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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Immuno-US |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001056 |
To determine the safety of and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) at a dose of 200 mcg in human volunteers; to evaluate duration of antibody response and its relationship to the dose and frequency of inoculation.
Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that the ultimate control of the disease depends on the development of safe and effective vaccines against HIV.
Condition | Intervention | Phase |
HIV Infections |
Biological: gp160 Vaccine (Immuno-AG) |
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 Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of a 200-Mcg Dose |
Estimated Enrollment: | 25 |
Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that the ultimate control of the disease depends on the development of safe and effective vaccines against HIV.
Healthy, adult volunteers without identifiable high-risk behavior for HIV-1 infection are randomly assigned to receive three injections of either 200 mcg gp160 vaccine or a placebo. At each participating site, four volunteers receive vaccine and two volunteers receive placebo. Primary immunization and two booster immunizations at day 30 and day 180 are done in an outpatient setting. Volunteers are closely monitored for the first 2 weeks postimmunization (primary and boosters), and extensively followed for 2 years. Volunteers may be offered an additional booster of the same preparation at 12 months.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Patients must be:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
United States, Maryland | |||||
Johns Hopkins Univ / School of Hygiene & Public Health | |||||
Baltimore, Maryland, United States, 212051901 | |||||
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 | |||||
Univ of Washington / Pacific Med Ctr | |||||
Seattle, Washington, United States, 98144 |
Study Chair: | Belshe R |
Study ID Numbers: | AVEG 004A |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001056 |
Health Authority: | United States: Federal Government |
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