Safety of and Immune Response to an HIV-1 Subtype C Vaccine (AVX101) in HIV Uninfected Adults
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV Preventive Vaccine
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Johns Hopkins University
- New York Blood Center - Bronx
- New York Blood Center - Union Square
- Columbia University
- University of Rochester
- Vanderbilt University
- Botswana HIV Vaccine Clinical Eval. Ctr, Princess
- Perinatal HIV Research Unit, Chris Hani Baragwanat
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
1 x 10^5 IU dose
1 x 10^6 IU dose
1 x 10^7 IU dose
1 x 10^8 IU dose
Placebo
Vaccine dose of 1 x 10^5 IU per injection
Vaccine dose of 1 x 10^6 IU per injection
Vaccine dose of 1 x 10^7 IU per injection
Vaccine dose of 1 x 10^8 IU per injection
phosphate buffered saline, pH 7.2, HSA, sodium gluconate, and sucrose