呼吸道合胞病毒预融合F蛋白疫苗对患有基础疾病的老年人有效。
Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions.
作者信息
Feldman Robert G, Antonelli-Incalzi Raffaele, Steenackers Katie, Lee Dong-Gun, Papi Alberto, Ison Michael G, Fissette Laurence, David Marie-Pierre, Maréchal Céline, Van der Wielen Marie, Kostanyan Lusine, Hulstrøm Veronica
机构信息
Senior Clinical Trials Inc., Laguna Hills, California, USA.
Department of Internal Medicine and Geriatrics, Università Campus Bio-Medico di Roma, Rome, Italy.
出版信息
Clin Infect Dis. 2024 Jan 25;78(1):202-209. doi: 10.1093/cid/ciad471.
BACKGROUND
Older adults with chronic cardiorespiratory or endocrine/metabolic conditions are at increased risk of respiratory syncytial virus (RSV)-related acute respiratory illness (RSV-ARI) and severe respiratory disease. In an ongoing, randomized, placebo-controlled, multicountry, phase 3 trial in ≥60-year-old participants, an AS01E-adjuvanted RSV prefusion F protein-based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD), severe RSV-LRTD, and RSV-ARI. We evaluated efficacy and immunogenicity among participants with coexisting cardiorespiratory or endocrine/metabolic conditions that increase the risk of severe RSV disease ("conditions of interest").
METHODS
Medically stable ≥60-year-old participants received 1 dose of RSVPreF3 OA or placebo. Efficacy against first RSV-LRTD and RSV-ARI episodes was assessed in subgroups with/without coexisting cardiorespiratory or endocrine/metabolic conditions of interest. Immunogenicity was analyzed post hoc in these subgroups.
RESULTS
In total, 12 467 participants received RSVPreF3 OA and 12 499 received placebo. Of these, 39.6% (RSVPreF3 OA) and 38.9% (placebo) had ≥1 coexisting condition of interest. The median efficacy follow-up was 6.7 months. Efficacy against RSV-LRTD was high in participants with ≥1 condition of interest (94.6%), ≥1 cardiorespiratory (92.1%), ≥1 endocrine/metabolic (100%), and ≥2 conditions of interest (92.0%). Efficacy against RSV-ARI was 81.0% in participants with ≥1 condition of interest (88.1% for cardiorespiratory, 79.4% for endocrine/metabolic conditions) and 88.0% in participants with ≥2 conditions of interest. Postvaccination neutralizing titers were at least as high in participants with ≥1 condition of interest as in those without.
CONCLUSIONS
RSVPreF3 OA was efficacious against RSV-LRTD and RSV-ARI in older adults with coexisting medical conditions associated with an increased risk of severe RSV disease.
CLINICAL TRIALS REGISTRATION
ClinicalTrials.gov: NCT04886596.
背景
患有慢性心肺或内分泌/代谢疾病的老年人发生呼吸道合胞病毒（RSV）相关急性呼吸道疾病（RSV-ARI）和严重呼吸道疾病的风险增加。在一项正在进行的、随机、安慰剂对照、多国、3期试验中，入组年龄≥60岁的参与者，一种基于AS01E佐剂的RSV预融合F蛋白疫苗（RSVPreF3 OA）对RSV相关下呼吸道疾病（RSV-LRTD）、严重RSV-LRTD和RSV-ARI有效。我们评估了存在增加严重RSV疾病风险的心肺或内分泌/代谢共存疾病（“相关疾病”）的参与者中的疫苗效力和免疫原性。
方法
病情医学稳定的≥60岁参与者接受1剂RSVPreF3 OA或安慰剂。在有/无相关心肺或内分泌/代谢共存疾病的亚组中评估对首次RSV-LRTD和RSV-ARI发作的效力。对这些亚组进行事后免疫原性分析。
结果
共有12467名参与者接受RSVPreF3 OA，12499名接受安慰剂。其中，39.6%（RSVPreF3 OA）和38.9%（安慰剂）有≥1种相关共存疾病。效力随访的中位数为6.7个月。在有≥1种相关疾病（94.6%）、≥1种心肺疾病（92.1%）、≥1种内分泌/代谢疾病（100%）和≥2种相关疾病（92.0%）的参与者中，对RSV-LRTD的效力较高。在有≥1种相关疾病的参与者中，对RSV-ARI的效力为81.0%（心肺疾病为88.1%，内分泌/代谢疾病为79.4%），在有≥2种相关疾病的参与者中为88.0%。接种疫苗后的中和抗体滴度在有≥1种相关疾病的参与者中至少与无相关疾病的参与者一样高。
结论
RSVPreF3 OA对患有与严重RSV疾病风险增加相关的共存疾病的老年人的RSV-LRTD和RSV-ARI有效。
临床试验注册
ClinicalTrials.gov：NCT04886596。
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