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

NCT00000630 | Completed Phase 1

• 2 other identifiers: AVEG 002A10538
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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 soluble recombinant protein (gp160); to learn more about the safety of the combination use of the two HIV envelope vaccines utilized in the study. 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?

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; Vaccinia Virus; Viral Envelope Proteins; Acquired Immunodeficiency Syndrome; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine

Interventions

HIVAC-1e BIOLOGICAL

gp160 Vaccine (MicroGeneSys) BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, 37232, United States

Location

UW - Seattle AVEG

Seattle, Washington, 981050371, United States

Location

MeSH Terms

Conditions

HIV Infections; Vaccinia; Acquired Immunodeficiency Syndrome

Interventions

HIVAC-1e; VaxSyn HIV-1 (gp160) vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Poxviridae Infections; DNA Virus Infections; Slow Virus Diseases

Study Officials

• Koff W

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: December 1, 1992
• Last Updated: October 27, 2021

Record last verified: 2021-10

Locations

US (2)