Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249106
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2005-11-03
Brief Title:
Safety and Immunogenicity of a Plasmid HIV Vaccine in HIV Uninfected Adults
Sponsor:
International AIDS Vaccine Initiative
Organization:
International AIDS Vaccine Initiative
Study Overview
Official Title:
Randomized Placebo-Controlled Dose-Escalating Double-Blinded Phase 1 Safety and Immunogenicity Study of Clade C DNA Vaccine ADVAX eg ADVAX pN-t ADVAX Administered Intramuscularly to HIV-Uninfected Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2011-09
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:
C001
Brief Summary:
The purpose of this study is to determine the safety and immune response to a investigational DNA Plasmid HIV vaccine ADVAX eg ADVAX pn-t ADVAX at three different dosage levels in adults who are not infected with HIV
Detailed Description:
This is a dose escalation trial Study site staff and volunteers will be blinded blinding will not apply to the assignment of dose levels low middle or high
Volunteers will be screened up to 42 days before vaccination and will be followed for 18 months after the first vaccination
15 volunteers will be randomized in a 41 ratio of active vaccine to placebo Safety and tolerability of the ADVAX eg ADVAX pn-t investigational product will be evaluated at least 14 days after the tenth volunteer in the lower dosage group receives the second injection before proceeding to the nextdosage group
Volunteers will be screened up to 42 days before vaccination and will be followed for 18 months after the first vaccination
15 volunteers will be randomized in a 41 ratio of active vaccine to placebo Safety and tolerability of the ADVAX eg ADVAX pn-t investigational product will be evaluated at least 14 days after the tenth volunteer in the lower dosage group receives the second injection before proceeding to the nextdosage group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None