Respiratory syncytial virus vaccine effectiveness among US veterans, September, 2023 to March, 2024: a target trial emulation study

作     者：Bajema, Kristina L Yan, Lei Li, Yuli Argraves, Stephanie Rajeevan, Nallakkandi Fox, Alexandra Vergun, Robert Berry, Kristin Bui, David Huang, Yuan Lin, Hung-Mo Hynes, Denise M Lucero-Obusan, Cynthia Schirmer, Patricia Cunningham, Francesca Huang, Grant D Aslan, Mihaela Ioannou, George N 

作者机构：Veterans Affairs Portland Health Care System Portland OR United States Division of Infectious Diseases Department of Medicine Oregon Health & Science University Portland OR United States Veterans Affairs Cooperative Studies Program Clinical Epidemiology Research Center Veterans Affairs Connecticut Health Care System West Haven CT United States Department of Biostatistics Yale School of Public Health New Haven CT United States Biomedical Informatics & Data Science Yale School of Medicine New Haven CT United States Department of Internal Medicine Yale School of Medicine New Haven CT United States Seattle Epidemiologic Research and Information Center Veterans Affairs Puget Sound Health Care System Seattle WA United States Research and Development Veterans Affairs Puget Sound Health Care System Seattle WA United States Center of Innovation to Improve Veteran Involvement in Care Veterans Affairs Portland Health Care System Portland OR United States Health Management and Policy College of Health Oregon State University Corvallis OR United States Health Data and Informatics Program Center for Quantitative Life Sciences Oregon State University Corvallis OR United States Public Health National Program Office Veterans Health Administration Palo Alto CA United States Public Health National Program Office Veterans Health Administration Washington DC United States Veterans Affairs Center for Medication Safety—Pharmacy Benefit Management Services Hines IL United States Office of Research and Development Veterans Health Administration Washington DC United States Division of Gastroenterology Veterans Affairs Puget Sound Health Care System and University of Washington Seattle WA United States 

出 版 物：《The Lancet Infectious Diseases》 (Lancet Infect. Dis.)

年 卷 期：2025年第25卷第6期

页      面：625-633页

学科分类：1004[医学-公共卫生与预防医学(可授医学、理学学位)] 1002[医学-临床医学] 1001[医学-基础医学(可授医学、理学学位)] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：U.S. Department of Veterans Affairs, USDVA US Department of Health and Human Services Biomedical Advanced Research and Development Authority, (AAI21050) U.S. Food and Drug Administration, FDA, (75F40121S30013) U.S. Food and Drug Administration, FDA 

摘      要：Background: New respiratory syncytial virus (RSV) vaccines have been approved in the USA for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 years and older. Information on the real-world effectiveness of these vaccines is needed. Methods: We used electronic health records in the Veterans Health Administration to emulate a target trial comparing a single dose of a recombinant stabilised prefusion F protein RSV vaccine versus no vaccination among veterans aged 60 years and older. We matched eligible vaccine recipients with up to four unvaccinated individuals in four monthly nested sequential trials from Sept 1 to Dec 31, 2023. Outcomes were ascertained up to March 31, 2024. The primary outcome was any positive RSV test from day 14 following the matched index date. Secondary outcomes included hospitalisation and emergency department or urgent care encounter occurring within 1 day before or after a positive RSV test. We estimated vaccine effectiveness as 100 × (1 – risk ratio). Findings: We included 146 852 vaccinated individuals matched to 582 936 unique control individuals, weighted equally to represent 146 852 individuals. Across the two groups, 276 039 (94·0%) of 293 704 veterans were male, 17 665 (6·0%) were female, and median age was 75·9 years (IQR 71·7–79·7). Over a median follow-up of 124 days (IQR 102–150), the incidence rate of documented RSV infection was 1·7 (95% CI 1·4–2·1) events per 1000 person-years (88 total events) in the vaccinated group and 7·3 (6·6–8·1) per 1000 person-years in the unvaccinated group (372 total events), and vaccine effectiveness was estimated as 78·1% (72·6–83·5). Among the secondary outcomes, vaccine effectiveness was estimated at 78·7% (72·2–84·8) against RSV-associated emergency department or urgent care encounters, and 80·3% (65·8–90·1) against RSV-associated hospitalisation. Interpretation: RSV vaccination was effective in preventing RSV-related illness, including associated health-care use,