A Phase I Clinical Trial to Evaluate:Part A. The Safety and Immunogenicity of Two Dose Levels of SF-2 gp120 (CHO) With or Without MTP-PE Adjuvant in the MF59 Emulsion Part B. The Safety and Immunogenicity of Five Monthly Doses of 50 mcg gp120 Protein in MF59 Emulsion (Without MTP-PE) Versus the Emulsion Control
rgp120/HIV-1 SF-2
+ MTP-PE/MF59
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Prevention Study
Summary
One experimental AIDS vaccine is the gp120 vaccine. The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen. Antibodies directed against gp120 can neutralize HIV-1, and gp120 can also stimulate certain types of cell-mediated immune responses. Because many immunogens, including candidate HIV vaccines, may evoke relatively weak immune responses, the use of adjuvants, or substances that augment immune responses to vaccines, is of interest. MTP-PE/MF59, composed of the immunomodulator MTP-PE combined with MF59 emulsion, appears to be a promising adjuvant and has been selected for studies with the gp120 vaccine. In Part A, 32 volunteers (eight on each of four treatment arms) are randomized to receive one of two doses (15 or 50 mcg) of gp120 vaccine with either MTP-PE/MF59 adjuvant emulsion or MF59 emulsion alone. The volunteers receive three IM injections at 0, 1, and 6 months. In Part B, 16 female volunteers (eight on each of two treatment arms) are randomized to receive either MF59 emulsion alone (placebo) or MF59 emulsion plus gp120 vaccine (50 mcg). Volunteers receive five IM injections at monthly intervals.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 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 have: Normal history and physical exam. No identifiable high-risk behavior for HIV infection. Negative ELISA for HIV. Normal cell-mediated immune responses using Merieux skin test. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Significant evidence of depression. Positive syphilis serology (e.g., RPR) that is documented not to be a false positive or from a remote (> 6 months) treated infection. Circulating Hepatitis B antigenemia. More than two sexual partners, or sexual contact with a high-risk partner, within the past 6 months. Patients with the following prior conditions are excluded: History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. Significant evidence of depression or under treatment for psychiatric problems within the past year. History of anaphylaxis or other adverse vaccine reactions. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) within the past 6 months. Prior Medication: Excluded: Immunoglobulin or vaccines within the past 2 months. Experimental agents within the past 30 days. Prior Treatment: Excluded: Blood transfusions or cryoprecipitates within the past 3 months. Risk Behavior: Excluded: History of IV drug use within the past year. More than two sexual partners, or sexual contact with a high-risk partner, 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 4 locations
St Louis Univ School of Medicine
St Louis, United StatesOpen St Louis Univ School of Medicine in Google MapsUniv of Pennsylvania at Philadelphia
Philadelphia, United StatesVanderbilt Univ Hosp
Nashville, United StatesChildren's Hospital & Medical Center / Seattle ACTU
Seattle, United States