Safety and Immunogenicity Study of tgAAC09, a Gag-PR-RT AAV HIV Vaccine (A001)
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
Sponsor: Children's Hospital of Philadelphia
Listed as NCT00482027, this PHASE1 trial focuses on HIV Infection and remains completed. Sponsored by Children's Hospital of Philadelphia, it has been updated 6 times since 2003, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE1
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE1
First recorded
Dec 2003
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Children's Hospital of Philadelphia
- International AIDS Vaccine Initiative
- Nationwide Children's Hospital
- Targeted Genetics Corporation
For direct contact, visit the study record on ClinicalTrials.gov .