Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Biocine
Conditions:
HIV Infections
HIV Seronegativity
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 re...
Detailed Description
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 ev...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 1992
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00000972
End Date
April 1 1992
Last Update
November 4 2021
Active Locations (3)
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1
Univ. of Rochester AVEG
Rochester, New York, United States, 14642
2
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States, 37232
3
UW - Seattle AVEG
Seattle, Washington, United States, 981050371