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
gp160 Vaccine (Immuno-AG)
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 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 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 60 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 Patients must be: Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study. Available for 2 years of follow-up. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: History of positive PPD (tuberculin test) and abnormal chest x-ray. Positive syphilis serology (e.g., RPR). Positive for circulating hepatitis B surface antigen. Patients with the following are excluded: They or their sexual partners have identifiable high-risk behavior for HIV infection. History of immunodeficiency or chronic illness. Evidence of psychological or psychiatric problems that may lead to noncompliance. Prior Medication: Excluded: Immunosuppressive medications. Prior Treatment: Excluded: Blood transfusions or cryoprecipitates within 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 3 locations
St. Louis Univ. School of Medicine AVEG
St Louis, United StatesOpen St. Louis Univ. School of Medicine AVEG in Google MapsUniv. of Rochester AVEG
Rochester, United StatesVanderbilt Univ. Hosp. AVEG
Nashville, United States