Nctid:
NCT00001043
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}, {"id"=>"D014615", "term"=>"Vaccinia"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D016180", "term"=>"Lentivirus Infections"}, {"id"=>"D012192", "term"=>"Retroviridae Infections"}, {"id"=>"D012327", "term"=>"RNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}, {"id"=>"D011213", "term"=>"Poxviridae Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"Human Immunodeficiency Virus", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"Human Immunodeficiency Virus", "relevance"=>"HIGH"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M17363", "name"=>"Vaccinia", "asFound"=>"Vaccinia", "relevance"=>"HIGH"}, {"id"=>"M15702", "name"=>"Smallpox", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M18640", "name"=>"Lentivirus Infections", "relevance"=>"LOW"}, {"id"=>"M15026", "name"=>"Retroviridae Infections", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M15700", "name"=>"Slow Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M14094", "name"=>"Poxviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"T5275", "name"=>"Smallpox", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}, {"id"=>"M340819", "name"=>"polysaccharide-K", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"PREVENTION"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>20}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1997-05", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-04", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Vaccines, Synthetic", "Vaccinia Virus", "Viral Vaccines", "Smallpox Vaccine", "HIV-1", "HIV Envelope Protein gp160", "AIDS Vaccines", "HIV Seronegativity", "HIV Preventive Vaccine"], "conditions"=>["HIV Infections", "HIV Seronegativity"]}, "referencesModule"=>{"references"=>[{"pmid"=>"10029244", "type"=>"BACKGROUND", "citation"=>"Gorse GJ, Corey L, Patel GB, Mandava M, Hsieh RH, Matthews TJ, Walker MC, McElrath MJ, Berman PW, Eibl MM, Belshe RB. HIV-1MN recombinant glycoprotein 160 vaccine-induced cellular and humoral immunity boosted by HIV-1MN recombinant glycoprotein 120 vaccine. National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1999 Jan 20;15(2):115-32. doi: 10.1089/088922299311547."}, {"type"=>"BACKGROUND", "citation"=>"Gorse GJ, McElrath MJ, Belshe RB, Corey L, Matthews T, Eibl M, Kennedy D, Frey S, Hsieh R, Walker MC. High dose HIV-1 MN recombinant gp160 (rgp160) vaccine induces anti-v3 MN, and IgG1-4 and IgA anti-rgp160 antibodies. Int Conf AIDS. 1996 Jul 7-12;11(1):7 (abstract no MoA153)"}]}, "descriptionModule"=>{"briefSummary"=>"AMENDED 8/94: To expand the safety and immunogenicity profile of MN rgp160 vaccine (Immuno-AG) by administering a higher dose (800 mcg) at 0, 1, 6, and 12 months and 0, 2, 8 and 14 months (these two schedules were compared in VEU 013A using a dose of 200 mcg). To obtain plasma following the fourth immunization. To evaluate skin test reactivity.\n\nORIGINAL (replaced): To determine in healthy volunteers the safety and immunogenicity of two immunizations of MN rgp160 vaccine (Immuno-AG) in combination with a live recombinant vaccinia virus LAV HIV-1 gp160 vaccine (HIVAC-1e) versus DryVax (the standard smallpox vaccine that was used for many years) control in combination with placebo.\n\nORIGINAL (replaced): A gp160 vaccine derived from the MN strain, the most prevalent strain of HIV-1 in the United States, has been developed. A previous study showed that a combination vaccine strategy, consisting of priming with HIVAC-1e followed by boosting with a gp160 subunit vaccine, resulted in humoral and cellular immune responses of greater and longer duration than either vaccine alone. Thus, a live vector/subunit boost approach using the MN rgp160 vaccine merits investigation.", "detailedDescription"=>"ORIGINAL (replaced): A gp160 vaccine derived from the MN strain, the most prevalent strain of HIV-1 in the United States, has been developed. A previous study showed that a combination vaccine strategy, consisting of priming with HIVAC-1e followed by boosting with a gp160 subunit vaccine, resulted in humoral and cellular immune responses of greater and longer duration than either vaccine alone. Thus, a live vector/subunit boost approach using the MN rgp160 vaccine merits investigation.\n\nAMENDED 8/94: Volunteers are randomized to receive 800 mcg MN rgp160 vaccine (Immuno-AG) or adjuvant control (placebo) on one of two dosing schedules. Sixteen volunteers receive candidate vaccine and four volunteers receive placebo.\n\nORIGINAL (replaced): Volunteers are randomized to receive either HIVAC-1e on days 0 and 56 followed by immunization with MN rgp160 vaccine on days 224 and 364, or DryVax control on days 0 and 56 followed by placebo on days 224 and 364. Ten volunteers are entered on the MN rgp160 vaccine arm and two volunteers on the placebo arm.\n\nPER AMENDMENT 7/96: Two additional booster immunizations of 600 mcg of MN rgp 120/HIV-1 vaccine given at study months 22 and 24 to consenting St. Louis University volunteers."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria\n\nSubjects must have:\n\n* Normal history and physical exam.\n* Negative test for HIV by ELISA within 6 weeks prior to immunization.\n* Negative test for HIV by Western blot.\n* CD4 count \\>= 400 cells/mm3.\n* No history of smallpox vaccination.\n* Normal urine dipstick with esterase and nitrate.\n* No history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppresssive medications.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nSubjects with the following conditions are excluded:\n\n* Positive for hepatitis B surface antigen.\n* Medical or psychiatric condition or occupational responsibilities that preclude compliance.\n* Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (\\> 6 months) infection, subject is eligible).\n* Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible).\n* Eczema.\n\nHousehold contact with persons meeting any of the following criteria:\n\n* pregnancy, \\< 12 months of age, eczema, or immunodeficiency disease or use of immunosuppressive medications.\n\nSubjects with the following prior conditions are excluded:\n\n* History of anaphylaxis or other serious adverse reactions to vaccines.\n* Eczema within the past year.\n* PER 8/94 AMENDMENT: History of cancer unless surgically excised with reasonable assurance of cure.\n* PER 8/94 AMENDMENT: History of serious allergic reaction requiring hospitalization or emergent medical care.\n\nPrior Medication:\n\nExcluded:\n\n* Prior HIV vaccines.\n* Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations.\n* Experimental agents within the past 30 days.\n\nPrior Treatment:\n\nExcluded:\n\n* Blood products or immunoglobulin within the past 6 months.\n\nHigher risk behavior for HIV infection as determined by screening questionnaire, including:\n\n* History of injection drug use within 12 months prior to study entry.\n* Higher or intermediate risk sexual behavior."}, "identificationModule"=>{"nctId"=>"NCT00001043", "briefTitle"=>"A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules", "orgStudyIdInfo"=>{"id"=>"AVEG 013B"}, "secondaryIdInfos"=>[{"id"=>"10560", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"gp160 Vaccine (Immuno-AG)", "type"=>"BIOLOGICAL"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"63104", "city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"St. Louis Univ. School of Medicine AVEG", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"98144", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"UW - Seattle AVEG", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}], "overallOfficials"=>[{"name"=>"Gorse G", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
