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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Protein Sciences Corporation |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000956 |
To evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequency of inoculation.
Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.
Condition | Intervention | Phase |
HIV Infections |
Biological: gp160 Vaccine (MicroGeneSys) |
Phase I |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Krestin PANVAC-V |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind, Safety Study |
Official Title: | A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160 |
Estimated Enrollment: | 25 |
Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.
In the initial phase of the study, 20 healthy volunteers receive 640 mcg gp160 vaccine and 5 healthy volunteers receive alum placebo. At least 30 days later, 20 additional volunteers receive 1280 mcg gp160 vaccine and 5 volunteers receive placebo. Injections are given on days 0, 30, 180, and 365.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
Subjects with the following prior conditions are excluded:
Prior Treatment:
Excluded:
Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:
United States, Missouri | |||||
St Louis Univ School of Medicine | |||||
St. Louis, Missouri, United States, 63104 | |||||
United States, New York | |||||
Univ of Rochester Med Ctr | |||||
Rochester, New York, United States, 14642 | |||||
United States, Pennsylvania | |||||
Univ of Pennsylvania at Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
United States, Tennessee | |||||
Vanderbilt Univ Hosp | |||||
Nashville, Tennessee, United States, 37232 | |||||
United States, Washington | |||||
Children's Hospital & Medical Center / Seattle ACTU | |||||
Seattle, Washington, United States, 981050371 |
National Institute of Allergy and Infectious Diseases (NIAID) |
Protein Sciences Corporation |
Study Chair: | Belshe R | |
Study Chair: | Clements ML | |
Study Chair: | Couch R | |
Study Chair: | Dolin R | |
Study Chair: | Levine M | |
Study Chair: | Wright P |
Study ID Numbers: | AVEG 003B |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000956 |
Health Authority: | United States: Federal Government |
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