Status:

COMPLETED

Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (gp160; VaxSyn)

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18-60 years

Phase:

PHASE1

Brief Summary

To determine if priming (giving the first vaccination) with a vaccinia recombinant (HIVAC-1e) provides a significant advantage in immunogenicity (production of antibodies) compared to priming with a s...

Detailed Description

Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines, HIVAC-1e and gp160. Specific questions to be addressed in this part of the study include: Does combination...

Eligibility Criteria

Inclusion Criteria

  • Volunteers must be healthy adults without high-risk behavior for HIV-1 infection and with history of smallpox vaccination more than 5 years prior to enrollment.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Identifiable high-risk behavior for HIV infection including active intravenous drug use and multiple sexual partners or sexual contact with high-risk partners within the past 6 months.
  • Eczema, active or within the past year.
  • Household contact with someone who is pregnant.
  • Household contact with children less than 12 years old.
  • Household contact with anyone with eczema.
  • Household contact with anyone with immunodeficiencies.
  • Hypersensitivity to insects.
  • Medical or psychiatric conditions that would make compliance unlikely.
  • Evidence of depression.

Patients with the following prior conditions are excluded:

  • History of immunodeficiency or chronic illness or use of immunosuppressive medications.
  • Blood or blood product transfusion within previous six months.
  • Eczema, active or within the past year.
  • Prior receipt of experimental HIV vaccine. [Specific other requirements are stated elsewhere in the record.]

Prior Treatment:

Excluded within 6 months prior to study entry:

  • Blood or blood product transfusions.

Risk Behavior:

Excluded:

  • Active intravenous drug use.
  • Syphilis, gonorrhea, or any sexually transmitted diseases including chlamydia or pelvic inflammatory disease within the past 6 months.
  • More than 2 sexual partners in the past 6 months or sexual contact with a high-risk partner.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

December 1 1992

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT00000630

End Date

December 1 1992

Last Update

October 27 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, United States, 37232

2

UW - Seattle AVEG

Seattle, Washington, United States, 981050371