A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived HIV-1 Recombinant Envelope Glycoprotein (gp160)
NCT ID: NCT00000968
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
1993-08-31
Brief Summary
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Detailed Description
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Healthy, adult volunteers without identifiable high-risk behavior for HIV-1 infection are vaccinated. In phase 1, at each participating unit, four volunteers receive a dose of gp160 (12.5 mcg); two volunteers receive placebo. Volunteers are monitored 1 month before proceeding to the second phase. In phase 2, four volunteers receive gp160 (50 mcg); two volunteers receive placebo. Primary immunization and two booster immunizations at day 30 and day 180 are done in an outpatient setting. Volunteers are closely monitored for the first 2 weeks postimmunization (primary and boosters), and extensively followed for a minimum of 2 years. Volunteers may be offered an additional boost of the same preparation at 18 months. Per 07/28/92 amendment, 18 volunteers will receive 200 mcg gp160 in an unblinded study. Volunteers in phase 2 who received four doses of 50 mcg gp160 receive an additional boost of 200 mcg gp160 at 18-19 months post initial vaccination. Per 05/13/94 amendment, volunteers in phase 2 who received the additional 200 mcg boost receive another 200 mcg boost 18-24 months after the last injection (St. Louis University site only).
Conditions
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Keywords
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Study Design
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PREVENTION
DOUBLE
Interventions
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gp160 Vaccine (Immuno-AG)
Eligibility Criteria
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Inclusion Criteria
* Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
* Available for 1 year of follow-up.
Exclusion Criteria
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.
Risk Behavior: Excluded:
* High-risk behavior for HIV infection.
* History of intravenous drug use.
* More than one sexual partner in the last 6 months.
18 Years
60 Years
ALL
Yes
Sponsors
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Immuno-US
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Belshe R
Role: STUDY_CHAIR
Locations
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St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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10543
Identifier Type: REGISTRY
Identifier Source: secondary_id
AVEG 004
Identifier Type: -
Identifier Source: org_study_id