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A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59 conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59 Clinical research trials and A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59 health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59 Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59 clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59 condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59  A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
For Condition: HIV Infections,HIV Seronegativity
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Biocine
Synopsis: To evaluate the safety and immune response of 100 mcg Env 2-3 antigen administered on days 0, 30, 180, and 365. Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.
Details: Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest. Twelve healthy volunteers receive injections of 100 mcg Env 2-3 in MF59 emulsion and two volunteers receive MF59 only on days 0, 30, 180, and 365. Follow-up continues for 6 months after the last injection.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Safety Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Subjects are: - Normal, healthy adults (by history and physical examination) who fully comprehend the purpose and details of the study. Exclusion Criteria Co-existing Condition: Subjects with the following conditions or symptoms are excluded: - Positive syphilis serology (such as VDRL) unless positive test is due to a documented clinical event that occurred and was treated 5 or more years prior to enrollment. - Circulating hepatitis B antigenemia. Subjects with the following prior conditions are excluded: - History of immunodeficiency, chronic illness, or autoimmune disease. - Evidence of depression or under treatment for psychiatric problems during the past year. Prior Medication: Excluded: - Immunosuppressive medications. Prior Treatment: Excluded: - Blood transfusions or cryoprecipitates within the past 6 months. Identifiable high-risk behavior for HIV infection, including: - history of intravenous drug use; syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the last 6 months; more than two sexual partners, or sexual contact with a high-risk partner, in the preceding 6 months.
Total Enrollment: 14
Location and Contact Information:
Overall Study Official:
DolinR, Study Chair,
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Additional Information:
Study ID Numbers: AVEG 005C;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000632
Other Hiv Infections Studies:
1. A Blood Test to Look at Cells of the Immune System in Healthy Children
2. The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More than 12 Weeks
3. Comparison of Three Different Initial Treatments, Not Using Protease Inhibitors, for HIV Infection
4. A Pilot Study of Adherence to Oral Medication and Health Beliefs of Adolescents with HIV and their Mothers
5. A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Rochester Clinical Trials
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
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