Nctid:
NCT00001052
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-28"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}], "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"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency 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"=>"M17522", "name"=>"Virus Diseases", "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"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "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"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000536", "term"=>"Aluminum Hydroxide"}], "ancestors"=>[{"id"=>"D000276", "term"=>"Adjuvants, Immunologic"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000863", "term"=>"Antacids"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D005765", "term"=>"Gastrointestinal Agents"}], "browseLeaves"=>[{"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}, {"id"=>"M3877", "name"=>"Aluminum Hydroxide", "asFound"=>"Tight", "relevance"=>"HIGH"}, {"id"=>"M3628", "name"=>"Adjuvants, Immunologic", "relevance"=>"LOW"}, {"id"=>"M257732", "name"=>"Aluminum sulfate", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M4188", "name"=>"Antacids", "relevance"=>"LOW"}, {"id"=>"M4219", "name"=>"Anti-Ulcer Agents", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"PREVENTION"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>110}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1997-09", "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", "Drug Therapy, Combination", "Adjuvants, Immunologic", "HIV Envelope Protein gp120", "AIDS Vaccines", "HIV Seronegativity", "HIV Preventive Vaccine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9086128", "type"=>"BACKGROUND", "citation"=>"Zolla-Pazner S, Alving C, Belshe R, Berman P, Burda S, Chigurupati P, Clements ML, Duliege AM, Excler JL, Hioe C, Kahn J, McElrath MJ, Sharpe S, Sinangil F, Steimer K, Walker MC, Wassef N, Xu S. Neutralization of a clade B primary isolate by sera from human immunodeficiency virus-uninfected recipients of candidate AIDS vaccines. J Infect Dis. 1997 Apr;175(4):764-74. doi: 10.1086/513969."}, {"pmid"=>"11228380", "type"=>"BACKGROUND", "citation"=>"Evans TG, McElrath MJ, Matthews T, Montefiori D, Weinhold K, Wolff M, Keefer MC, Kallas EG, Corey L, Gorse GJ, Belshe R, Graham BS, Spearman PW, Schwartz D, Mulligan MJ, Goepfert P, Fast P, Berman P, Powell M, Francis D; NIAID AIDS Vaccine Evaluation Group. QS-21 promotes an adjuvant effect allowing for reduced antigen dose during HIV-1 envelope subunit immunization in humans. Vaccine. 2001 Feb 28;19(15-16):2080-91. doi: 10.1016/s0264-410x(00)00415-1."}]}, "descriptionModule"=>{"briefSummary"=>"To extend the evaluation of safety and immunogenicity of MN recombinant soluble gp120/HIV-1 (MN rsgp120/HIV-1) in combination with QS21 with or without alum and on two different vaccination schedules.\n\nRecent animal studies indicate that immunizing with MN rsgp120/HIV-1 in combination with QS21 on a 0, 1, 2 month schedule results in a more rapid rise in binding and neutralizing antibody response than on a 0, 1, 6 month schedule. Such an effect may be particularly desirable in vaccine delivery. This study compares these two delivery schedules using the unadjuvanted vaccine formulation rsgp120/HIV-1 with or without addition of alum.", "detailedDescription"=>"Recent animal studies indicate that immunizing with MN rsgp120/HIV-1 in combination with QS21 on a 0, 1, 2 month schedule results in a more rapid rise in binding and neutralizing antibody response than on a 0, 1, 6 month schedule. Such an effect may be particularly desirable in vaccine delivery. This study compares these two delivery schedules using the unadjuvanted vaccine formulation rsgp120/HIV-1 with or without addition of alum.\n\nHealthy volunteers (20 per group) receive MN rsgp120/HIV-1 (300 or 0 mcg) in combination with QS21 (100 mcg), either with or without alum, at 0, 1, and 2 months or 0, 1, and 6 months. For both vaccination schedules, an additional five volunteers receive only vehicle with alum. The 0 mcg antigen groups are included primarily as negative controls. Subjects may be contacted for follow-up on health status once or twice yearly for at least 5 years."}, "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* HIV negative by ELISA within 8 weeks of immunization.\n* Absolute CD4 count \\>= 400 cells/mm3.\n* Normal urine dipstick with esterase and nitrite.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nSubjects with the following symptoms or conditions are excluded:\n\n* Hepatitis B surface antigen.\n* Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.\n* Occupational responsibilities that preclude compliance.\n* Active syphilis. NOTE: Subjects with serology documented to be false positive or due to a remote (\\> 6 months) treated infection are eligible.\n* Active tuberculosis. NOTE: Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.\n\nSubjects with the following prior conditions are excluded:\n\n* History of immunodeficiency, autoimmune disease, or use of immunosuppressive medications.\n* History of anaphylaxis or other serious adverse reactions to vaccines.\n* History of allergy to thimerosal.\n* History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).\n* Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.\n* History of cancer unless there has been surgical excision that is considered to have achieved cure.\n\nPrior Medication:\n\nExcluded:\n\n* Live attenuated vaccines within 60 days prior to study entry. (NOTE: Medically indicated subunit or killed vaccines, such as influenza or pneumococcal, are allowed but should be given at least 2 weeks prior to HIV immunizations.)\n* Experimental agents within 30 days prior to study entry.\n* Prior HIV vaccines.\n\nPrior Treatment:\n\nExcluded:\n\n* Receipt of blood products or immunoglobulin within the past 6 months.\n\nRisk Behavior:\n\n* Subjects are NOT excluded on the basis of HIV risk behaviors, but AVOIDANCE of any activity that may expose subject to HIV (e.g., unprotected sex or needle sharing) is STRONGLY RECOMMENDED."}, "identificationModule"=>{"nctId"=>"NCT00001052", "briefTitle"=>"A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults", "orgStudyIdInfo"=>{"id"=>"AVEG 016A"}, "secondaryIdInfos"=>[{"id"=>"10565", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Aluminum hydroxide", "type"=>"BIOLOGICAL"}, {"name"=>"QS-21", "type"=>"BIOLOGICAL"}, {"name"=>"rgp120/HIV-1MN", "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"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ. of Rochester AVEG", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"15261", "city"=>"Pittsburgh", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"JHU AVEG", "geoPoint"=>{"lat"=>40.44062, "lon"=>-79.99589}}, {"zip"=>"37232", "city"=>"Nashville", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Vanderbilt Univ. Hosp. AVEG", "geoPoint"=>{"lat"=>36.16589, "lon"=>-86.78444}}, {"zip"=>"98144", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"UW - Seattle AVEG", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}], "overallOfficials"=>[{"name"=>"McElrath J", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}