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Safety and Immunogenicity Study of tgAAC09, an HIV Vaccine in an Adeno-associated Virus (AAV) Capsid

NCT00888446 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2012-12-17

No results posted yet for this study

Summary

This phase 2 study will evaluate the safety, immunogenicity and optimal timing of two injections at three dose levels of the tgAAC09 vaccine in healthy volunteers. Study volunteers will receive two intramuscular injections of tgAAC09 or placebo at Months 0 and 6 (groups A, C, E and G) or at Months 0 and 12 (groups B, D and F) and be followed for a total of 18 months following the first injection with the exception of group G in which volunteers will be followed for 12 months after the first injection (6 months after the second injection). This study will explore whether boosting is possible, and compare a shorter and more practical six-month time interval with a twelve-month time interval.

Conditions

  • Human Immunodeficiency Virus Infections
  • HIV Infections

Interventions

BIOLOGICAL

tgAAC09

BIOLOGICAL

tgAAC09

BIOLOGICAL

tgAAC09

OTHER

Formulation buffer

Sterile isotonic buffered salt solution

Sponsors & Collaborators

  • Targeted Genetics Corporation

    collaborator INDUSTRY

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

  • Eftyhia Vardas, MD · Perinatal HIV Research Unit (PHRU), Baragwanath

  • Linda-Gail Bekker, MD · Desmond Tutu HIV Centre Cape Town

  • Anwar Hoosen · Medical University of Southern Africa (Medunsa)

  • Elwyn Chomba, MD · Zambia-Emory HIV Research Project (ZEHRP), Lusaka

  • Pontiano Kaleebu, MD, PhD · MRC/UVRI and LSHTM Uganda Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • South Africa
  • Uganda
  • Zambia

Study Locations

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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 NCT00888446 on ClinicalTrials.gov