A Randomized, Double-blinded, Placebo-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the Recombinant SARS-CoV-2 Vaccine (CHO Cell) for the Prevention of COVID-19 in Adults Aged 18 Years and Above
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
- Enrollment
- 528
- Locations
- 1
- Primary Endpoint
- Seroconversion rate (SCR) of SARS-CoV-2 neutralising antibodies
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this double-blind, randomized, controlled study is to assess immunogenicity and safety of 202-CoV at multiple dose levels, administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age and above.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy individuals aged 18-59 years as well as 60 years and above who can provide legal identification (males and females are both required).
- •Willing to participate in the study with informed consent prior to screening
- •Negative in SARS-CoV-2 IgG and IgM test at screening.
- •Women of childbearing potential must be using effective method of birth control for 14 days prior to the enrollment of the study and must agree to continue such precautions during the study until 30 days after the second dose of the study vaccine/placebo.
- •Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 30 days after the second dose of the study vaccine/placebo.
Exclusion Criteria
- •Confirmed or asymptomatic COVID-19 cases or SARS-CoV-2 infection(had positive in SARS-CoV-2 nucleic acid test or serological test).
- •Had a history of traveling or residence in domestic area of high pandemic risk, overseas or epidemic areas, or had a history of contact with confirmed, asymptomatic or suspected COVID-19 cases within the past 14 days;
- •History of SARS;
- •Received SARS-CoV-2 vaccines for emergency use or approved SARS-CoV-2 vaccines;
- •Individuals involving a clinical study within 6 months prior to the screening visit; or planning to participate in another clinical study during study period.
- •Individual's systolic blood pressure ≥ 150mmHg and/or diastolic blood pressure ≥ 100mmHg at screening visit
- •Axillary temperature \>=37.3℃ prior to vaccination
- •Individuals in other acute diseases, or in the acute phase of chronic diseases within 3 days prior to the signing of the informed consent form.
- •Received immunoglobulin and/or blood product 3 months prior to the first vaccination.
- •Presence of uncontrolled chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic or metabolic (including diabetes mellitus) disorders, which would include the potential subject in a high-risk category for SARS-CoV-2 infection and/or its complications as judged by the investigator.
Outcomes
Primary Outcomes
Seroconversion rate (SCR) of SARS-CoV-2 neutralising antibodies
Time Frame: 56 days
Neutralizing antibody activity as detected by neutralization assay expressed as seroconversion rate at multiple time points through Day 56
Geometric mean titer (GMT) of serum IgG antibodies
Time Frame: 56 days
Serum IgG antibody levels specific for the SARS-CoV-2 S protein antigen as detected by ELISA expressed as GMTs at multiple time points through Day 56
Geometric mean fold rise (GMFR) of serum IgG antibodies
Time Frame: 56 days
GMFR of serum IgG antibodies from before vaccination to each subsequent time point
Geometric mean fold rise (GMFR) of SARS-CoV-2 neutralising antibodies
Time Frame: 56 days
GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies
Time Frame: 56 days
Neutralizing antibody activity as detected by neutralization assay expressed as GMTs at multiple time points through Day 56
Seroconversion rate (SCR) of serum IgG antibodies
Time Frame: 56 days
Serum IgG antibody levels specific for the SARS-CoV-2 S protein antigen as detected by ELISA expressed as seroconversion rate at multiple time points through Day 56
Secondary Outcomes
- Percentage of participants reporting adverse events (AEs)(From dose 1 through 28 days after the last dose)
- Percentage of participants reporting solicited AEs(For 7 days after dose 1 and dose 2)
- Percentage of participants reporting adverse events of special interest (AESIs)(From dose 1 through 12 months after the last dose)
- Percentage of participants reporting unsolicited AEs(From dose 1 through 28 days after the last dose)
- Percentage of participants reporting serious adverse events (SAEs)(From dose 1 through 12 months after the last dose)