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Safety of and Immune Response to an HIV-1 Subtype C Vaccine (AVX101) in HIV Uninfected Adults

NCT00097838 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2012-07-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of and immune response to an alphavirus replicon, HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults in the United States, South Africa, and Botswana.

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 S. Burke, MD · Center for Immunization Research, Johns Hopkins School of Public Health

  • Salim Abdool Karim, MD, PhD · University of KwaZulu

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
2004-10-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States
  • Botswana
  • 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 NCT00097838 on ClinicalTrials.gov