Safety of and Immune Response to an HIV-1 Subtype C Vaccine (AVX101) in HIV Uninfected Adults
Completed · Phase 1 · Has a placebo group
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00097838
- Run by
- AlphaVax, Inc.
- People needed
- 96
- Starts
- 2004-10-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2012-07-02
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- HIV uninfected
- At low risk for HIV infection
- Willing to receive HIV test results
- Good general health
- Acceptable methods of contraception for females of reproductive potential
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive
- Meets educational requirements of the study
You may not qualify if…
- HIV vaccines or placebos in prior HIV vaccine trial
- Immunosuppressive medications within 168 days prior to first study vaccine administration
- Blood products within 120 days prior to first study vaccine administration
- Immunoglobulin within 60 days prior to first study vaccine administration
- Live attenuated vaccines within 30 days prior to first study vaccine administration
- Investigational research agents within 30 days prior to first study vaccine administration
- Subunit or killed vaccines within 14 days prior to first study vaccine administration
- Allergy treatment with antigen injections within 30 days prior to first vaccine administration
- Current tuberculosis prophylaxis or therapy
- Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
- Autoimmune disease or immunodeficiency
- Active syphilis
- Unstable asthma
- Type 1 or type 2 diabetes mellitus
- Thyroid disease requiring treatment in the past 12 months
- Serious angioedema within the past 3 years
- Uncontrolled hypertension
- Bleeding disorder
- Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
- Seizure disorder requiring medication within the past 3 years
- Asplenia
- Mental illness that would interfere with compliance with the protocol
- Other conditions that, in the judgment of the investigator, would interfere with the study
- Pregnant or breastfeeding
Where it is running
- Johns Hopkins University — Baltimore, Maryland, United States
- New York Blood Center - Union Square — New York, New York, United States
- Columbia University — New York, New York, United States
- University of Rochester — Rochester, New York, United States
- New York Blood Center - Bronx — The Bronx, New York, United States
- Vanderbilt University — Nashville, Tennessee, United States
- Botswana HIV Vaccine Clinical Eval. Ctr, Princess — Gaborone, Botswana
- Perinatal HIV Research Unit, Chris Hani Baragwanat — Bertsham, South Africa
Full record on ClinicalTrials.gov
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