成人中雾化或肌内注射5型腺病毒载体新冠病毒疫苗加强剂量的有效性：中国一项多中心、部分随机、平台试验

Effectiveness of a booster dose of aerosolized or intramuscular adenovirus type 5 vectored COVID-19 vaccine in adults: a multicenter, partially randomized, platform trial in China.

作者信息

Jia Siyue, Liu Yuanbao, He Qian, Pan Hongxing, Liang Zhenglun, Zhou Juan, Pan Yingzi, Liu Sheng, Wu Jingjing, Yang Kun, Zhang Xuanxuan, Zhao Yang, Li Simin, Zhang Lei, Chen Li, Yao Aihua, Lu Mengyi, Zhu Fengcai, Mao Qunying, Li Jingxin

机构信息

Jiangsu Provincial Medical Innovation Center, National Health Commission Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, China.

Division of Hepatitis and Enterovirus Vaccines, State Key Laboratory of Drug Regulatory Science, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing, China.

出版信息

Nat Commun. 2025 Mar 26;16(1):2969. doi: 10.1038/s41467-025-58327-y.

We conducted a multicenter, partially randomized, platform trial to assess the effectiveness of a booster dose of an aerosolized or intramuscular adenovirus type 5 vectored COVID-19 vaccine (Ad5-nCoV) in Chinese adults (NCT05855408). Between May 23, 2023, and August 28, 2023, 4089 eligible participants were equally randomized to receive either a booster dose of aerosolized Ad5-nCoV via oral inhalation at 0.1 mL (IH Ad5-nCoV, n = 2039) or an intramuscular injection of Ad5-nCoV at 0.5 mL (IM Ad5-nCoV, n = 2050). Additionally, 2008 participants who declined the booster but consented to participate in COVID-19 surveillance were enrolled in the control group. All participants were monitored for symptomatic COVID-19 over a six-month surveillance period for the primary outcome. From 14 days after the vaccination, 14 (15/1000 person-years), 19 (20/1000 person-years), and 34 (37/1000 person-years) COVID-19 cases were confirmed in the IH Ad5-nCoV group, the IM Ad5-nCoV group, and the control group, respectively, which resulted in an adjusted effectiveness of 52.3% (95% CI 10.4 to 74.6) for IH Ad5-nCoV and 37.2% (95% CI -11.2 to 64.5) for IM Ad5-nCoV. The IH Ad5-nCoV booster was associated with a lower incidence of symptomatic COVID-19, but there is no solid evidence that IH Ad5-nCoV was more effective than IM Ad5-nCoV.

我们开展了一项多中心、部分随机的平台试验，以评估一剂雾化或肌肉注射的5型腺病毒载体新冠疫苗（Ad5-nCoV）加强针在中国成年人中的有效性（NCT05855408）。在2023年5月23日至2023年8月28日期间，4089名符合条件的参与者被等比例随机分组，分别接受0.1毫升经口腔吸入的雾化Ad5-nCoV加强针（吸入式Ad5-nCoV，n = 2039）或0.5毫升肌肉注射的Ad5-nCoV（肌肉注射Ad5-nCoV，n = 2050）。此外，2008名拒绝加强针但同意参与新冠监测的参与者被纳入对照组。在为期六个月的监测期内，对所有参与者进行有症状新冠监测作为主要结局。自接种疫苗14天后，吸入式Ad5-nCoV组、肌肉注射Ad5-nCoV组和对照组分别确诊14例（每1000人年15例）、19例（每1000人年20例）和34例（每1000人年37例）新冠病例，吸入式Ad5-nCoV的调整后有效性为52.3%（95%置信区间10.4%至74.6%），肌肉注射Ad5-nCoV为37.2%（95%置信区间 -11.2%至64.5%）。吸入式Ad5-nCoV加强针与有症状新冠的较低发病率相关，但没有确凿证据表明吸入式Ad5-nCoV比肌肉注射Ad5-nCoV更有效。