NCT04659239

The Efficacy, Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19

A Randomized, Double-Blinded, Placebo Controlled Phase III Clinical Trial of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in Adults Aged 18 Years and Above

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34,020 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blinded, placebo controlled phase III clinical trial to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above after 2-dose schedule.

Detailed description

The trial includes two parts, namely the efficacy study and immunogenicity bridging study. A total of 34020 participants will be enrolled, i.e. 32820 for efficacy cohort, and 1200 for domestic immunogenicity cohort in China. Efficacy study: Participants will be randomly inoculated with two doses of investigational vaccine or placebo according to 1:1 ratio following Day 0-Day 14 immunization schedule and will be observed from the first dose of investigational vaccine to collect symptomatic and laboratory-confirmed COVID-19 cases for the evaluation of the efficacy of the investigational vaccine. Immunogenicity bridging study: Before inoculating the first dose, 14 days, 6 months and 12 months after the whole-course immunization, blood samples will be taken for determination of neutralizing antibody and IgG antibody against SARS-CoV-2 (ELISA method); and before inoculating the first dose, 6 months and 12 months after the whole-course immunization, blood samples will be taken for detecting specific T cells with the ELISPOT assay with an aim to evaluate immunogenicity and immune persistence. Safety observations for all participants will be conducted from the first dose to 28 days after the whole-course immunization, and follow-up of SAEs will also be conducted from the first dose to at least 12 months after the whole-course immunization to evaluate the safety of the investigational vaccine.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated SARS-CoV-2 Vaccine (Vero cell)	The inactivated SARS-CoV-2 vaccine (vero cell) was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.
BIOLOGICAL	Placebo	The placebo was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.

Timeline

• Start date: 2021-01-28
• Primary completion: 2021-09-01
• Completion: 2022-07-01
• First posted: 2020-12-09
• Last updated: 2021-02-10

Locations

2 sites across 2 countries: Brazil, Malaysia