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UNKNOWNPHASE1/PHASE2

Safety and Immunogenicity of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19

A Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Immunogenicity and Safety of the Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy Adults Aged 60 Years and Above

NCT05313022•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 immunogenicity of ZR-202-CoV, administered as 2 injections (i.m) at 28 days apart in adult subjects 60 years of age and above.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Having understood the contents of the clinical study and ICF, and having signed the ICF.
•Adults of both genders, 60 years of age and older.
•Adults who can provide legal proof of identity.
•SARS-COV-2 antibody screening negative at screening visit.

Exclusion Criteria

•Having a clear or suspected allergy to the test vaccine ingredients (including S protein, aluminum hydroxide adjuvant or CpG adjuvant), or have a history of severe allergy to any previous vaccine (such as acute allergic reaction, dyspnea or angioneurotic edema, etc.) (inquiries);
•Having a history of SARS or MERS infection, or a previous infection of COVID-19 (previous nucleic acid or serum antibody test was positive) (inquiries);
•Previous vaccination with SARS-CoV-2 vaccine(including SARS-CoV-2 vaccine for clinical trial) or received other vaccines within 28 days prior to the first dose of vaccine;
•Abnormal skin (such as inflammation, induration, redness and swelling, large area scar, etc.) on both sides of the arm at the vaccination site and affecting the vaccination or safety observation(examination);
•Axillary body temperature ≥37.3℃ before the first dose vaccination(examination);
•Safety laboratory abnormal of any of the below:
•1. Liver function: ALT or ALT \> 1.25\*ULN
•2. Kidney function: serum creatinine (Cr) \> ULN
•3. Glycated hemoglobin (HbA1c) ≥ 8.0%
•Uncontrolled epilepsy or other progressive neurological diseases (inquiries);
+8 more criteria

Locations (1)

Clinical Trial Institution for Anning First Hospital

Kunming, Yunan, China

Key Dates

Start Date

January 18, 2022

Primary Completion Date

May 13, 2022

Completion Date

June 1, 2023

Last Updated

April 19, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

ZR-202-CoV

BIOLOGICAL

Placebo

OTHER

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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.

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Safety and Immunogenicity of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19

Inclusion Criteria

Exclusion Criteria

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