NCT05373485

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

A Randomized, Double-blind, Dose-exploring, Placebo-controlled, Multi-center Phase I Clinical Trial Evaluating the Safety and Immunogenicity of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 mRNA vaccine	2 doses of vaccine on Day 0 and Day 21
BIOLOGICAL	Placebo	2 doses of placebo on Day 0 and Day 21

Timeline

• Start date: 2022-05-17
• Primary completion: 2022-08-08
• Completion: 2022-08-08
• First posted: 2022-05-13
• Last updated: 2024-12-04

Locations

3 sites across 1 country: China