1. Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults.
- Author
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Walsh, E. E., Marc, G. Pérez, Zareba, A. M., Falsey, A. R., Jiang, Q., Patton, M., Polack, F. P., Llapur, C., Doreski, P. A., Ilangovan, K., Rämet, M., Fukushima, Y., Hussen, N., Bont, L. J., Cardona, J., DeHaan, E., Castillo Villa, G., Ingilizova, M., Eiras, D., and Mikati, T.
- Subjects
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OLDER people , *CLINICAL trials , *VACCINE effectiveness , *RESPIRATORY syncytial virus , *INTRAMUSCULAR injections , *HUMAN metapneumovirus infection - Abstract
BACKGROUND Respiratory syncytial virus (RSV) infection causes considerable illness in older adults. The efficacy and safety of an investigational bivalent RSV prefusion F protein—based (RSVpreF) vaccine in this population are unknown. METHODS In this ongoing, phase 3 trial, we randomly assigned, in a 1:1 ratio, adults (260 years of age) to receive a single intramuscular injection of RSVpreF vaccine at a dose of 120 pg (RSV subgroups A and B, 60 itg each) or placebo. The two primary end points were vaccine efficacy against seasonal RSV-associated lower respiratory tract illness with at least two or at least three signs or symptoms. The secondary end point was vaccine efficacy against RSV-associated acute respiratory illness. RESULTS At the interim analysis (data-cutoff date, July 14, 2022), 34,284 participants had received RSVpreF vaccine (17,215 participants) or placebo (17,069 participants). RSV-associated lower respiratory tract illness with at least two signs or symptoms occurred in 11 participants in the vaccine group (1.19 cases per 1000 person-years of observation) and 33 participants in the placebo group (3.58 cases per 1000 person-years of observation) (vaccine efficacy, 66.7%; 96.66% confidence interval [CI], 28.8 to 85.8); 2 cases (0.22 cases per 1000 person-years of observation) and 14 cases (1.52 cases per 1000 person-years of observation), respectively, occurred with at least three signs or symptoms (vaccine efficacy, 85.7%; 96.66% CI, 32.0 to 98.7). RSV-associated acute respiratory illness occurred in 22 participants in the vaccine group (2.38 cases per 1000 person-years of observation) and 58 partici-pants in the placebo group (6.30 cases per 1000 person-years of observation) (vac-cine efficacy, 62.1%; 95% CI, 37.1 to 77.9). The incidence of local reactions was higher with vaccine (12%) than with placebo (7%); the incidences of systemic events were similar (27% and 26%, respectively). Similar rates of adverse events through 1 month after injection were reported (vaccine, 9.0%; placebo, 8.5%), with 1.4% and 1.0%, respectively, considered by the investigators to be injection-related. Severe or life-threatening adverse events were reported in 0.5% of vaccine recipients and 0.4% of placebo recipients. Serious adverse events were reported in 2.3% of participants in each group through the data-cutoff date. CONCLUSIONS RSVpreF vaccine prevented RSV-associated lower respiratory tract illness and RSV-associated acute respiratory illness in adults (260 years of age), without evident safety concerns. (Funded by Pfizer; RENOIRClinicalTrials.gov number, NCT05035212; EudraCT number, 2021-003693-31.) [ABSTRACT FROM AUTHOR]
- Published
- 2023
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