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Safety and Immunogenicity Study of tgAAC09, a Gag-PR-RT AAV HIV Vaccine (A001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00482027
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : January 16, 2013
Targeted Genetics Corporation
Children's Hospital of Philadelphia
Nationwide Children's Hospital
Information provided by (Responsible Party):
International AIDS Vaccine Initiative

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)

Condition or disease Intervention/treatment Phase
HIV Infection Biological: tgAAC09 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : December 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: 1 AAV-2 HIV Vaccine
64 volunteers receiving AAV-2 HIV vaccine tgAAC09 at 3 dosage levels, dose escalation and dose optimization
Biological: tgAAC09
one or 2 doses of AAV-2 HIV vaccine (tgAAC09) at 3 dosage levels, dose escalation and dose optimization
Other Name: AAV-2 HIV Vaccine

Placebo Comparator: 2
16 volunteers receiving formulation buffer consisting of a buffered salt solution with potassium phosphate, calcium chloride, magnesium chloride, and HEPES

Primary Outcome Measures :
  1. Safety of one or two doses of tgAAC09 [ Time Frame: One year ]
    Safety of one or two doses of tgAAC09 at 3 dosage levels in a dose-escalating an ddose-optimization study

Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: up to 6 months post 2nd injection ]

Other Outcome Measures:
  1. Biodistribution [ Time Frame: upt to 6 montsh post 1st injection ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy males and females
  • Age at least 18 years on the day of screening and no greater than 50 years on the day of vaccination
  • Available for follow-up for the planned duration of the study (screening plus 12 months)
  • Able to give written informed consent;
  • No reported high-risk behavior for HIV (Appendix C), willing to undergo HIV testing and receive results;
  • If sexually active, willing to use or have partner use condoms from screening until at least 4 months after the vaccination. Additional means of contraception are permitted and encouraged.

Exclusion Criteria:

  • Clinically relevant abnormality on history or examination including history of immunodeficiency or use of immunosuppressive medication in last 6 months;
  • A chronic medical condition or concurrent condition, which, in the opinion of the investigator, would make the volunteer unsuitable for the study.
  • Any of the following abnormal laboratory parameters that are mild and judged to be clinically significant by the principal investigator or designee, or moderate, severe, or very severe: hematology (hemoglobin, absolute neutrophil count [ANC] absolute lymphocyte count [ALC], absolute CD4 count, platelets); urinalysis, clinical chemistry (total bilirubin, creatinine, AST, ALT). Refer to Appendix D for the grading of these laboratory parameters.
  • If female, pregnant or planning a pregnancy within 4 months after receiving the vaccine, or lactating;
  • Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of vaccination;
  • Receipt of other experimental HIV vaccine at any time;
  • Receipt of blood transfusion or blood products within 6 months of vaccination;
  • Participation in another clinical trial of an investigational product currently or within 12 weeks of vaccination, or expected during participation in this study;
  • History of severe local or systemic reaction to vaccination or history of allergic reactions to vaccines;
  • Confirmed infection with HIV-1 or HIV-2;
  • Positive for hepatitis B (surface antigen), hepatitis C antibodies, or active syphilis (confirmed by treponemal test such as TPHA in addition to non-treponemal test such as RPR) or active tuberculosis.
  • Unlikely to comply with protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00482027

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SGS Biopharma
Antwerpen, Belgium, B-2060
St. Pierre University Hospital
Brussels, Belgium, B-1000
Univeristy of Bonn
Bonn, Germany, 53127
University of Hamburg
Hamburg, Germany, 20246
National AIDS Research Institute
Pune, India, 411 026
Sponsors and Collaborators
International AIDS Vaccine Initiative
Targeted Genetics Corporation
Children's Hospital of Philadelphia
Nationwide Children's Hospital
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Principal Investigator: Sanjay Mehendale, MD National AIDS Research Institute
Principal Investigator: Nathan Clumeck, MD St. Pierre University Hospital
Principal Investigator: Jan van Lunzen, MD University of Hamburg

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: International AIDS Vaccine Initiative Identifier: NCT00482027    
Other Study ID Numbers: A001
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: May 2007
Keywords provided by International AIDS Vaccine Initiative:
HIV vaccine
Adeno-associated virus vactored vaccine
HIV-1 subtype C
HIV prevention
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs