A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (VaxSyn)

NCT00000631 | Completed Phase 1

• 2 other identifiers: AVEG 002B10539
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Primary: To determine whether additional boosting with soluble recombinant gp160 vaccine (VaxSyn) after priming with a vaccinia-HIV envelope recombinant (HIVAC-1e) provides a significant advantage in the degree and duration of immunogenicity. Secondary: To learn more about the safety of the combination use of the two HIV envelope vaccines in the study (VaxSyn and HIVAC-1e). Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration.

Conditions

HIV Infections

Keywords

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

Interventions

HIVAC-1e BIOLOGICAL

gp160 Vaccine (MicroGeneSys) BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• Patients must have:
• Normal history and physical exam.
• Negative ELISA for HIV.
• Negative HIV p24 antigen test.
• Normal urinalysis.
• Prior Medication: Required:
• Two prior doses of HIVAC-1e (or DryVax) and two prior doses of gp160 vaccine.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• Risk factors for HIV infection including active intravenous drug use and more than 2 sexual partners.
• History of immunodeficiency or chronic illness.
• Hypersensitivity to insects.
• Medical or psychiatric condition that makes it unlikely the patient will comply with the protocol.
• Patients with the following prior conditions are excluded:
• History of immunodeficiency or chronic illness.
• Prior Medication:
• Excluded:
• Immunosuppressive medications.
• Prior Treatment:
• Excluded:
• Blood or blood product transfusion within the past 6 months.
• Risk Behavior: Excluded:

Sponsors & Collaborators

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

Study Sites (1)

Children's Hospital & Medical Center / Seattle ACTU

Seattle, Washington, 981050371, United States

Location

Related Publications (7)

• McElrath MJ, Corey L, Greenberg PD. Evaluation of cytotoxic T cell responses to candidate HIV-1 vaccines in HIV-1-uninfected individuals. AIDS Res Hum Retroviruses. 1994;10 Suppl 2:S69-72.

  PMID: 7865336 BACKGROUND

• Kent SJ, Greenberg PD, Hoffman MC, Akridge RE, McElrath MJ. Antagonism of vaccine-induced HIV-1-specific CD4+ T cells by primary HIV-1 infection: potential mechanism of vaccine failure. J Immunol. 1997 Jan 15;158(2):807-15.

  PMID: 8992998 BACKGROUND

• Mosier DE, Gulizia RJ, MacIsaac PD, Corey L, Greenberg PD. Resistance to human immunodeficiency virus 1 infection of SCID mice reconstituted with peripheral blood leukocytes from donors vaccinated with vaccinia gp160 and recombinant gp160. Proc Natl Acad Sci U S A. 1993 Mar 15;90(6):2443-7. doi: 10.1073/pnas.90.6.2443.

  PMID: 8460155 BACKGROUND

• McElrath J, Peterson E, Dragavon J, Berger D, Hoffman M, Klucking S, Greenberg P, Corey L. Combination prime-boost approach to HIV vaccination in seronegative individuals: enhanced immunity with additional subunit gp160 protein boosting. Int Conf AIDS. 1992 Jul 19-24;8(1):Mo9 (abstract no MoB 0027)

  BACKGROUND

• McElrath MJ, Rabin M, Hoffman M, Klucking S, Garcia JV, Greenberg PD. Evaluation of human immunodeficiency virus type 1 (HIV-1)-specific cytotoxic T-lymphocyte responses utilizing B-lymphoblastoid cell lines transduced with the CD4 gene and infected with HIV-1. J Virol. 1994 Aug;68(8):5074-83. doi: 10.1128/JVI.68.8.5074-5083.1994.

  PMID: 8035507 BACKGROUND

• McElrath MJ, Corey L, Greenberg PD, Matthews TJ, Montefiori DC, Rowen L, Hood L, Mullins JI. Human immunodeficiency virus type 1 infection despite prior immunization with a recombinant envelope vaccine regimen. Proc Natl Acad Sci U S A. 1996 Apr 30;93(9):3972-7. doi: 10.1073/pnas.93.9.3972.

  PMID: 8633000 BACKGROUND

• Cooney EL, McElrath MJ, Corey L, Hu SL, Collier AC, Arditti D, Hoffman M, Coombs RW, Smith GE, Greenberg PD. Enhanced immunity to human immunodeficiency virus (HIV) envelope elicited by a combined vaccine regimen consisting of priming with a vaccinia recombinant expressing HIV envelope and boosting with gp160 protein. Proc Natl Acad Sci U S A. 1993 Mar 1;90(5):1882-6. doi: 10.1073/pnas.90.5.1882.

  PMID: 8446603 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Vaccinia

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

Study Officials

• Corey L

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• 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: November 2, 2021

Record last verified: 2021-10

Locations

US (1)