Phase I Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19
NCT04982068 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2023-04-19
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
- 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
Sponsors & Collaborators
-
Walvax Biotechnology Co., Ltd.
collaborator INDUSTRY -
Shanghai Zerun Biotechnology Co.,Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-12
- Primary Completion
- 2021-10-31
- Completion
- 2023-06-30
Countries
- China
Study Locations
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