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

NCT00001026 | Completed Phase 1

• 2 other identifiers: AVEG 01010555
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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 (gp160 or gp120), provides enhanced immunogenicity compared to subunit vaccination with the individual recombinant envelope proteins only. To compare the relative immunogenicity of a panel of HIV envelope subunit vaccines when administered as boosters following recombinant HIV-vaccinia priming. To evaluate the relative immunogenicity of one versus two doses of recombinant HIV-vaccinia prior to the subunit protein boost. Secondary: To examine the safety of administering the individual subunit vaccines in combination with the HIV envelope vaccinia recombinant, and to extend the population to whom these proteins have been administered. 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 in humans. This study will further examine the combination vaccine approach and define an optimal prime-boost strategy.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; HIV Envelope Protein gp160; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine

Interventions

gp160 Vaccine (Immuno-AG) BIOLOGICAL

rgp120/HIV-1IIIB BIOLOGICAL

rgp120/HIV-1MN BIOLOGICAL

rgp120/HIV-1 SF-2 BIOLOGICAL

HIVAC-1e BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

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

Study Sites (2)

Univ. of Rochester AVEG

Rochester, New York, 14642, United States

Location

UW - Seattle AVEG

Seattle, Washington, 98144, United States

Location

Related Publications (2)

• Clements ML, Corey L, Weinhold K, Schwartz D, Siliciano R, Matthews T, Hsieh R, Graham B, Keefer M, Gorse G, Zolla-Pazner S, Mascola J, Duliege A, Excler J, Tartaglia J, Paoletti E, Hu SL. HIV immunity induced by priming with canarypox or vaccinia-gp160 recombinants and boosting with rgp120. Inst of Hum Virol Annu Meet. 1996 Sept 7-13

  BACKGROUND

• Corey L, McElrath MJ, Weinhold K, Matthews T, Stablein D, Graham B, Keefer M, Schwartz D, Gorse G. Cytotoxic T cell and neutralizing antibody responses to human immunodeficiency virus type 1 envelope with a combination vaccine regimen. AIDS Vaccine Evaluation Group. J Infect Dis. 1998 Feb;177(2):301-9. doi: 10.1086/514202.

  PMID: 9466515 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Vaccinia

Interventions

HIVAC-1e

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• 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, 1994
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (2)