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Safety of an HIV Vaccine (AVX101) in HIV Uninfected Volunteers in the United States and South Africa

NCT00063778 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-07-02

No results posted yet for this study

Summary

The purpose of this study is to see if different doses of an experimental HIV vaccine are safe and to study how the immune system responds to the vaccine. The vaccine will be tested in healthy, HIV uninfected volunteers. AVX101 contains only one of the many substances that HIV needs to make more copies of itself; therefore, the vaccine cannot cause HIV or AIDS.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

AVX101

Alphavirus replicon particle vaccine expressing HIV Gag antigen

OTHER

placebo

phosphate buffered saline, pH 7.2, HSA, sodium gluconate, and sucrose

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • AlphaVax, Inc.

    lead INDUSTRY

Principal Investigators

  • Donald Burke, MD · Johns Hopkins University

  • Salim Abdool Karim, MD, PhD · University of Natal, Durban, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2005-07-31
Completion
2005-07-31

Countries

  • United States
  • South Africa

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 NCT00063778 on ClinicalTrials.gov