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

Summary

To evaluate the safety and immunogenicity of COVID-19 mRNA vaccine in people aged 18 years and older, 300 participants will be enrolled and divided into two groups: low- and high-dose groups. Each dose group (150 people) will be divided into 2 age groups (75 each):18 to 59 years old and ≥ 60 years old. The subjects will be randomized into vaccine group or placebo group in a ratio of 2:1. Subjects will complete 2 doses of vaccination 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 received 0.5 ml of the study vaccine or placebo.

Timeline

Start

2022-07-06

Primary completion

2022-09-21

Completion

2022-09-21

Publications

• Jin Z, Wu J, Huang T, Zhao K, Zhang M, Liu J, Song J, Yin H, Wu X, Liu J, Zhu T, Huang H, Li J, Wang H, Gou J, Dong R. Safety, immunogenicity, persistence and dose evaluation of the CS-2034 mRNA COVID-19 vaccine: a phase II randomized controlled trial in healthy Chinese adults. BMC Infect Dis. 2025 Nov 20;25(1):1625. doi: 10.1186/s12879-025-12053-4.

Drugs

Indications