A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
Data Collection
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Prevention Study
Summary
Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure. It is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against HIV. Healthy volunteers are injected on days 0, 30, and 180 with one of four preparations: gp160 vaccine (40 mcg), gp160 vaccine (80 mcg), hepatitis B vaccine, and placebo. The hepatitis B vaccine group will serve as an additional control for immunological evaluations. An optional fourth injection may be given 15-21 months following the initial inoculation.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.72 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Subjects must have: * Normal history and physical exam. * Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24). * T4 count \>= 800 cells/mm3. * Normal chest x-ray and urinalysis. * Negative surface antibody and core antibody for hepatitis B. * Negative hepatitis B surface antigen. * Negative HIV p24 antigen test. * Normal skin reactivity by Merieux test. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: * Positive PPD. * Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease). Subjects with the following prior conditions are excluded: * History of immunodeficiency, chronic illness, or use of immunosuppressive medications. * Prior hepatitis B vaccination. * Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. Prior Medication: Excluded: * Prior hepatitis B vaccine. Prior Treatment: Excluded: * Prior blood transfusions or cryoprecipitates within the past 6 months. Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including: * Any history of IV drug use. * Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. * More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Vanderbilt Univ. Hosp. AVEG
Nashville, United States