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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

This study is being conducted in two parts: Par...

Gender

ALL

Eligibility criteria

• • 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.