Phase I Clinical Trial of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older

Summary

To evaluate the safety and immunogenicity of the COVID-19 mRNA vaccine in people aged 18 years and older, 80 participants will be enrolled and divided into two groups: low- and high-dose groups. Each dose group will be divided into 2 age groups (20 people each):18 to 59 years old and ≥ 60 years old. Subjects will be randomized into vaccine group or placebo group in a ratio of 3:1. Subjects will receive 2 doses of either vaccine or placebo on Day 0 and Day 21, in which the low-dose group will received 0.3 ml of the study vaccine or placebo, and the high dose group will receive 0.5 ml of the study vaccine or placebo.

Timeline

Start

2022-05-17

Primary completion

2022-08-08

Completion

2022-08-08

Publications

• Jin Z, Wu J, Wang Y, Huang T, Zhao K, Liu J, Wang H, Zhu T, Gou J, Huang H, Wu X, Yin H, Song J, Li R, Zhang J, Li L, Chen J, Li X, Zhang M, Li J, Hou M, Song Y, Wang B, Gao Q, Wu L, Kong Y, Dong R. Safety and immunogenicity of the COVID-19 mRNA vaccine CS-2034: A randomized, double-blind, dose-exploration, placebo-controlled multicenter Phase I clinical trial in healthy Chinese adults. J Infect. 2023 Dec;87(6):556-570. doi: 10.1016/j.jinf.2023.10.012. Epub 2023 Oct 28.

Drugs

Indications