Trial record 4 of 27 for:    " May 22, 2007":" June 22, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborators:
Targeted Genetics Corporation
Children's Hospital of Philadelphia
Nationwide Children's Hospital
Information provided by (Responsible Party):
International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier:
NCT00482027
First received: May 31, 2007
Last updated: January 14, 2013
Last verified: May 2007
  Purpose

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 Intervention Phase
HIV Infection
Biological: tgAAC09
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by International AIDS Vaccine Initiative:

Primary Outcome Measures:
  • Safety of one or two doses of tgAAC09 [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Safety of one or two doses of tgAAC09 at 3 dosage levels in a dose-escalating an ddose-optimization study


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: up to 6 months post 2nd injection ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Biodistribution [ Time Frame: upt to 6 montsh post 1st injection ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: December 2003
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482027

Locations
Belgium
SGS Biopharma
Antwerpen, Belgium, B-2060
St. Pierre University Hospital
Brussels, Belgium, B-1000
Germany
Univeristy of Bonn
Bonn, Germany, 53127
University of Hamburg
Hamburg, Germany, 20246
India
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
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier: NCT00482027     History of Changes
Other Study ID Numbers: A001
Study First Received: May 31, 2007
Last Updated: January 14, 2013
Health Authority: India: Indian Council of Medical Research
India: Institutional Review Board
India: Ministry of Health
Belgium: Institutional Review Board
Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut

Keywords provided by International AIDS Vaccine Initiative:
HIV vaccine
Adeno-associated virus vactored vaccine
HIV-1 subtype C
Safety
Immunogenicity
Biodistribution
HIV prevention

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014