An Investigator Initiated, Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Immunogenicity and Efficacy of the Recombinant Two-component COVID-19 Vaccine (CHO Cell) in Adults Aged 18 Years and Older

Summary

Study Objective(s) To evaluate the safety, immunogenicity and protective efficacy of 1 dose of ReCOV in participants who have received 2 or 3 doses of inactivated SARS-CoV-2 vaccination in Chinese adults aged 18 years and older. Primary objective To demonstrate the safety within 30 days after booster dose. Secondary objective(s) To evaluate the immunogenicity after booster dose. To demonstrate the safety within 6 months after booster dose. To evaluate the protective efficacy of RT-PCR-confirmed SARS-CoV-2 infection and COVID-19 after booster dose. Indications：Prevention of COVID-19 caused by SARS-CoV-2 Population：Participants aged 18 years and older who completed 2 or 3 doses vaccination of inactivated COVID-19 vaccines and whose last dose was given 6-18 months, of which the elderly aged 60 years and older account for about 10% to 15%. Sample Size：Approximately 3,300 participants

Timeline

Start

2022-12-27

Primary completion

2023-06-30

Completion

2023-12-31

Drugs

Indications