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Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda Clinical research trials and Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda. Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda clinical trial. Subjects often receive the most expert healthcare possible for their Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda  Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda
Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda
For Condition: HIV Seronegativity,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Joint Clinical Research Center,Uganda Virus Research Institute,Joint UN Programme on HIV/AIDS (UNAIDS),John E. Fogarty International Center (FIC),Case Western Reserve University
Synopsis: The purpose of this study is to see if it is safe to give ALVAC-HIV vCP205, a possible HIV vaccine, and to study the immune responses in adult HIV-1 uninfected volunteers. Uganda has been severely affected by HIV infection and AIDS and has been selected to participate in HIV-vaccine development. The HIV viruses commonly isolated from Uganda are 2 kinds that are not used in making current vaccines. Current vaccines generate several kinds of immune responses. Researchers would like to see if a response to the kind of virus in a current vaccine will also protect people from the viruses commonly found in Uganda.
Details: The African country of Uganda is severely affected by HIV infection and AIDS and has been selected by the World Health Organization to participate in HIV-vaccine development. The predominant HIV-1 strains isolated from Ugandans are members of clade A and clade D. The only vaccines available for human testing are based on envelope proteins from clade B and clade E viruses. ALVAC-HIV vCP205 is a second generation vaccine that can induce a humoral and cellular response against several antigens. The current study will attempt to extend these findings to determine if the vCP205 vaccine, when administered to Ugandans, can induce cytotoxic T-lymphocyte (CTL) responses that are reactive against the HIV strains prevalent in Uganda. Volunteers are randomized into 1 of 3 groups and receive either the candidate HIV-1 vaccine ALVAC-HIV vCP205, the experimental canarypox rabies vaccine ALVAC-RG, or placebo-ALVAC. Neither the volunteer nor his/her health care professional knows which preparation is being given. Volunteers receive 4 injections over a period of 6 months and are followed for up to 24 months. Clinical observations and monitoring of hematological, chemical, and immunologic parameters are done. Safety is evaluated by monitoring for local and systemic adverse reactions during the course of the trial. Comparative immunogenicity analyses are based on CTL responses to HIV and measures of binding and HIV-specific antibody responses. At each visit, volunteers are counseled on how to avoid HIV exposure and pregnancy.
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/40 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Volunteers may be eligible for this study if they: - Are 18 to 40 years of age. - Have a negative pregnancy test at time of entry and agree to use birth control for 1 month prior to the first injection and during active follow-up. - Have a normal history and physical examination. - Are negative for Hepatitis B. - Are HIV-negative. - Have blood cells that can be infected with Epstein-Barr virus. - Are available for follow-up for the study (24 months). Exclusion Criteria Volunteers will not be eligible for this study if they: - Have had a sexually transmitted disease or more than 1 sex partner during the previous 12 months. - Are pregnant or breast-feeding. - Have had immune diseases, chronic illness, or malignancy. Persons who had cancer that was surgically removed and are thought to be cured are eligible. - Have used medications that affect the immune system. - Have a medical or mental condition or job that may interfere with the study. - Have received certain live vaccines within 60 days of study. Other vaccines such as flu or pneumococcal are not excluded but should be received at least 2 weeks away from HIV immunizations. - Have used experimental agents within 30 days prior to study. - Have received any blood products within the last 6 months. - Have syphilis. - Have an HIV-positive partner. - Have tuberculosis. - Have had or currently have severe allergic reactions to vaccines, eggs or neomycin, or any other substance. that required hospitalization or other medical care. - Have been immunized or treated for rabies within 6 months of receiving injections. - Are poultry workers. - Have malaria that has not been treated or has not responded to treatment. - Have schistosomiasis.
Total Enrollment: 40
Location and Contact Information:
Overall Study Official:
RoyMugerwa, Principal Investigator,
Missie Allen
Research Triangle Park, North Carolina, 27709
United States
Additional Information:
Study ID Numbers: HIVNET 007;
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007423
Other Hiv Infections Studies:
1. A simplified Kaletra® (lopinavir/ritonavir)-based therapy versus a Sustiva® (efavirenz)-based standard of care in previously non-treated HIV-infected subjects
2. Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune)
3. A Study of Zidovudine in HIV-Infected Pregnant Women and Their Children
4. (Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC
5. Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s)
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Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda
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