grade 2 symptom from any category, the total symptom score from day 1 to discharge, and the area under the curve (AUC) for the RSV viral load in nasal-wash samples measured by means of RT-qPCR from day 2 after challenge to discharge. In addition, we assessed immunogenicity and safety.After participants were inoculated with the challenge virus, vaccine efficacy of 86.7% (95% CI, 53.8 to 96.5) was observed for symptomatic RSV infection confirmed by any detectable viral RNA on at least 2 consecutive days. The median AUC for the RSV viral load (hours × logRSVpreF vaccine was effective against symptomatic RSV infection and viral shedding. No evident safety concerns were identified. These findings provide support for further evaluation of RSVpreF vaccine in a phase 3 efficacy study. (Funded by Pfizer; EudraCT number, 2020-003887-21; ClinicalTrials.gov number, NCT04785612.). |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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