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Sponsors and Collaborators: |
AlphaVax, Inc. National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00097838 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Biological: AVX101 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase I, Dose Escalation, Safety, and Immunogenicity Trial of an Alphavirus Replicon HIV-1 Subtype C Gag Vaccine (AVX101) in Healthy HIV-1 Uninfected Adult Participants |
Estimated Enrollment: | 96 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | June 2006 |
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 vaccine is critically important in controlling the spread of HIV in this part of the world. This study will determine the safety and immunogenicity of an alphavirus replicon HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults. This vaccine utilizes a propagation-defective replicon vector system derived from an attenuated strain of Venezuelan Equine Encephalitis (VEE) virus. The vaccine replicon expresses the gag gene from a South African subtype C isolate of HIV-1. Participants will be recruited in the United States, South Africa, and Botswana.
The study will last for 1 year. Participants will be enrolled sequentially, from lowest to highest dose of vaccine, into one of four groups. Groups will begin enrollment only following safety review of the previous group. Participants will be randomly assigned to receive active vaccine or placebo. During the study, participants will receive either 3 injections of one of four possible doses of the vaccine or 3 injections of placebo. Injections will be given at study entry and at Days 28 and 84. At screening, participants will undergo medical history assessment, a complete physical, HIV testing and counseling, and blood and urine collection; they will also be interviewed and asked to complete a questionnaire. After screening, there will be 8 study visits; the visits will occur at Days 14, 28, 42, 84, 98, 168, 273, and 364. Participants will be interviewed and asked to fill out a questionnaire at each study visit; participants will undergo a physical, additional HIV testing and counseling, and blood and urine collection at selected visits.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205-1901 | |
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642-0001 | |
New York Blood Center - Union Square | |
New York, New York, United States, 10003 | |
New York Blood Center - Bronx | |
Bronx, New York, United States, 10456 | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 | |
Botswana | |
Botswana HIV Vaccine Clinical Eval. Ctr, Princess | |
Gaborone, Botswana | |
South Africa | |
Perinatal HIV Research Unit, Chris Hani Baragwanat | |
Bertsham, South Africa, 2013 |
Study Chair: | Donald S. Burke, MD | Center for Immunization Research, Johns Hopkins School of Public Health |
Study Chair: | Salim Abdool Karim, MD, PhD | University of KwaZulu |
Study ID Numbers: | HVTN 059 |
Study First Received: | November 30, 2004 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00097838 |
Health Authority: | United States: Food and Drug Administration |
HIV Seronegativity HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |