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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.
ClinicalTrials.gov Identifier: NCT00482027
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : January 16, 2013
Sponsor:
Collaborators:
Targeted Genetics Corporation
Children's Hospital of Philadelphia
Nationwide Children's Hospital
Information provided by (Responsible Party):
International AIDS Vaccine Initiative

May 31, 2007
June 4, 2007
January 16, 2013
December 2003
December 2006   (Final data collection date for primary outcome measure)
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
  • Safety [ Time Frame: One year ]
  • Immunogenicity [ Time Frame: one year ]
Complete list of historical versions of study NCT00482027 on ClinicalTrials.gov Archive Site
Immunogenicity [ Time Frame: up to 6 months post 2nd injection ]
Biodistribution [ Time Frame: 6 months ]
Biodistribution [ Time Frame: upt to 6 montsh post 1st injection ]
Not Provided
 
Safety and Immunogenicity Study of tgAAC09, a Gag-PR-RT AAV HIV Vaccine
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
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)
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infection
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
  • Active Comparator: 1 AAV-2 HIV Vaccine
    64 volunteers receiving AAV-2 HIV vaccine tgAAC09 at 3 dosage levels, dose escalation and dose optimization
    Intervention: Biological: tgAAC09
  • Placebo Comparator: 2
    16 volunteers receiving formulation buffer consisting of a buffered salt solution with potassium phosphate, calcium chloride, magnesium chloride, and HEPES

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
Same as current
January 2007
December 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   India
 
 
NCT00482027
A001
Yes
Not Provided
Not Provided
International AIDS Vaccine Initiative
International AIDS Vaccine Initiative
  • Targeted Genetics Corporation
  • Children's Hospital of Philadelphia
  • Nationwide Children's Hospital
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
International AIDS Vaccine Initiative
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP