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Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines Clinical research trials and Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines. Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines clinical trial. Test subjects typically receive the most expert healthcare available for their Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines  Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines
Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine the safety and immune system response to the TBC-3B HIV vaccine when it is injected either into the groin area or into the arm. The goal is to determine which injection site is better at producing a particular type of immune response. This study is not evaluating the effectiveness of the vaccine, so volunteers must maintain low risk behavior for HIV transmission throughout the study.
Details: The goal of this vaccination study is to evaluate the safety and immunogenicity of the Therion Biologic Corporation (Cambridge, MA) TBC-3B vaccine. TBC-3B consists of live, recombinant vaccinia virus expressing the env and gag/pol genes of HIV-1 strain IIIB. TBC-3B will be administered by subcutaneous injection in the groin and in the deltoid region, with the aim of determining which site is better at inducing mucosal immune responses. Because the groin area drains to the inguinal lymph nodes, vaccines given there may stimulate local immunologic activity in the draining rectal mucosa as well as systemic immunologic activity in the blood. Volunteers will be followed for 20 months. The first 2 months of the study will be an evaluation of volunteers’ normal immune function. Volunteers will then be randomly selected to receive the TBC-3B experimental HIV vaccine in either the groin area or in the deltoid region. Neither volunteers nor study personnel will know which group the volunteer will be in until the day of the first immunization. All volunteers will receive TBC-3B. During the 20 months of the study, volunteers will be asked to donate blood up to 14 times, undergo seven flexible sigmoidoscopies with biopsies, and receive three pairs of vaccine injections. For up to 36 days after each experimental vaccination, volunteers will be asked to abstain from activity that might spread the virus in the vaccine and put others at risk. Volunteers will receive specific instructions on how to avoid these risks. Volunteers will also be asked not to engage in receptive anal intercourse during the study.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/33 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV uninfected - Low risk for 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 subject report) for 6 months prior to study entry - Born after 1970 - Willingness to abstain from sexual activity for up to 30 days after each vaccination - Willingness to abstain from receptive anal intercourse during the 20 months of the study - Available for follow-up during the 20 month duration of the study - Acceptable methods of contraception Exclusion Criteria - Immunosuppression of any type, including those related to lupus, rheumatoid arthritis, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, and therapy with alkylating agents, antimetabolites, radiation, or large doses of corticosteroids - Gastrointestinal complaints such as inflammatory bowel disease or chronic diarrhea - Medical or psychiatric condition or occupational responsibilities which preclude volunteer’s compliance with the protocol; specifically excluded are people with a history of suicide attempts, recent suicidal ideation, or who have past or present psychosis - Prior smallpox or vaccinia-based vaccination - 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 TBC-3B immunizations. - 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) - Sexually transmitted disease in the year prior to study entry - Genital HSV (herpes) or other ulcerative genital lesions - Active HBV (hepatitis B) or HCV (hepatitis C) infection - Nonprescribed injection drug use - Pregnant or lactating women - Acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, eczema) - Use of experimental agents within 30 days prior to study - Household contacts with or ongoing occupational exposure to any of the following: pregnant women; children < 12 months of age; people with acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, eczema); people with an immunodeficiency or using immunosuppressive medications
Total Enrollment: 12
Location and Contact Information:
Overall Study Official:
PeterAnton, Principal Investigator, University of California at Los Angeles
University of California at Los Angelos Center for HIV and Digestive Diseases
Los Angeles, California, 90095-7019
United States
Additional Information:
Study ID Numbers: R01 AI 50467; UCLA MIG-001
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056745
Other Hiv Infections Studies:
1. A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications
2. Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)
3. Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients
4. Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
5. A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines
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