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

NCT00000746 | Completed Phase 1

• 3 other identifiers: AVEG 008AVEG Protocol 00810553
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity of the three subunit vaccines when administered as boosters. Secondary: To examine the safety of administering the individual subunit vaccines in combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone. In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; HIV-1; HIV Envelope Protein gp160; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine

Interventions

rgp120/HIV-1 SF-2 BIOLOGICAL

Env 2-3 BIOLOGICAL

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:

• 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).
• History of smallpox vaccination more than 5 years prior to enrollment.
• Normal urinalysis.
• Absolute CD4 count = or \> 500 cells/mm3.
• Prior Medication: Required:
• Vaccinia (smallpox) vaccination more than 5 years prior to study enrollment. Identifiable high-risk behavior for HIV infection as determined by screening questionnaire/interview.

You may not qualify if:

• Co-existing Condition:
• Subjects with the following symptoms or conditions are excluded:
• Household contacts who are pregnant, \< 12 months of age, have eczema, or have immunodeficiency disease or who use immunosuppressive medications.
• Hepatitis B surface antigenemia.
• Medical or psychiatric condition or occupational responsibilities that preclude compliance.
• 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.
• Immunoglobulin administration or use of experimental agent within the past 2 months.
• History of immunosuppressive medications.
• Prior Treatment:
• Excluded:

Sponsors & Collaborators

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

Study Sites (1)

JHU AVEG

Pittsburgh, Pennsylvania, 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

• Graham BS, Belshe RB, Clements ML, Dolin R, Corey L, Wright PF, Gorse GJ, Midthun K, Keefer MC, Roberts NJ Jr, et al. Vaccination of vaccinia-naive adults with human immunodeficiency virus type 1 gp160 recombinant vaccinia virus in a blinded, controlled, randomized clinical trial. The AIDS Vaccine Clinical Trials Network. J Infect Dis. 1992 Aug;166(2):244-52. doi: 10.1093/infdis/166.2.244.

  PMID: 1353102 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
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: July 1, 1994
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (1)