Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655625
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2020-11-26
Brief Title:
Phase II III Study of COVID-19 DNA Vaccine AG0302-COVID19
Sponsor:
AnGes Inc
Organization:
AnGes Inc
Study Overview
Official Title:
A Randomized Double-blind Placebo Controlled Phase II III Study to Assess Safety Immunogenicity and Efficacy of Twice Dosing of Intramuscular AG0302-COVID19 2mg in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2022-06
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 will assess the safety immunogenicity and efficacy of AG0302-COVID19 in healthy adult volunteers
Detailed Description:
This is a Phase II III multi-center randomized double-blind placebo controlled trial Approximately 500 healthy volunteers male or female aged 18 years or older will be randomized to one of the following two groups
Group A Vaccination twice at 2-week intervals n 250 Group B Vaccination twice at 4-week intervals n 250
Fifty subjects in each group will receive placebos
Group A Vaccination twice at 2-week intervals n 250 Group B Vaccination twice at 4-week intervals n 250
Fifty subjects in each group will receive placebos
Study Oversight
Has Oversight DMC:
None
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?:
None