A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

NCT00000956 | Completed Phase 1

• 2 other identifiers: AVEG 003B10542
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequency of inoculation. Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.

Conditions

HIV Infections

Keywords

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

Interventions

gp160 Vaccine (MicroGeneSys) BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must have:
• Normal history and physical exam.
• Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24).
• T4 count \>= 800 cells/mm3.
• Normal chest x-ray and urinalysis.
• Negative hepatitis B surface antigen.
• Negative HIV p24 antigen test.
• Normal skin reactivity by Merieux test.

You may not qualify if:

• Co-existing Condition:
• Subjects with the following symptoms or conditions are excluded:
• Positive PPD.
• Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease).
• Subjects with the following prior conditions are excluded:
• History of immunodeficiency, chronic illness, or use of immunosuppressive medications.
• Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
• Prior Treatment:
• Excluded:
• Prior blood transfusions or cryoprecipitates within the past 6 months.
• Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:
• Any history of IV drug use.
• Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
• More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Protein Sciences Corporation: collaborator

Study Sites (2)

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, 63104, United States

Location

JHU AVEG

Pittsburgh, Pennsylvania, United States

Location

Related Publications (6)

• 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

• 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

• Stanhope PE, Liu AY, Pavlat W, Pitha PM, Clements ML, Siliciano RF. An HIV-1 envelope protein vaccine elicits a functionally complex human CD4+ T cell response that includes cytolytic T lymphocytes. J Immunol. 1993 May 15;150(10):4672-86.

  PMID: 8097759 BACKGROUND

• Keefer MC, Graham BS, Belshe RB, Schwartz D, Corey L, Bolognesi DP, Stablein DM, Montefiori DC, McElrath MJ, Clements ML, et al. Studies of high doses of a human immunodeficiency virus type 1 recombinant glycoprotein 160 candidate vaccine in HIV type 1-seronegative humans. The AIDS Vaccine Clinical Trials Network. AIDS Res Hum Retroviruses. 1994 Dec;10(12):1713-23. doi: 10.1089/aid.1994.10.1713.

  PMID: 7888231 BACKGROUND

• De Santis C, Robbioni P, Longhi R, Lopalco L, Siccardi AG, Beretta A, Roberts NJ Jr. Cross-reactive response to human immunodeficiency virus type 1 (HIV-1) gp120 and HLA class I heavy chains induced by receipt of HIV-1-derived envelope vaccines. J Infect Dis. 1993 Dec;168(6):1396-403. doi: 10.1093/infdis/168.6.1396.

  PMID: 8245524 BACKGROUND

• Schwartz DH, Cosentino LM, Shirai A, Conover J, Daniel S, Klinman DM. Lack of correlation between the number of circulating B cells and the concentration of serum antibodies reactive with the HIV-1 envelope glycoprotein. J Acquir Immune Defic Syndr (1988). 1994 May;7(5):447-53.

  PMID: 8158537 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Vaccinia

Interventions

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

• Belshe R

  STUDY CHAIR

• Clements ML

  STUDY CHAIR

• Couch R

  STUDY CHAIR

• Dolin R

  STUDY CHAIR

• Levine M

  STUDY CHAIR

• Wright P

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

Record last verified: 2021-10

Locations

US (2)