A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
NCT ID: NCT00000632
Last Updated: 2021-11-02
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
14 participants
INTERVENTIONAL
1992-05-31
Brief Summary
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Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.
Detailed Description
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Twelve healthy volunteers receive injections of 100 mcg Env 2-3 in MF59 emulsion and two volunteers receive MF59 only on days 0, 30, 180, and 365. Follow-up continues for 6 months after the last injection.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PREVENTION
Interventions
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Env 2-3
Eligibility Criteria
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Inclusion Criteria
* Normal, healthy adults (by history and physical examination) who fully comprehend the purpose and details of the study.
Exclusion Criteria
Subjects with the following conditions or symptoms are excluded:
* Positive syphilis serology (such as VDRL) unless positive test is due to a documented clinical event that occurred and was treated 5 or more years prior to enrollment.
* Circulating hepatitis B antigenemia.
Subjects with the following prior conditions are excluded:
* History of immunodeficiency, chronic illness, or autoimmune disease.
* 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.
Identifiable high-risk behavior for HIV infection, including:
* history of intravenous drug use; syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the last 6 months; more than two sexual partners, or sexual contact with a high-risk partner, in the preceding 6 months.
18 Years
50 Years
ALL
Yes
Sponsors
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Biocine
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Dolin R
Role: STUDY_CHAIR
Locations
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Univ. of Rochester AVEG
Rochester, New York, United States
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States
UW - Seattle AVEG
Seattle, Washington, United States
Countries
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References
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Evans TG, Fitzgerald T, Gibbons DC, Keefer MC, Soucier H. Th1/Th2 cytokine responses following HIV-1 immunization in seronegative volunteers. The AIDS Vaccine Evaluation Group. Clin Exp Immunol. 1998 Feb;111(2):243-50. doi: 10.1046/j.1365-2249.1998.00486.x.
Keefer MC, Graham BS, McElrath MJ, Matthews TJ, Stablein DM, Corey L, Wright PF, Lawrence D, Fast PE, Weinhold K, Hsieh RH, Chernoff D, Dekker C, Dolin R. Safety and immunogenicity of Env 2-3, a human immunodeficiency virus type 1 candidate vaccine, in combination with a novel adjuvant, MTP-PE/MF59. NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1996 May 20;12(8):683-93. doi: 10.1089/aid.1996.12.683.
Other Identifiers
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10548
Identifier Type: REGISTRY
Identifier Source: secondary_id
AVEG 005C
Identifier Type: -
Identifier Source: org_study_id