Trials / Unknown
UnknownNCT05490108
Evaluation of Safety and Immunogenicity of the Recombinant ZR202-CoV and ZR202a-CoV Vaccines in Adults.
A Two-part, Phase I/II, Randomized, Observer-blinded, Controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Recombinant ZR202-CoV and ZR202a-CoV Vaccines Administered at 0 and 28 Days as Compared to Comirnaty ®, and of a Booster Dose of ZR202a-CoV Vaccine in Healthy Adults.
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Shanghai Zerun Biotechnology Co.,Ltd · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
For Phase 1 only. Additional information will be provided when Phase 2 is implemented. This is a two-part phase I/II, single-center, observer-blind, randomized, controlled vaccine trial to evaluate the safety, reactogenicity, and immunogenicity of the recombinant ZR202-CoV and ZR202a-CoV vaccines administered at 0 and 28 days as compared to Comirnaty®, and of a booster dose of ZR202a-CoV vaccine in healthy adults. Part 1: A total of 60 eligible subjects will be randomized in a 1:1:1 ratio into one of the three vaccine groups (ZR202-CoV, ZR202a-CoV, or Comirnaty®), receiving 2 doses vaccination at 28 days interval. To assess safety and preliminary immunogenicity profile after primary series vaccination at pre-defined time points during the study. The DSMB will review the safety data and provide a recommendation to the Sponsor on whether the safety profile is acceptable for advancing to Part 2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ZR202-CoV | SARS-CoV-2 adjuvanted recombinant protein vaccine (prototype) |
| BIOLOGICAL | ZR202a-CoV | SARS-CoV-2 adjuvanted recombinant protein vaccine (variant) |
| BIOLOGICAL | Comirnaty® | Comirnaty® (Pfizer-BioNTech) |
Timeline
- Start date
- 2022-06-02
- Primary completion
- 2022-09-26
- Completion
- 2023-08-01
- First posted
- 2022-08-05
- Last updated
- 2023-04-20
Locations
1 site across 1 country: Mali
Source: ClinicalTrials.gov record NCT05490108. Inclusion in this directory is not an endorsement.