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Sponsored by: |
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: | NCT00076817 |
The purpose of this study is to determine the safety of and immune system response to the ALVAC-HIV (vCP205) vaccine when it is injected either into the groin area or into the arm. The goal is to determine if injecting the vaccine into the groin area produces a better immune response in the lining of the rectum.
Condition | Intervention | Phase |
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HIV Infections HIV Seronegativity |
Biological: ALVAC-HIV (vCP205) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Factorial Assignment, Safety Study |
Official Title: | A Phase I Double Blind Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of the Aventis Pasteur ALVAC-HIV (vCP205) Administered to the Groin Area Versus the Deltoid Area |
Enrollment: | 18 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | September 2008 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive vaccine injections in the groin area or the upper arm
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Biological: ALVAC-HIV (vCP205)
Canarypox virus vector vaccine
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2: Placebo Comparator
Participants will receive vaccine placebo injections in the groin area or the upper arm
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Biological: ALVAC-HIV (vCP205)
Canarypox virus vector vaccine placbo
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HIV is most commonly transmitted via a mucosal surface. The mucosal lining is a potential site of both humoral and cellular protection through the activity of B lymphocytes, activated memory T lymphocytes, secretory IgA, and antigen presenting cells. In addition to systemic immunity, a preventive HIV vaccine should induce immune responses at the mucosal surfaces that are portals of HIV entry into the body.
Targeted lymph node immunization involves vaccine injection into the subcutaneous tissue near a lymph node. This strategy has proven effective in the simian immunodeficiency virus (SIV)/rhesus macaque model. The iliac and inguinal lymph nodes in the groin are the primary draining lymph nodes of the genitourinary and rectal tracts. This study will evaluate and compare the safety and immunogenicity of ALVAC-HIV (vCP205) when administered subcutaneously in the groin and intramuscularly in the deltoid region. ALVAC-HIV (vCP205) is a canarypox virus vector vaccine expressing portions of the gp120, Gag, and Pol genes.
Participants in this study will be randomly assigned to receive vaccine or placebo injections in the groin area or the upper arm. All participants will have three baseline visits for blood tests and sigmoidoscopies to measure baseline immune functions. After these visits, participants will receive weekly injections for 4 weeks. Groin injections will be given subcutaneously (under the skin) and upper arm injections will be given intramuscularly (into the muscle). Participants will have follow-up visits 5 and 11 months after the last immunization. Participants will have blood draws and sigmoidoscopies and will receive HIV risk reduction counseling throughout the study. Total length of participation will be approximately 14 months. Participants may continue to contact the study for HIV testing and study-related concerns for 1 year after study participation.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
United States, California | |
UCLA Center for HIV and Digestive Diseases | |
Los Angeles, California, United States, 90095-7019 |
Principal Investigator: | Peter Anton, MD | University of California, Los Angeles |
Responsible Party: | Center for HIV and Digestive Diseases ( Peter Anton, MD ) |
Study ID Numbers: | 5R01AI050467-03, UCLA MIG-003, 5 R01 AI050467-03 |
Study First Received: | February 3, 2004 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00076817 |
Health Authority: | United States: Food and Drug Administration |
HIV Preventive Vaccine ALVAC Vaccine Immunization Site Deltoid |
Groin Targeted Inguinal Lymph Node TILN |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |