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

NCT00482027 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-01-16

No results posted yet for this study

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)

Conditions

  • HIV Infection

Interventions

BIOLOGICAL

tgAAC09

one or 2 doses of AAV-2 HIV vaccine (tgAAC09) at 3 dosage levels, dose escalation and dose optimization

Sponsors & Collaborators

  • Targeted Genetics Corporation

    collaborator INDUSTRY

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Nationwide Children's Hospital

    collaborator OTHER

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

  • Sanjay Mehendale, MD · National AIDS Research Institute

  • Nathan Clumeck, MD · St. Pierre University Hospital

  • Jan van Lunzen, MD · University of Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2006-12-31
Completion
2007-01-31

Countries

  • Belgium
  • Germany
  • India

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00482027 on ClinicalTrials.gov