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

January 14, 2013 updated by: International AIDS Vaccine Initiative

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, B-2060
        • SGS Biopharma
      • Brussels, Belgium, B-1000
        • St. Pierre University Hospital
  • Germany
      • Bonn, Germany, 53127
        • Univeristy of Bonn
      • Hamburg, Germany, 20246
        • University of Hamburg
  • India
      • Pune, India, 411 026
        • National AIDS Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity
Time Frame: up to 6 months post 2nd injection
up to 6 months post 2nd injection

Other Outcome Measures

Outcome Measure
Time Frame
Biodistribution
Time Frame: upt to 6 montsh post 1st injection
upt to 6 montsh post 1st injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International AIDS Vaccine Initiative

Collaborators

Children's Hospital of Philadelphia
Nationwide Children's Hospital
Targeted Genetics Corporation

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-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

May 31, 2007

First Submitted That Met QC Criteria

June 1, 2007

First Posted (Estimate)

June 4, 2007

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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