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

Shanghai Zerun Biotechnology Co.,Ltd1 site in 1 country84 target enrollmentJanuary 18, 2022

ConditionsCOVID-19

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: COVID-19
Sponsor: Shanghai Zerun Biotechnology Co.,Ltd
Enrollment: 84
Locations: 1
Primary Endpoint: Proportion of participants achieving seroconversion for SARS-CoV-2 specific IgG binding antibodies..
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 immunogenicity of ZR-202-CoV, administered as 2 injections (i.m) at 28 days apart in adult subjects 60 years of age and above.

Registry

clinicaltrials.gov

Start Date

January 18, 2022

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

•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:
•Liver function: ALT or ALT \> 1.25\*ULN
•Kidney function: serum creatinine (Cr) \> ULN
•Glycated hemoglobin (HbA1c) ≥ 8.0%
•Uncontrolled epilepsy or other progressive neurological diseases (inquiries);

Outcomes

Primary Outcomes

Proportion of participants achieving seroconversion for SARS-CoV-2 specific IgG binding antibodies..