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A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers Clinical research trials and A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers 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 measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers. A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers clinical trial. Subjects typically recieve the finest healthcare available for their A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers  A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers
A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant emulsion versus MF59 alone in HIV-negative volunteers. One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.
Details: One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant. Healthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0, 1, 6, 9, 10 and 12 (was months 0, 1, 6 and 10, amended 12/19/96).
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Volunteers must have: - Normal history and physical exam. - HIV negativity. - Absolute CD4 count >= 400 cells/mm3. - Normal urine dipstick with esterase and nitrite. - Lower risk sexual behavior. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: - Positive hepatitis B surface antigen. - Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance. - Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible. - Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible. Subjects with the following prior conditions are excluded: - History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. - History of anaphylaxis or other serious adverse reactions to vaccines. - History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension). - Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance. - History of cancer unless there has been surgical excision that is considered to have achieved cure. Prior Medication: Excluded: - Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations. - Experimental agents within 30 days prior to study entry. - Prior HIV vaccines. Prior Treatment: Excluded: - Blood products or immunoglobulin within the past 6 months. Identifiable high-risk behavior for HIV infection, including: - History of injection drug use within past 12 months. - Higher risk sexual behavior.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
CoreyL, Study Chair,
St Louis Univ School of Medicine
St. Louis, Missouri, 63104
United States
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Univ of Washington / Pacific Med Ctr
Seattle, Washington, 98144
United States
Johns Hopkins Univ / School of Hygiene & Public Health
Baltimore, Maryland, 212051901
United States
Additional Information:
Study ID Numbers: AVEG 024;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000832
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3. A Study of Zidovudine Plus Interleukin-2 in HIV-Infected Patients Who Have No Symptoms of Infection But Who Have Tender Lymph Nodes
4. Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune System's Response to HIV
5. Health Values and Spirituality in Veterans with HIV/AIDS
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A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers
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