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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
34,020
The inactivated SARS-CoV-2 vaccine (vero cell) was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.
The placebo was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.
CEMEC Pesquisa Clinica
São Bernardo do Campo, São Paulo, Brazil
Hospital Sungai Buloh
Sungai Buloh, Selangor, Malaysia
The incidence of COVID-19 cases after two-doses of vaccination
The incidence of the symptomatic and laboratory-confirmed COVID-19 cases starting from Day 14 after the second dose.
Time frame: From 14 days after the second dose to 1 year after the second dose.
The incidence of solicited AEs.
The incidence of solicited AEs at the inoculation site (local) and solicited AEs at the non-inoculation site (systemic) within 7 days after each dose
Time frame: 7 days after each dose
The incidence of COVID-19 cases after at least one dose of immunization.
The incidence of the symptomatic and laboratory-confirmed COVID-19 cases after at least one dose of immunization.
Time frame: From the first dose to 1 year after the second dose.
The Geometric Mean Titer (GMT) of neutralizing antibody
The Geometric Mean Titer (GMT) of neutralizing antibody against SARS-CoV-2 14 days after the whole-course immunization.
Time frame: 14 days after the whole-course immunization
The Geometric Mean Titer (GMT) of IgG antibody
The Geometric Mean Titer (GMT) of IgG antibody (ELISA method) against SARS-CoV-2 14 days after the whole-course immunization.
Time frame: 14 days after the whole-course immunization
The positive rates of neutralizing antibody
The positive rates of neutralizing antibody against SARS-CoV-2 14 days after the whole-course immunization.
Time frame: 14 days after the whole-course immunization
The positive rates of IgG antibody
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The positive rates of IgG antibody (ELISA method) against SARS-CoV-2 14 days after the whole-course immunization.
Time frame: 14 days after the whole-course immunization
The seroconversion rates of neutralizing antibody
The seroconversion rates of neutralizing antibody against SARS-CoV-2 14 days after the whole-course immunization.
Time frame: 14 days after the whole-course immunization
The seroconversion rates of IgG antibody
The seroconversion rates of IgG antibody (ELISA method) against SARS-CoV-2 14 days after the whole-course immunization.
Time frame: 14 days after the whole-course immunization
The positive rates of neutralizing antibody
The positive rates of neutralizing antibody against SARS-CoV-2 6 months and 12 months after whole-course immunization.
Time frame: 6 months and 12 months after whole-course immunization.
The positive rates of IgG antibody
The positive rates of IgG antibody (ELISA method) against SARS-CoV-2 6 months and 12 months after whole-course immunization.
Time frame: 6 months and 12 months after whole-course immunization.
The Geometric Mean Titer (GMT) of neutralizing antibody
The Geometric Mean Titer (GMT) of neutralizing antibody against SARS-CoV-2 6 months and 12 months after whole-course immunization.
Time frame: 6 months and 12 months after whole-course immunization.
The Geometric Mean Titer (GMT) of IgG antibody
The Geometric Mean Titer (GMT) of IgG antibody (ELISA method) against SARS-CoV-2 6 months and 12 months after whole-course immunization.
Time frame: 6 months and 12 months after whole-course immunization.
Specific T cells with ELISPOT assay
Detecting specific T cells with ELISPOT assay 6 months and 12 months after the whole-course immunization
Time frame: 6 months and 12 months after the whole-course immunization
The incidence of AEs
The incidence of AEs from the first dose to 28 days after whole-course immunization
Time frame: From the first dose to 28 days after whole-course immunization.
The incidence of SAEs
The incidence of SAEs from the first dose to at least 12 months after whole-course immunization.
Time frame: From the first dose to at least 12 months after whole-course immunization.
The occurrence of Antibody Dependent Enhancement (ADE)/ Vaccine Enhanced Disease(VED)
The occurrence of Antibody Dependent Enhancement (ADE)/ Vaccine Enhanced Disease(VED) that probably related to the laboratory-confirmed COVID-19 from 14 days after the second dose till the end of trial.
Time frame: From 14 days after the second dose to 1 year after the second dose.