A Clinical Trial on Booster Immunization of Two COVID-19 Vaccines Constructed From Different Technical Routes

Unknown 450 enrolled Zhongnan Hospital Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

This is an open-label, randomized, parallel-controlled clinical trial conducted in people aged 18 years and older to evaluate the immunogenicity and safety of two SARS-CoV-2 bivalent vaccines constructed by adenovirus type 5-based or mRNA-based technics.

Timeline

Start: 2023-05-30
Primary completion: 2023-12-31
Completion: 2024-05-29

Outcome

Met primary endpoint

paper The Ad5-CoV5T vaccine induced a superior anti-XBB.1.5-specific neutralizing titer than Ad5-nCoV at day 28 (geometric mean titer ratio of 1.48, 95% CI 1.12-1.97) PMID 40775215 ↗

paper This trial met the main hypothesis; the findings may provide insights for the development of the next-generation COVID-19 vaccines. PMID 40775215 ↗

Publications

Wu S, Huang J, Wang B, Li J, Wu J, Zhang Z, Luo L, Zhang J, Huo N, Long J, Huang H, Chen Z, Zhang M, Zhao Z, Dan J, Song X, Mao H, Huo S, Yan H, Zhang Y, Wang X, Hou L. Safety and Immunogenicity of aerosolized adenovirus-vectored COVID-19 vaccine and intramuscular mRNA vaccine bivalent boosters: a randomized open-label clinical trial. Nat Commun. 2025 Aug 7;16(1):7281. doi: 10.1038/s41467-025-62698-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ad5-CoV5T	Vaccine	—	Inhaled
Subject	Ad5-nCoV	Vaccine	—	Inhaled
Subject	mbO5	Messenger RNA (mRNA)	—	Intramuscular