Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482027
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2007-05-31
Brief Title:
Safety and Immunogenicity Study of tgAAC09 a Gag-PR-RT AAV HIV Vaccine
Sponsor:
International AIDS Vaccine Initiative
Organization:
International AIDS Vaccine Initiative
Study Overview
Official Title:
A Phase 1 Randomized Placebo-controlled Double-blind Dose-escalation Trial to Evaluate the Safety and Immunogenicity of tgAAC09 a Gag-PR-RT AAV HIV Vaccine
Status:
COMPLETED
Status Verified Date:
2007-05
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:
A001
Brief Summary:
The purpose of this study is to determine safety and immunogenicity ability to induce an immune response of a novel HIV vaccine based on adeno-associated virus AAV
Detailed Description:
The need for a vaccine to prevent AIDS and interrupt transmission of HIV is indisputable To be effective an HIV vaccine will have to induce cellular and humoral immune responses that are durable and potent Intra-muscular delivery of HIV genes enclosed within recombinant adeno-associated virus rAAV protein capsid has been shown to be a potent inducer of both antibodies and T-cell responses in animal studies tgAAC09 consisting of single-stranded DNA from Clade C HIV-1 genes for the gag protease and part of the reverse transcriptase proteins enclosed within a rAAV serotype 2 protein capsid was developed as one component of a multi-component HIV vaccine The purpose of this study is to evaluate the safety and immunogenicity of tgAAC09 in healthy HIV-seronegative volunteers
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