drugset / Trial / NCT04341389
A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector)
Phase 2
Completed
508 enrolled
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
CanSino Biologics Inc. · collabHubei Provincial Center for Disease Control and Prevention · collabJiangsu Province Centers for Disease Control and Prevention · collabZhongnan Hospital · collab
RandomizedCrossoverDouble-blindPrevention
Summary
This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.
Timeline
- Start
- 2020-04-12
- Primary completion
- 2020-11-30
- Completion
- 2020-12-31
Publications
- Feng JL, Wang WJ, Jin PF, Zheng H, Jin LR, Xia X, Zhang XY, Li ZP, Li JX, Zhu FC. Comparison of antibody persistency through one year between one-dose and two-dose regimens of Ad5-nCoV vaccine for COVID-19. Hum Vaccin Immunother. 2023 Aug 1;19(2):2230760. doi: 10.1080/21645515.2023.2230760.
- Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, Li JX, Yang BF, Wang L, Wang WJ, Wu SP, Wang Z, Wu XH, Xu JJ, Zhang Z, Jia SY, Wang BS, Hu Y, Liu JJ, Zhang J, Qian XA, Li Q, Pan HX, Jiang HD, Deng P, Gou JB, Wang XW, Wang XH, Chen W. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020 Aug 15;396(10249):479-488. doi: 10.1016/S0140-6736(20)31605-6. Epub 2020 Jul 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ad5-nCoV | Vaccine | 5e+10 unknown | Intramuscular |
| Comparator | Ad5-nCoV | Vaccine | 1e+11 unknown | Intramuscular |