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

Siyue Jia, Yuanbao Liu, Qian He, Hongxing Pan, Zhenglun Liang, Juan Zhou, Yingzi Pan, Sheng Liu, Jingjing Wu, Kun Yang, Xuanxuan Zhang, Yang Zhao, Simin Li, Lei Zhang, Li Chen, Aihua Yao, Mengyi Lu, Fengcai Zhu (), Qunying Mao () and Jingxin Li ()
Additional contact information
Siyue Jia: Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Yuanbao Liu: Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Qian He: National Institutes for Food and Drug Control
Hongxing Pan: Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Zhenglun Liang: National Institutes for Food and Drug Control
Juan Zhou: Gaoxin (Gaogang) District Center for Disease Control and Prevention
Yingzi Pan: Wujin Center for Disease Control and Prevention
Sheng Liu: Ganyu Center for Disease Control and Prevention
Jingjing Wu: Sucheng Center for Disease Control and Prevention
Kun Yang: The Affiliated Wuxi Center for Disease Control and Prevention of Nanjing Medical University
Xuanxuan Zhang: National Institutes for Food and Drug Control
Yang Zhao: Nanjing Medical University
Simin Li: Southeast University
Lei Zhang: Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Li Chen: Southeast University
Aihua Yao: Southeast University
Mengyi Lu: Nanjing Medical University
Fengcai Zhu: Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Qunying Mao: National Institutes for Food and Drug Control
Jingxin Li: Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)

Nature Communications, 2025, vol. 16, issue 1, 1-12

Abstract: Abstract 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.

Date: 2025
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DOI: 10.1038/s41467-025-58327-y

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