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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Page 1 of 1 (3 locations)

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