Status:

COMPLETED

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in 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 and immune response of 100 mcg Env 2-3 antigen administered on days 0, 30, 180, and 365. Preliminary immunologic data from protocol VEU 005B show evidence of the development of...

Detailed Description

Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evalu...

Eligibility Criteria

Inclusion Criteria

Subjects are:

  • Normal, healthy adults (by history and physical examination) who fully comprehend the purpose and details of the study.

Exclusion Criteria

Co-existing Condition:

Subjects with the following conditions or symptoms are excluded:

  • 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.

Subjects with the following prior conditions are excluded:

  • History of immunodeficiency, chronic illness, or autoimmune disease.
  • Evidence of depression or under treatment for psychiatric problems during the past year.

Prior Medication:

Excluded:

  • Immunosuppressive medications.

Prior Treatment:

Excluded:

  • Blood transfusions or cryoprecipitates within the past 6 months.

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 :

May 1 1992

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT00000632

End Date

May 1 1992

Last Update

November 2 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