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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

Author

Listed:
  • 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)
    Nanjing Medical University
    Southeast University)

  • 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)
    Nanjing Medical University
    Southeast University)

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.

Suggested Citation

  • 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 Ya, 2025. "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," Nature Communications, Nature, vol. 16(1), pages 1-12, December.
    • Handle: RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-58327-y
    DOI: 10.1038/s41467-025-58327-y
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