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A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults Clinical research trials and A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults. A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults  A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
For Condition: HIV Infections,HIV Seronegativity
Status: Completed
Sponsor(s): Chiron Corporation ,
Synopsis: To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.
Details: This study evaluates the safety and immunogenicity of the Chiron vaccine HIV p24/MF59. In Part A, 15 volunteers are randomly assigned to receive either HIV p24/MF59 or a placebo at 0, 1, and 6 months. 10 volunteers receive the vaccine and 5 volunteers receive the placebo. If no serious adverse events are observed within 1 week after the first injection in these first 15 patients, Part B is initiated. In Part B, 25 volunteers are randomly assigned to receive HIV p24/MF59 or a placebo at 0, 1, and 6 months. 20 volunteers receive the vaccine and 5 volunteers receive the placebo.
Eligibility:
Study Type: Interventional, Prevention, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Volunteers must have: - Good health as determined by medical history, physical examination, and clinical judgment. - Negative serology for HIV infection as determined by licensed HIV ELISA test performed within 6 weeks prior to first immunization. - In vitro Epstein-Barr virus-immortalized cell line from peripheral blood can be established (required for selected Part B volunteers only). Exclusion Criteria Co-existing Condition: Volunteers with the following symptoms or conditions are excluded: - Significant acute systemic infection. - Occupational or other responsibilities that would prevent completion of participation in the study. - Any condition that might interfere with the evaluation of the study objectives. Volunteers with the following prior conditions are excluded: - History of immunodeficiency, autoimmune disease, or any serious chronic illness. - Evidence of psychiatric or medical history or substance abuse that would adversely affect the volunteer's ability to participate in the trial. - History of anaphylaxis or other serious adverse reactions to vaccines or vaccine components. 1. Immunosuppressive medications. - Live, attenuated vaccine within 60 days of study entry. NOTE: - Medically indicated subunit or killed vaccines (e.g., influenza or pneumococcal) are not exclusionary but should be given at least 4 weeks before or after HIV immunizations to avoid potential confusion of adverse reactions. - Experimental agents within 30 days of study entry. - HIV vaccine or MF59 adjuvant. Blood products or immunoglobulins in the past 3 months. Engaging in high-risk behavior within 6 months of study entry, i.e.: - injection drug use, sexual intercourse without a condom with 4 or more partners or with known iv drug user or HIV+ partner, or newly acquired sexually-transmitted disease.
Total Enrollment: 40
Location and Contact Information:
Creighton Univ Med Ctr / Ped Infect Disease Div
Omaha, Nebraska, 68178
United States
Additional Information:
Study ID Numbers: 095; V24P1
Study Start Date:
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002204
Other Hiv Seronegativity Studies:
1. Carotid Artery Thickness in HIV Infected and Uninfected Adults
2. Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
3. HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults
4. HIV-1 Vaccine Test in Uninfected Adult Volunteers
5. Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda
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A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
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