Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-30 @ 11:36 PM
Study NCT ID:
NCT04982068
Status:
UNKNOWN
Last Update Posted:
2023-04-19
First Post:
2021-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19
Sponsor:
Shanghai Zerun Biotechnology Co.,Ltd
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: