Status:

COMPLETED

A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines in Vaccinia-Naive Individuals

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18-60 years

Phase:

PHASE1

Brief Summary

Primary: To determine whether combination vaccination, i.e., priming with a vaccinia recombinant-containing HIV envelope (HIVAC-1e) followed by boosting with a recombinant subunit envelope protein (gp...

Detailed Description

Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting with subunit envelope proteins offers the most promising strategy to date for a safe and immunogenic vaccine...

Eligibility Criteria

Inclusion Criteria

Subjects must have:

  • Normal history and physical exam.
  • Negative HIV screening by ELISA, Western blot, and p24 antigen (PBMC HIV culture or HIV-specific PCR can be substituted for Western blot and p24 antigen).
  • No history of smallpox (vaccinia) vaccination.
  • Normal urinalysis.
  • Absolute CD4 count = or > 500 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Subjects with the following conditions are excluded:

  • Hepatitis B surface antigenemia.
  • Medical or psychiatric condition that precludes compliance with the protocol.

Subjects with the following prior conditions are excluded:

  • History of immunodeficiency or chronic illness.
  • Eczema within the past year.

Prior Medication:

Excluded:

  • Prior experimental HIV vaccine.
  • Prior smallpox vaccine.
  • Immunoglobulin administration within 2 months prior to enrollment.
  • Any experimental agent within 2 months prior to enrollment.
  • History of use of immunosuppressive medications.

Prior Treatment:

Excluded:

  • Blood or blood product transfusion within the past 6 months.

    1. Current high risk for HIV transmission (persons previously at high risk for HIV transmission can be enrolled provided they have a negative HIV screening and no high-risk behavior has been practiced within the last 6 months).

  • Household contact with anyone who is pregnant, has eczema, is less than 12 months of age, or has immunodeficiency disease or is using immunosuppressive medications.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

December 1 1994

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT00001026

End Date

December 1 1994

Last Update

November 4 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Univ. of Rochester AVEG

Rochester, New York, United States, 14642

2

UW - Seattle AVEG

Seattle, Washington, United States, 98144

A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines in Vaccinia-Naive Individuals | DecenTrialz