Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-27 @ 10:03 PM
Study NCT ID:
NCT04885361
Status:
UNKNOWN
Last Update Posted:
2021-06-09
First Post:
2021-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety, and Immunogenicity of Vaccine Candidate Against COVID-19, in Healthy Adults
Sponsor:
OSE Immunotherapeutics
Organization:
Study Overview
Official Title:
A Randomized, Open Label, Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of OSE-13E, a Multiepitope-based Vaccine Candidate Against COVID-19, in Healthy Adults (COVEPIT-3)
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
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:
COVEPIT 3
Brief Summary:
The proposed study is a phase 1 study which will evaluate the safety, reactogenicity and immunogenicity of two doses regimen of CoVepiT vaccine (OSE-13E) in the population of n=48 healthy volunteers 18 to 45 (inclusive) years old, vaccinated or not by authorized COVID-19 vaccine.
Study will be open label and will be randomized 1:1 in two parallel study arms receiving either one single dose or two doses separated by 21 days.
First 4 subjects will serve as sentinel cohort and 7 days reactogenicity data of these subjects will be reviewed by the independent safety monitoring committee (SMC) before proceeding to the vaccination of remaining volunteers. The progress of the study will be overviewed by a safety monitoring committee (SMC).
The CoVepiT vaccine is a peptide-based vaccine aiming to induce CD8+T-cell-mediated immune response against 11 different proteins of SARS-CoV-2 virus.
Study will be open label and will be randomized 1:1 in two parallel study arms receiving either one single dose or two doses separated by 21 days.
First 4 subjects will serve as sentinel cohort and 7 days reactogenicity data of these subjects will be reviewed by the independent safety monitoring committee (SMC) before proceeding to the vaccination of remaining volunteers. The progress of the study will be overviewed by a safety monitoring committee (SMC).
The CoVepiT vaccine is a peptide-based vaccine aiming to induce CD8+T-cell-mediated immune response against 11 different proteins of SARS-CoV-2 virus.
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?: