A Randomized, Double-blinded, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Immunogenicity of the Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy Adults Aged 18 Years and Above

Shanghai Zerun Biotechnology Co.,Ltd1 site in 1 country72 target enrollmentJuly 12, 2021

ConditionsCOVID-19

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: COVID-19
Sponsor: Shanghai Zerun Biotechnology Co.,Ltd
Enrollment: 72
Locations: 1
Primary Endpoint: Incidence of solicited adverse events (AEs) after vaccination
Status: Active, Not Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and preliminary immunogenicity 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.

Registry

clinicaltrials.gov

Start Date

July 12, 2021

End Date

June 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Zerun Biotechnology Co.,Ltd

Responsible Party

Sponsor

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 vaccine/placebo 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 and moderate 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.
•Clinical laboratory abnormalities and with clinical significance judged by investigator
•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.

Outcomes

Primary Outcomes

Incidence of solicited adverse events (AEs) after vaccination

Time Frame: 7 days after the first or second vaccination

Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 28) by intensity, relevance.

Incidence of unsolicited AEs after vaccination

Time Frame: Frame: Day 0 to Day 56

Percentage of participants with unsolicited AEs for 28 days following each vaccination

Secondary Outcomes

Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis and coagulation parameters(Day 4 after first or second vaccination)
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies(Day0, Day28, Day42 and Day56)
Seroconversion rate (SCR) of SARS-CoV-2 neutralising antibodies(Day0, Day28, Day42 and Day56)
Geometric mean titer (GMT) of Serum IgG Antibody Levels(Day0, Day28, Day42 and Day56)
Seroconversion rate (SCR) of Serum IgG Antibody Levels(Day0, Day28, Day42 and Day56)
Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)(Day 0 to Month 13)