Chen Jiaqi, Lin Weitong, Yang Chaokai, Lin Wenqi, Cheng Xinghui, He Haoyuan, Li Xinhua, Yu Jingyou
Nanshan School, Guangzhou Medical University, Guangzhou 510180, China.
Guangzhou National Laboratory, Bio-Island, Guangzhou 510005, China.
Vaccines (Basel). 2025 Jul 31;13(8):825. doi: 10.3390/vaccines13080825.
Mucosal vaccines, delivered intranasally or via inhalation, are being studied for respiratory infectious diseases like COVID-19 and influenza. These vaccines aim to provide non-invasive administration and strong immune responses at infection sites, making them a promising area of research. This systematic review and meta-analysis assessed their immunogenicity, safety, and protective efficacy. : The study design was a systematic review and meta-analysis, searching PubMed and Cochrane databases up to 30 May 2025. Inclusion criteria followed the PICOS framework, focusing on mucosal vaccines for COVID-19, influenza, RSV, pertussis, and tuberculosis. A total of 65 studies with 229,614 participants were included in the final analysis. Mucosal COVID-19 vaccines elicited higher neutralizing antibodies compared to intramuscular vaccines (SMD = 2.48, 95% CI: 2.17-2.78 for wild-type; SMD = 1.95, 95% CI: 1.32-2.58 for Omicron), with varying efficacy by route (inhaled VE = 47%, 95% CI: 22-74%; intranasal vaccine VE = 17%, 95% CI: 0-31%). Mucosal influenza vaccines protected children well (VE = 62%, 95% CI: 30-46%, I = 17.1%), but seroconversion rates were lower than those of intramuscular vaccines. RSV and pertussis vaccines had high seroconversion rates (73% and 52%, respectively). Tuberculosis vaccines were reviewed systemically, exhibiting robust cellular immunogenicity. Safety was comparable to intramuscular vaccines or placebo, with no publication bias detected. Current evidence suggests mucosal vaccines are immunogenic, safe, and protective, particularly for respiratory diseases. This review provides insights for future research and vaccination strategies, though limitations include varying efficacy by route and study heterogeneity.
正在研究通过鼻内或吸入方式给药的黏膜疫苗，用于预防如新冠病毒病和流感等呼吸道传染病。这些疫苗旨在实现非侵入性给药，并在感染部位引发强烈的免疫反应，使其成为一个有前景的研究领域。本系统评价和荟萃分析评估了它们的免疫原性、安全性和保护效力。：研究设计为系统评价和荟萃分析，检索截至2025年5月30日的PubMed和Cochrane数据库。纳入标准遵循PICOS框架，重点关注用于新冠病毒病、流感、呼吸道合胞病毒、百日咳和结核病的黏膜疫苗。最终分析纳入了65项研究，共229,614名参与者。与肌内注射疫苗相比，黏膜新冠病毒病疫苗引发了更高的中和抗体（野生型：标准化均数差=2.48，95%置信区间：2.17-2.78；奥密克戎：标准化均数差=1.95，95%置信区间：1.32-2.58），不同给药途径的效力有所不同（吸入式疫苗效力=47%，95%置信区间：22%-74%；鼻内疫苗效力=17%，95%置信区间：0%-31%）。黏膜流感疫苗对儿童有良好的保护作用（效力=62%，95%置信区间：30%-46%，I²=17.1%），但血清转化率低于肌内注射疫苗。呼吸道合胞病毒和百日咳疫苗的血清转化率较高（分别为73%和52%）。对结核病疫苗进行了系统评价，显示出强大的细胞免疫原性。安全性与肌内注射疫苗或安慰剂相当，未检测到发表偏倚。目前的证据表明黏膜疫苗具有免疫原性、安全性和保护作用，尤其是对呼吸道疾病。本综述为未来的研究和疫苗接种策略提供了见解，不过局限性包括不同给药途径的效力差异和研究的异质性。
