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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1
Univ. of Rochester AVEG
Rochester, New York, United States, 14642
2
UW - Seattle AVEG
Seattle, Washington, United States, 98144