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Phase I Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19 | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Phase I Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19

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

NCT04982068•Shanghai Zerun Biotechnology Co.,Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+8 more criteria

Locations (1)

Xiangcheng Center for Disease Control and Prevention

Xuchang, China

Key Dates

Start Date

July 12, 2021

Primary Completion Date

October 31, 2021

Completion Date

June 1, 2023

Last Updated

April 19, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

202-CoV low adjuvant dose

BIOLOGICAL

202-CoV low antigen dose

BIOLOGICAL

202-CoV standard dose

BIOLOGICAL

Placebo

OTHER

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Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase I Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19

Inclusion Criteria

Exclusion Criteria

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