A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of Accelerated Schedules
NCT ID: NCT00000957
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
30 participants
INTERVENTIONAL
1993-08-31
Brief Summary
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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.
Detailed Description
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Thirty healthy adult volunteers without identifiable high-risk behavior for HIV-1 are randomly assigned to receive vaccination with gp160 (50 mcg) according to one of the following schedules: Group 1 receives vaccine on days 0, 28, 56, and 140 and placebo on days 84 and 112; Group 2 receives vaccine on days 0, 28, 56, 84, and 112 and placebo on day 140. Subjects are followed for 1 year after the last injection. Per 05/13/94 amendment, 10 subjects at the St. Louis University site receive an additional boost 18-24 months after the last injection.
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:
* They or their sexual partners have identifiable high-risk behavior for HIV infection.
* Positive syphilis serology (e.g., VDRL).
* Positive for circulating hepatitis B antigen.
Patients with the following prior conditions are excluded:
* History of positive PPD (tuberculin test).
* 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.
* Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 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
JHU AVEG
Pittsburgh, Pennsylvania, United States
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, 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.
Gorse GJ, Schwartz DH, Graham BS, Matthews TJ, Stablein DM, Frey SE, Belshe RB, Clements ML, Wright PF, Eibl M, et al. HIV-1 recombinant gp160 vaccine given in accelerated dose schedules. NIAID AIDS Vaccine Clinical Trials Network. Clin Exp Immunol. 1994 Nov;98(2):178-84. doi: 10.1111/j.1365-2249.1994.tb06122.x.
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.
Other Identifiers
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10545
Identifier Type: REGISTRY
Identifier Source: secondary_id
AVEG 004B
Identifier Type: -
Identifier Source: org_study_id