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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
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.
Details
| Lead sponsor | Shanghai Zerun Biotechnology Co.,Ltd |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 84 |
| Start date | 2022-01-18 |
| Completion | 2023-06 |
Conditions
- COVID-19
Interventions
- ZR-202-CoV
- Placebo
Primary outcomes
- Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody — 28 days after each dose
- Proportion of participants achieving seroconversion for SARS-CoV-2 neutralising antibody — 28 days after each dose
- Geometric mean increase (GMI) of SARS-CoV-2 neutralising antibodies — 28 days after each dose
- Geometric mean titer (GMT) of SARS-CoV-2 specific IgG binding antibodies. — 28 days after each dose
- Proportion of participants achieving seroconversion for SARS-CoV-2 specific IgG binding antibodies.. — 28 days after each dose
- Geometric mean increase (GMI) of SARS-CoV-2 specific IgG binding antibodies. — 28 days after each dose
Countries
China