drugset / Trial / NCT04840992
Phase I/II Clinical Trial of Recombinant Novel Coronavirus (COVID-19) Vaccine (Adenovirus Type 5 Vector) for Inhalation
Phase 1/2
Completed
840 enrolled
CanSino Biologics Inc.
Beijing Institute of Biotechnology · collabJiangsu Province Centers for Disease Control and Prevention · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study is a randomized, double-blind, placebo-controlled I/II clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation in adults 18 years of Age and Older.
Timeline
- Start
- 2021-04-21
- Primary completion
- 2022-07-08
- Completion
- 2022-08-09
Publications
- Zhu Y, Tang R, Li X, Chen X, Wang X, Wang Y, Wang R, Zhu F, Li J. Vaccination with Adenovirus Type 5 Vector-Based COVID-19 Vaccine as the Primary Series in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Clinical Trial. Vaccines (Basel). 2024 Mar 11;12(3):292. doi: 10.3390/vaccines12030292.
- Xia X, Tan ZM, Wan P, Zheng H, Tang R, Chen XQ, Guo XL, Zhu T, Feng JL, Zhong J, Li XL, Zhang ZY, Zhu FC, Li JX. Environmental Impact Assessment for the Use of an Orally Aerosolized Adenovirus Type-5 Vector-Based COVID-19 Vaccine in Randomized Clinical Trials. J Infect Dis. 2023 Sep 15;228(6):715-722. doi: 10.1093/infdis/jiad134.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ad5-nCoV | Vaccine | 5e+09 unknown | Inhaled |
| Subject | Ad5-nCoV | Vaccine | 1e+10 unknown | Inhaled |
| Subject | Ad5-nCoV | Vaccine | 2e+10 unknown | Inhaled |
| Subject | Ad5-nCoV | Vaccine | 5e+10 unknown | Inhaled |