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

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV Preventive Vaccine, AIDS Vaccines, Gene Products, gag, HIV-1, Dose-Response Relationship, Immunologic, Injections, Subcutaneous
Eligibility Criteria
Inclusion Criteria 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 Exclusion Criteria 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
Sites / Locations
- Johns Hopkins University
- New York Blood Ctr- Union Square
- Columbia University
- University of Rochester Medical Center
- Vanderbilt University
- SAAVI Vaccine Research Unit
- Chris Hani Baragwanath Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
1 x 10^4 IU dose
1 x 10^5 IU dose
Placebo
Vaccine dose of 1 x 10^4 IU per injection
Vaccine dose of 1 x 10^5 IU per injection