Trials / Unknown
UnknownNCT04982068
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Shanghai Zerun Biotechnology Co.,Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 202-CoV low adjuvant dose | standard dose of 202-CoV with low dose CpG / alum adjuvant |
| BIOLOGICAL | 202-CoV low antigen dose | low dose 202-CoV with CpG / alum adjuvant |
| BIOLOGICAL | 202-CoV standard dose | standard dose 202-CoV with CpG / alum adjuvant |
| OTHER | Placebo | Normal saline solution |
Timeline
- Start date
- 2021-07-12
- Primary completion
- 2021-10-31
- Completion
- 2023-06-01
- First posted
- 2021-07-29
- Last updated
- 2023-04-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04982068. Inclusion in this directory is not an endorsement.