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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 vaccination result in a synergistic (added) response not predicted by just the addition of a second vaccination, and does this synergism depend on the unique priming effect of a vaccinia recombinant, or will any combination do?

Volunteers will be randomized to one of four groups. Group A (20 volunteers) will receive gp160 (VaxSyn) followed two months later by a repeat dose. Group B (20 volunt...

Gender

ALL

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.