Safety and Effectiveness of Administering an HIV Vaccine in the Groin Versus the Arm
Completed · Phase 1
Conditions studied: HIV Infections, HIV Seronegativity
In brief
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.
Key facts
- Study ID
- NCT00076817
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 18
- Starts
- 2006-06-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2012-10-29
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UCLA Center for HIV and Digestive Diseases — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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