Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above

Summary

This study is a global multicenter, randomized, double-blind, placebo -controlled, adaptive designed phase Ⅲ clinical trial, in order to evaluate the efficacy, safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in adults 18 years old and above.

Timeline

Start

2020-09-15

Primary completion

2021-08-07

Completion

2022-10-21

Outcome

Met primary endpoint

paper One dose of Ad5-nCoV showed a 57·5% (95% CI 39·7-70·0, p=0·0026) efficacy against symptomatic, PCR-confirmed, COVID-19 infection at 28 days or more postvaccination PMID 34953526 ↗

Publications

• Rooyakkers A, Ye L, Cahn PE, Ruiz-Palacios GM, Ikram A, Lanas F, Navarro SRM, Sued O, Lioznov DA, Dzutseva V, Parveen G, Zubkova T, Li J, Langley JM, Wang R, Barreto L, Gou J, Zhu T, Whittle CA, Halperin SA; CanSino COVID-19 Global Efficacy Study Group. Relative efficacy, safety, and immunogenicity analysis of two doses versus one dose of recombinant coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomized, double blinded phase 3 trial. Vaccine. 2026 Apr 19;79:128424. doi: 10.1016/j.vaccine.2026.128424. Epub 2026 Mar 19.
• Ruiz-Palacios GM, Cahn PE, Halperin SA, Wang R, Wang L, Perez C, Figueroa MI, Yan M, Li R, Ye L, Huang H, Barreto L, Gou J, Zhu T. Adenovirus type 5 vector-based COVID-19 vaccine does not increase the likelihood of HIV infection. Vaccine. 2026 Apr 11;78:128378. doi: 10.1016/j.vaccine.2026.128378. Epub 2026 Mar 4.
• Halperin SA, Ye L, MacKinnon-Cameron D, Smith B, Cahn PE, Ruiz-Palacios GM, Ikram A, Lanas F, Lourdes Guerrero M, Munoz Navarro SR, Sued O, Lioznov DA, Dzutseva V, Parveen G, Zhu F, Leppan L, Langley JM, Barreto L, Gou J, Zhu T; CanSino COVID-19 Global Efficacy Study Group. Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinded, placebo-controlled phase 3 trial. Lancet. 2022 Jan 15;399(10321):237-248. doi: 10.1016/S0140-6736(21)02753-7. Epub 2021 Dec 23.

Drugs

Indications