Tartof Sara Y, Aliabadi Negar, Goodwin Gabriella, Slezak Jeff, Hong Vennis, Ackerson Bradley, Liu Qing, Shaw Sally, Welsh Sabrina, Stern Julie A, Kapadia Banshri, Spence Brigitte C, Lewnard Joseph A, Davis Gregg S, Aragones Michael, Dutro Michael, Chilson Erica, Gonzalez Elisa, Hubler Robin, Chia Brandon, Jodar Luis, Gessner Bradford D, Begier Elizabeth
Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.
Pfizer, Inc, Collegeville, Pennsylvania.
JAMA Netw Open. 2024 Dec 2;7(12):e2450832. doi: 10.1001/jamanetworkopen.2024.50832.
Clinical trials have demonstrated high vaccine efficacy (VE) against lower respiratory tract disease (LRTD) but enrolled a smaller proportion of persons aged 75 years or older and those with comorbidities than seen in highest-risk populations in clinical practice settings. Additionally, VE against respiratory syncytial virus (RSV)-related hospitalizations and emergency department (ED) visits is not yet fully described.
To estimate Respiratory Syncytial Virus Prefusion F (RSVpreF) effectiveness in older adults.
DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective case-control study with a test negative design. Cases were adults aged 60 years or older with hospitalizations or ED visits at Kaiser Permanente of Southern California for LRTD from November 24, 2023, to April 9, 2024, who had respiratory swabs collected and tested for RSV. Two control definitions were prespecified: (1) strict controls included RSV-negative LRTD events that were negative for human metapneumovirus, SARS-CoV-2, and influenza, and positive for a nonvaccine preventable cause (primary) and (2) broad controls included all RSV-negative LRTD events (sensitivity analysis). Enhanced specimen collection was conducted to salvage clinical respiratory swabs not tested for RSV during routine care. Data were analyzed from May to September 2024.
RSVpreF vaccine receipt during the first RSV season after licensure and 21 or more days before LRTD event.
Estimated VE against first episode of RSV-related LRTD hospitalization or ED visit.
A total of 7047 LRTD-related hospitalizations or ED encounters with RSV testing results were included. The mean (SD) age was 76.8 (9.6) years; 3819 (54.2%) were female; 839 (11.9%) were non-Hispanic Asian or Pacific Islander, 2323 (33.0%) were Hispanic, 1197 (17.0%) were non-Hispanic Black, and 2602 (36.9%) were non-Hispanic White; 998 (14.2%) were immunocompromised; and 6573 (93.3%) had 1 or more Charlson comorbidity. Using strict controls, estimated adjusted VE was 91% (95% CI, 59%-98%). Using broad controls, estimated adjusted VE was 90% (95% CI, 59%-97%).
In a high-risk, general population, RSVpreF vaccination conferred protection against RSV-related LRTD in the hospital and ED settings among US adults aged 60 years or older, the majority of whom were aged 75 years or older and had comorbidities. These data support use of this vaccine in older adults.
临床试验已证明针对下呼吸道疾病（LRTD）的疫苗效力（VE）很高，但与临床实践中高危人群相比，纳入的75岁及以上人群和合并症患者比例较小。此外，针对呼吸道合胞病毒（RSV）相关住院和急诊科（ED）就诊的疫苗效力尚未完全阐明。
评估呼吸道合胞病毒预融合F（RSVpreF）在老年人中的有效性。
设计、设置和参与者：这是一项采用检测阴性设计的回顾性病例对照研究。病例为2023年11月24日至2024年4月9日在南加州凯撒医疗集团因LRTD住院或到急诊科就诊的60岁及以上成年人，他们采集了呼吸道拭子并进行了RSV检测。预先设定了两种对照定义：（1）严格对照包括人偏肺病毒、SARS-CoV-2和流感检测均为阴性且非疫苗可预防病因检测为阳性的RSV阴性LRTD事件（主要），（2）宽泛对照包括所有RSV阴性LRTD事件（敏感性分析）。进行了强化样本采集，以挽救常规护理期间未检测RSV的临床呼吸道拭子。2024年5月至9月对数据进行了分析。
在RSVpreF疫苗获批后的第一个RSV季节以及LRTD事件发生前21天或更长时间接种RSVpreF疫苗。
评估针对RSV相关LRTD首次住院或急诊科就诊的疫苗效力。
共纳入7047例与LRTD相关的住院或急诊科就诊病例，并获得了RSV检测结果。平均（标准差）年龄为76.8（9.6）岁；3819例（54.2%）为女性；839例（11.9%）为非西班牙裔亚洲人或太平洋岛民，2323例（33.0%）为西班牙裔，1197例（17.0%）为非西班牙裔黑人，2602例（36.9%）为非西班牙裔白人；998例（14.2%）免疫功能低下；6573例（93.3%）有1种或更多查尔森合并症。采用严格对照时，估计调整后的疫苗效力为91%（95%CI，59%-98%）。采用宽泛对照时，估计调整后的疫苗效力为90%（95%CI，59%-97%）。
在高危普通人群中，RSVpreF疫苗接种为60岁及以上美国成年人在医院和急诊科环境中预防RSV相关LRTD提供了保护，其中大多数人年龄在75岁及以上且有合并症。这些数据支持在老年人中使用这种疫苗。
