A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines

Summary

The study is a randomized, double-blind, and positive-controlled Phase III booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with either one dose of Sinopharm inactivated COVID-19 vaccine (Cohort 1) or one dose of Comirnaty (Cohort 2).

Timeline

Start

2022-05-30

Primary completion

2022-10-28

Completion

2023-05-01

Publications

• Hannawi S, Yan L, Saifeldin L, Abuquta A, Alamadi A, Mahmoud SA, Hassan A, Zhang M, Gao C, Chen Y, Gai W, Xie L. Safety and immunogenicity of multivalent SARS-CoV-2 protein vaccines: a randomized phase 3 trial. EClinicalMedicine. 2023 Sep 8;64:102195. doi: 10.1016/j.eclinm.2023.102195. eCollection 2023 Oct.
• Wang R, Huang H, Yu C, Sun C, Ma J, Kong D, Lin Y, Zhao D, Zhou S, Lu J, Cao S, Zhang Y, Luo C, Li X, Wang Y, Xie L. A spike-trimer protein-based tetravalent COVID-19 vaccine elicits enhanced breadth of neutralization against SARS-CoV-2 Omicron subvariants and other variants. Sci China Life Sci. 2023 Aug;66(8):1818-1830. doi: 10.1007/s11427-022-2207-7. Epub 2022 Dec 30.

Drugs

Indications