A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived HIV-1 Recombinant Envelope Glycoprotein (gp160)

NCT00000968 | Completed Phase 1

• 2 other identifiers: AVEG 00410543
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) in human volunteers; to evaluate the immunogenicity of this preparation in human volunteers. Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; Drug Evaluation; HIV Envelope Protein gp160; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine

Interventions

gp160 Vaccine (Immuno-AG) BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• Patients must be:
• Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
• Available for 1 year of follow-up.

You may not qualify if:

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• History of positive PPD (tuberculin test).
• Positive syphilis serology (e.g., VDRL).
• Positive for circulating hepatitis B antigen.
• Patients with the following are excluded:
• They or their sexual partners have identifiable high-risk behavior for HIV infection.
• History of immunodeficiency or chronic illness.
• Evidence of depression or under treatment for psychiatric problems during the past year.
• Prior Medication:
• Excluded:
• Immunosuppressive medications.
• Prior Treatment:
• Excluded:
• Blood transfusions or cryoprecipitates within the past 6 months.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Immuno-US: collaborator

Study Sites (1)

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, 63104, United States

Location

Related Publications (7)

• Keefer MC, Wolff M, Gorse GJ, Graham BS, Corey L, Clements-Mann ML, Verani-Ketter N, Erb S, Smith CM, Belshe RB, Wagner LJ, McElrath MJ, Schwartz DH, Fast P. Safety profile of phase I and II preventive HIV type 1 envelope vaccination: experience of the NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1997 Sep 20;13(14):1163-77. doi: 10.1089/aid.1997.13.1163.

  PMID: 9310283 BACKGROUND

• Belshe RB, Clements ML, Keefer MC, Graham BS, Corey L, Sposto R, Wescott S, Lawrence D. Interpreting HIV serodiagnostic test results in the 1990s: social risks of HIV vaccine studies in uninfected volunteers. NIAID AIDS Vaccine Clinical Trials Group. Ann Intern Med. 1994 Oct 15;121(8):584-9. doi: 10.7326/0003-4819-121-8-199410150-00005.

  PMID: 8085690 BACKGROUND

• Stanhope PE, Clements ML, Siliciano RF. Human CD4+ cytolytic T lymphocyte responses to a human immunodeficiency virus type 1 gp160 subunit vaccine. J Infect Dis. 1993 Jul;168(1):92-100. doi: 10.1093/infdis/168.1.92.

  PMID: 8099941 BACKGROUND

• VanCott TC, Bethke FR, Burke DS, Redfield RR, Birx DL. Lack of induction of antibodies specific for conserved, discontinuous epitopes of HIV-1 envelope glycoprotein by candidate AIDS vaccines. J Immunol. 1995 Oct 15;155(8):4100-10.

  PMID: 7561123 BACKGROUND

• Belshe RB, Clements ML, Dolin R, Graham BS, McElrath J, Gorse GJ, Schwartz D, Keefer MC, Wright P, Corey L, et al. Safety and immunogenicity of a fully glycosylated recombinant gp160 human immunodeficiency virus type 1 vaccine in subjects at low risk of infection. National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group Network. J Infect Dis. 1993 Dec;168(6):1387-95. doi: 10.1093/infdis/168.6.1387.

  PMID: 8245523 BACKGROUND

• Gorse GJ, Patel GB, Newman FK, Mandava M, Belshe RB. Recombinant gp160 vaccination schedule and MHC HLA type as factors influencing cellular responses to HIV-1 envelope glycoprotein. NIAID AIDS Vaccine Clinical Trials Network. Vaccine. 1995 Sep;13(13):1170-9. doi: 10.1016/0264-410x(95)00020-2.

  PMID: 8578800 BACKGROUND

• Gorse GJ, Rogers JH, Perry JE, Newman FK, Frey SE, Patel GB, Belshe RB. HIV-1 recombinant gp160 vaccine induced antibodies in serum and saliva. The NIAID AIDS Vaccine Clinical Trials Network. Vaccine. 1995 Feb;13(2):209-14. doi: 10.1016/0264-410x(95)93138-y.

  PMID: 7625118 BACKGROUND

MeSH Terms

Conditions

HIV Infections

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

Study Officials

• Belshe R

  STUDY CHAIR

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: August 1, 1993
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (1)