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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1
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States, 37232
2
UW - Seattle AVEG
Seattle, Washington, United States, 981050371