Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876364
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-25
First Post:
2023-05-01
Brief Title:
Study to Assess Safety Reactogenicity and Immunogenicity of the repRNAQTP104 Vaccine Against SARS-CoV-2COVID-19
Sponsor:
Quratis Inc
Organization:
Quratis Inc
Study Overview
Official Title:
A Phase 1 Dose-escalation Multi-center Open-label Study to Evaluate the Safety Reactogenicity and Immunogenicity of a Preventive SARS-CoV-2 Vaccine QTP104 in Healthy Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
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:
This study is to evaluate the safety reactogenicity and immunogenicity of the QTP104 vaccine against SARS-CoV-2 infection in healthy adults
Detailed Description:
This study is designed to evaluate the safety immunogenicity of 3 doses of QTP104 The reason for including 3 doses were to further explore the immunogenicity of these dose levels This clinical trial is an open label and does not apply to randomized assignment procedures This study is an open label and does not apply to the maintenance and release procedure of double-blinding The selection of healthy adults is to confirm the safety of dose-escalation through phase 1 clinical trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None