A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
NCT ID: NCT00000956
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
25 participants
INTERVENTIONAL
1993-03-31
Brief Summary
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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.
Detailed Description
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In the initial phase of the study, 20 healthy volunteers receive 640 mcg gp160 vaccine and 5 healthy volunteers receive alum placebo. At least 30 days later, 20 additional volunteers receive 1280 mcg gp160 vaccine and 5 volunteers receive placebo. Injections are given on days 0, 30, 180, and 365.
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 (MicroGeneSys)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
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.
18 Years
50 Years
ALL
Yes
Sponsors
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Protein Sciences Corporation
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
Clements ML
Role: STUDY_CHAIR
Couch R
Role: STUDY_CHAIR
Dolin R
Role: STUDY_CHAIR
Levine M
Role: STUDY_CHAIR
Wright P
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
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.
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.
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.
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.
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.
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.
Other Identifiers
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10542
Identifier Type: REGISTRY
Identifier Source: secondary_id
AVEG 003B
Identifier Type: -
Identifier Source: org_study_id