HIV Infections Clinical Trial
Official title:
A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59
NCT number | NCT00000972 |
Other study ID # | AVEG 005A/B |
Secondary ID | 1054610547 |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Est. completion date | April 1992 |
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the safety of a fixed antigen dose with an increasing dose of adjuvant (MTP-PE/MF59, a substance to enhance the immune response to vaccine) in volunteers. To evaluate local and systemic reactions (Part A). To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PE/MF59 in volunteers (Part B). The vaccine Env 2-3 is created from one of the viral proteins that make up HIV called envelope glycoprotein gp120. A problem with many immunogens, including candidate HIV vaccines, is that they may evoke relatively weak immune responses, particularly in humans and in nonhuman primates. Thus, there is considerable interest in the development of "adjuvants" (substances that augment immune responses to vaccines). MTP-PE/MF59 is an adjuvant that appears to be particularly promising, and is selected for the studies with this HIV vaccine candidate.
Status | Completed |
Enrollment | 64 |
Est. completion date | April 1992 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria Volunteers are: - Normal, healthy adults (by history and physical examination) who fully comprehend the purpose and details of the study. Part A: - Available for 60 days. Part B: - Available for 1 year of follow-up. Exclusion Criteria Co-existing Condition: Volunteers with the following conditions or symptoms are excluded: Part B: - Positive syphilis serology (such as VDRL) unless positive test is due to a documented clinical event that occurred and was treated 5 or more years prior to enrollment. Circulating hepatitis B antigenemia. - Volunteers with the following are excluded: - History of immunodeficiency, chronic illness, autoimmune disease. - Evidence of depression or under treatment for psychiatric problems during the past year. Prior Medication: Excluded: - Immunosuppressive medications. Prior Treatment: Excluded: Part B: - Blood transfusion or cryoprecipitates within the past 6 months. Risk Behavior: Excluded: Part B: Identifiable high-risk behavior for HIV infection, including: - history of intravenous drug use; syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the last 6 months; more than two sexual partners, or sexual contact with a high-risk partner, in the preceding 6 months. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt Univ. Hosp. AVEG | Nashville | Tennessee |
United States | Univ. of Rochester AVEG | Rochester | New York |
United States | UW - Seattle AVEG | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Biocine |
United States,
Evans TG, Fitzgerald T, Gibbons DC, Keefer MC, Soucier H. Th1/Th2 cytokine responses following HIV-1 immunization in seronegative volunteers. The AIDS Vaccine Evaluation Group. Clin Exp Immunol. 1998 Feb;111(2):243-50. — View Citation
Keefer MC, Graham BS, McElrath MJ, Matthews TJ, Stablein DM, Corey L, Wright PF, Lawrence D, Fast PE, Weinhold K, Hsieh RH, Chernoff D, Dekker C, Dolin R. Safety and immunogenicity of Env 2-3, a human immunodeficiency virus type 1 candidate vaccine, in combination with a novel adjuvant, MTP-PE/MF59. NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1996 May 20;12(8):683-93. — View Citation
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