Status:
COMPLETED
Safety of and Immune Response to an HIV-1 Subtype C Vaccine (AVX101) in HIV Uninfected Adults
Lead Sponsor:
AlphaVax, Inc.
Collaborating Sponsors:
HIV Vaccine Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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, ...
Detailed Description
HIV-1 subtype C is the prevailing subtype of HIV found in sub-Saharan Africa and is primarily responsible for the HIV/AIDS epidemic in southern Africa. Thus, development of a preventive subtype C vacc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00097838
Start Date
October 1 2004
End Date
September 1 2009
Last Update
July 2 2012
Active Locations (8)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205-1901
2
New York Blood Center - Union Square
New York, New York, United States, 10003
3
Columbia University
New York, New York, United States, 10032
4
University of Rochester
Rochester, New York, United States, 14642-0001