Nctid:
NCT00000832
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-16"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D000012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D000016180", "term"=>"Lentivirus Infections"}, {"id"=>"D000012192", "term"=>"Retroviridae Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D000007154", "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"=>{"browseLeaves"=>[{"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}, {"id"=>"M35911", "name"=>"MF59 oil emulsion", "relevance"=>"LOW"}, {"id"=>"M3628", "name"=>"Adjuvants, Immunologic", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"PREVENTION"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>30}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1998-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "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", "HIV-1", "Adjuvants, Immunologic", "HIV Envelope Protein gp120", "AIDS Vaccines", "HIV Seronegativity", "HIV Preventive Vaccine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Corey L, Weinhold K, Montefiori D, Stablein D. CTL and neutralizing antibody responses with a combination HIV-1 vaccine regimen. Int Conf AIDS. 1998;12:636 (abstract no 33221)"}, {"pmid"=>"7963729", "type"=>"BACKGROUND", "citation"=>"Kahn JO, Sinangil F, Baenziger J, Murcar N, Wynne D, Coleman RL, Steimer KS, Dekker CL, Chernoff D. Clinical and immunologic responses to human immunodeficiency virus (HIV) type 1SF2 gp120 subunit vaccine combined with MF59 adjuvant with or without muramyl tripeptide dipalmitoyl phosphatidylethanolamine in non-HIV-infected human volunteers. J Infect Dis. 1994 Nov;170(5):1288-91. doi: 10.1093/infdis/170.5.1288."}]}, "descriptionModule"=>{"briefSummary"=>"To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant emulsion versus MF59 alone in HIV-negative volunteers.\n\nOne approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.", "detailedDescription"=>"One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.\n\nHealthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0, 1, 6, 9, 10 and 12 (was months 0, 1, 6 and 10, amended 12/19/96)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria\n\nVolunteers must have:\n\n* Normal history and physical exam.\n* HIV negativity.\n* Absolute CD4 count \\>= 400 cells/mm3.\n* Normal urine dipstick with esterase and nitrite.\n* Lower risk sexual behavior.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nSubjects with the following symptoms or conditions are excluded:\n\n* Positive hepatitis B surface antigen.\n* Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.\n* Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (\\> 6 months) treated infection are eligible.\n* Active tuberculosis. NOTE: Subjects with a positive PPD and a 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, chronic illness, autoimmune disease, or use of immunosuppressive medications.\n* History of anaphylaxis or other serious adverse reactions to vaccines.\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 killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.\n* Experimental agents within 30 days prior to study entry.\n* Prior HIV vaccines.\n\nPrior Treatment:\n\nExcluded:\n\n* Blood products or immunoglobulin within the past 6 months.\n\nIdentifiable high-risk behavior for HIV infection, including:\n\n* History of injection drug use within past 12 months.\n* Higher risk sexual behavior."}, "identificationModule"=>{"nctId"=>"NCT00000832", "briefTitle"=>"A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers", "orgStudyIdInfo"=>{"id"=>"AVEG 024"}, "secondaryIdInfos"=>[{"id"=>"10575", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"MF59", "type"=>"BIOLOGICAL"}, {"name"=>"rgp120/HIV-1 SF-2", "type"=>"BIOLOGICAL"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"UAB AVEG", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"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}}, {"city"=>"Pittsburgh", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"JHU AVEG", "geoPoint"=>{"lat"=>40.44062, "lon"=>-79.99589}}], "overallOfficials"=>[{"name"=>"Corey L", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
