Status:
COMPLETED
Safety and Effectiveness of Administering an HIV Vaccine in the Groin Versus the Arm
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
HIV Seronegativity
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 dete...
Detailed Description
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 lymphoc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00076817
Start Date
June 1 2006
End Date
September 1 2008
Last Update
October 29 2012
Active Locations (1)
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1
UCLA Center for HIV and Digestive Diseases
Los Angeles, California, United States, 90095-7019