HIV Infections Clinical Trial
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
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | September 2008 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria - HIV uninfected - Low risk for acquiring HIV-1 (no sexually transmitted disease within 1 year of study entry, no history of injection drug use, no sex with an HIV infected individual or active injection drug user within 6 months of study entry, no unsafe sexual activity with unknown partners) or mutually monogamous relationship with a known HIV seronegative partner (per report) for 6 months prior to study entry - Willing to abstain from receptive anal intercourse during the 14 months of the study - Available for follow-up during the 14 months of the study - Acceptable methods of contraception Exclusion Criteria - Pregnant or lactating woman - Allergy to eggs or neomycin - Live attenuated vaccines within 60 days of study. Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 1 month prior to study immunizations. - Gastrointestinal complaints such as inflammatory bowel disease or chronic diarrhea - Immunosuppression of any type, including those related to lupus, rheumatoid arthritis, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, and therapy with alkylating agents, antimetabolites, or radiation - Use of immunosuppressive medications within 6 months prior to study entry - Thyroid disease - Unstable asthma - Exposure to or active tuberculosis - Seizure disorders - Bleeding disorders - Splenectomy - Hypertension (blood pressure less than 150/100 if on medication) - Medical or psychiatric condition or occupational responsibilities which preclude participant's compliance with the study; specifically excluded are people with a history of suicide attempts, recent suicidal ideation, or who have past or present psychosis. - Received HIV vaccines or placebo in a prior HIV vaccine trial - Blood products within 120 days prior to study entry - Immunoglobulin within 60 days prior to study entry - Anaphylaxis or other serious adverse reactions to vaccines - Serious allergic reaction to any substance requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension) - Nonprescribed injection drug use - Investigational research agents within 30 days prior to study entry |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | UCLA Center for HIV and Digestive Diseases | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of administering vCP205 vaccinations to healthy adult individuals | Throughout study | Yes | |
Secondary | Immunogenicity of SC vaccination with four doses of vCP205 administered in the groin area versus four doses administered IM in the deltoid region, as measured by CTL activity directed to canarypox and HIV-1 env, gag and pol gene products | Throughout study | No | |
Secondary | Immunogenicity of SC vaccination with four doses of vCP205 administered in the groin area versus four doses administered IM in the deltoid region, as measured by anti-HIV-1 directed CD4+ T cell proliferative response to soluble p24 antigen | Throughout study | No | |
Secondary | Immunogenicity of SC vaccination with four doses of vCP205 administered in the groin area versus four doses administered IM in the deltoid region, as measured by CD8+ T cell specificity for HIV-1 epitopes | Throughout study | No |
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