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
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.
Authors
- Ming‐Kuei Lu (ORCID: https://orcid.org/0000-0002-2768-4399)
- Hongxing Pan (ORCID: https://orcid.org/0000-0002-3791-1241)
- Jingxin Li (ORCID: https://orcid.org/0000-0002-7033-5151)
- Siyue Jia (ORCID: https://orcid.org/0000-0002-0648-4507)
- Aihua Yao (ORCID: https://orcid.org/0000-0003-3144-6243)
- Kun Yang (ORCID: https://orcid.org/0000-0002-8891-5736)
- Fengcai Zhu (ORCID: https://orcid.org/0000-0002-1644-0006)
- Qunying Mao (ORCID: https://orcid.org/0000-0002-8967-4436)
- Yuanbao Liu (ORCID: https://orcid.org/0000-0002-5703-6931)
- Sheng Hong Liu (ORCID: https://orcid.org/0000-0001-5933-1101)
- Li Chen (ORCID: https://orcid.org/0000-0001-8492-1963)
- Juan Zhou (ORCID: https://orcid.org/0000-0001-5803-0948)
- Jingjing Wu (ORCID: https://orcid.org/0000-0002-6396-817X)
- Simin Li (ORCID: https://orcid.org/0000-0002-0400-2180)
- Zhenglun Liang (ORCID: https://orcid.org/0000-0002-6740-0864)
- Qian He (ORCID: https://orcid.org/0000-0001-7824-2526)
- Lei Zhang (ORCID: https://orcid.org/0009-0009-1254-6282)
- Yingzi Pan
- Xuanxuan Zhang
- Yang Zhao (ORCID: https://orcid.org/0000-0003-2542-4734)
Institutions
- Xian Center for Disease Control and Prevention (CN)
- Southeast University (BD)
- Jiangsu Provincial Center for Disease Control and Prevention (CN)
- Nanjing Municipal Center for Disease Control And Prevention (CN)
- National Institutes for Food and Drug Control (CN)
- Wuxi People's Hospital (CN)
- Southeast University (CN)
- Nanjing Medical University (CN)
Publication Details
- Journal
- Nature Communications
- Published
- 2025-03-26
- DOI
- https://doi.org/10.1038/s41467-025-58327-y
- Citations
- 3
- Primary Topic
- SARS-CoV-2 and COVID-19 Research
- Type
- article
- Field-Weighted Citation Impact
- 4.19