目的:关于疗效的系统评价和荟萃分析存在显著的研究空白,免疫原性,呼吸道合胞病毒(RSV)预融合F疫苗的安全性。
方法:我们对PubMed进行了全面搜索,Embase,Cochrane中央受控试验登记册,和ClinicalTrials.gov检索与功效相关的文章,免疫原性,RSV预融合F疫苗的安全性,发布至2023年9月8日。我们遵守系统审查和荟萃分析指南的首选报告项目。
结果:本系统综述和荟萃分析共纳入22项随机对照试验,涉及78,990名参与者。RSV预融合F疫苗对RSV相关急性呼吸道疾病的疫苗有效性为68%(95%CI:59-75%),70%(95%CI:60-77%)与RSV相关的下呼吸道疾病,87%(95%CI:71-94%)针对医疗严重RSV相关下呼吸道疾病。RSV预融合F疫苗接种后常见的局部不良反应包括疼痛,发红,注射部位肿胀,和全身反应,如疲劳,头痛,肌痛,关节痛,恶心,和寒战。
结论:我们的荟萃分析表明,使用RSV融合前F蛋白作为抗原的疫苗表现出广泛可接受的功效,免疫原性,和人口的安全。特别是,它提供了对严重RSV相关的下呼吸道疾病的高保护效率。
OBJECTIVE: A notable research gap exists in the systematic review and meta-analysis concerning the efficacy, immunogenicity, and safety of the respiratory syncytial virus (RSV) prefusion F vaccine.
METHODS: We conducted a comprehensive search across PubMed, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov to retrieve articles related to the efficacy, immunogenicity, and safety of RSV prefusion F vaccines, published through September 8, 2023. We adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
RESULTS: A total of 22 randomized controlled trials involving 78,990 participants were included in this systematic review and meta-analysis. The RSV prefusion F vaccine exhibited a vaccine effectiveness of 68% (95% CI: 59-75%) against RSV-associated acute respiratory illness, 70% (95% CI: 60-77%) against medically attended RSV-associated lower respiratory tract illness, and 87% (95% CI: 71-94%) against medically attended severe RSV-associated lower respiratory tract illness. Common reported local adverse reactions following RSV prefusion F vaccination include pain, redness, and swelling at the injection site, and systemic reactions such as fatigue, headache, myalgia, arthralgia, nausea, and chills.
CONCLUSIONS: Our meta-analysis suggests that vaccines using the RSV prefusion F protein as antigen exhibit appears broadly acceptable efficacy, immunogenicity, and safety in the population. In particular, it provides high protective efficiency against severe RSV-associated lower respiratory tract disease.