The Safety, Tolerability and Immunogenicity of COVID-19 Vaccine (SCTV01C) in Healthy, Unvaccinated Adults

Summary

SCTV01C-02-1 is a randomized, double-blind, placebo controlled Phase Ⅰ/Ⅱ clinical trial of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant bivalent trimeric S protein vaccine manufactured by Sinocelltech, Ltd. The purpose of this study is to evaluate the safety , tolerability and immunogenicity of the experimental vaccine in healthy adults aged ≥ 18 Years previously unvaccinated.

Timeline

Start

2021-12-01

Primary completion

2023-08-04

Completion

2023-08-04

Publications

• Wang G, Zhao K, Zhao X, Cui Y, He P, Zhang T, Wang Y, Shi R, Li Y, Wang Q, Ren Y, Chen Z, Zhao X, Xie Z, Liang Y, Tian Q, Pan J, Zhang C, Han Y, Dai Y, Ni S, Zhang Y, Yang X, Fu Y, Liu D, Li J, Zhang M, Hu Z, Xie L. Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants. Expert Rev Vaccines. 2025 Dec;24(1):128-137. doi: 10.1080/14760584.2025.2456231. Epub 2025 Jan 27.
• Wang G, Zhao K, Han J, Hu Z, Zhang T, Wang Y, Shi R, Li Y, Song Q, Du H, He P, Xu S, Yang X, Fu Y, Cui Y, Xie L. Safety and immunogenicity of a bivalent SARS-CoV-2 recombinant protein vaccine, SCTV01C in unvaccinated adults: A randomized, double-blinded, placebo-controlled, phase I clinical trial. J Infect. 2023 Feb;86(2):154-225. doi: 10.1016/j.jinf.2022.11.008. Epub 2022 Nov 17. No abstract available.

Drugs

Indications