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

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00063778

Run by

AlphaVax, Inc.

People needed

48

Starts

2003-07-01

Expected to finish

2005-07-01

Last updated by the study team

2012-07-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• HIV negative
• 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
• Access to participating site and available for follow-up during the 12 month study

You may not qualify if…

• HIV vaccines or placebos in prior HIV vaccine trial
• Measurable anti-VEE antibody
• High risk for HIV infection according to HVTN Risk Criteria
• 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
• Current tuberculosis prophylaxis or therapy
• Active syphilis
• Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
• Autoimmune disease or immunodeficiency
• Unstable asthma
• Type 1 or Type 2 Diabetes Mellitus
• Thyroid disease requiring treatment
• 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 judgement of the investigator, would interfere with the study
• Pregnant or breast-feeding

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States
• Columbia University — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• New York Blood Ctr- Union Square — The Bronx, New York, United States
• Vanderbilt University — Nashville, Tennessee, United States
• SAAVI Vaccine Research Unit — Durban, South Africa
• Chris Hani Baragwanath Hospital — Soweto, South Africa

Full record on ClinicalTrials.gov

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