Nctid:
NCT00000904
Payload:
{"FullStudy"=>{"Rank"=>498427, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000015658", "ConditionMeshTerm"=>"HIV Infections"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000086982", "ConditionAncestorTerm"=>"Blood-Borne Infections"}, {"ConditionAncestorId"=>"D000003141", "ConditionAncestorTerm"=>"Communicable Diseases"}, {"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000015229", "ConditionAncestorTerm"=>"Sexually Transmitted Diseases, Viral"}, {"ConditionAncestorId"=>"D000012749", "ConditionAncestorTerm"=>"Sexually Transmitted Diseases"}, {"ConditionAncestorId"=>"D000016180", "ConditionAncestorTerm"=>"Lentivirus Infections"}, {"ConditionAncestorId"=>"D000012192", "ConditionAncestorTerm"=>"Retroviridae Infections"}, {"ConditionAncestorId"=>"D000012327", "ConditionAncestorTerm"=>"RNA Virus Infections"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000091662", "ConditionAncestorTerm"=>"Genital Diseases"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000007153", "ConditionAncestorTerm"=>"Immunologic Deficiency Syndromes"}, {"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3522", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18250", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafAsFound"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M2593", "ConditionBrowseLeafName"=>"Blood-Borne Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15558", "ConditionBrowseLeafName"=>"Sexually Transmitted Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17933", "ConditionBrowseLeafName"=>"Sexually Transmitted Diseases, Viral", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18640", "ConditionBrowseLeafName"=>"Lentivirus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15026", "ConditionBrowseLeafName"=>"Retroviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17522", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15149", "ConditionBrowseLeafName"=>"RNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Genital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2875", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M16355", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10199", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10200", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"C000010770", "InterventionMeshTerm"=>"polysaccharide-K"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000276", "InterventionAncestorTerm"=>"Adjuvants, Immunologic"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000000903", "InterventionAncestorTerm"=>"Antibiotics, Antineoplastic"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000000998", "InterventionAncestorTerm"=>"Antiviral Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000007369", "InterventionAncestorTerm"=>"Interferon Inducers"}, {"InterventionAncestorId"=>"D000011837", "InterventionAncestorTerm"=>"Radiation-Protective Agents"}, {"InterventionAncestorId"=>"D000020011", "InterventionAncestorTerm"=>"Protective Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M10184", "InterventionBrowseLeafName"=>"Immunoglobulins", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4225", "InterventionBrowseLeafName"=>"Antibodies", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17360", "InterventionBrowseLeafName"=>"Vaccines", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M18138", "InterventionBrowseLeafName"=>"HIV Antibodies", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M340819", "InterventionBrowseLeafName"=>"polysaccharide-K", "InterventionBrowseLeafAsFound"=>"Uniform", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3628", "InterventionBrowseLeafName"=>"Adjuvants, Immunologic", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10201", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4222", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4224", "InterventionBrowseLeafName"=>"Antibiotics, Antitubercular", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4314", "InterventionBrowseLeafName"=>"Antiviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4214", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10407", "InterventionBrowseLeafName"=>"Interferons", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21869", "InterventionBrowseLeafName"=>"Protective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14684", "InterventionBrowseLeafName"=>"Radiation-Protective Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Prevention"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"100"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"August 1999", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 27, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 4, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Vaccines, Synthetic", "Viral Vaccines", "HIV Antibodies", "HIV Envelope Protein gp160", "AIDS Vaccines", "T-Lymphocytes, Cytotoxic", "HIV Seronegativity", "Antibody Formation", "Risk-Taking", "Avipoxvirus", "Genetic Vectors", "Immunization", "HIV Preventive Vaccine"]}, "ConditionList"=>{"Condition"=>["HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"Fang ZY, Limbach K, Tartaglia J, Spearman P. A canarypox HIV vaccine candidate elicits efficient gag-env pseudovirion formation from human muscle cells. 36th Annual Meeting, Infectious Diseases Society of America. 1998 Nov 12-15 [Poster 710]"}, {"ReferencePMID"=>"11153085", "ReferenceType"=>"background", "ReferenceCitation"=>"Bures R, Gaitan A, Zhu T, Graziosi C, McGrath KM, Tartaglia J, Caudrelier P, El Habib R, Klein M, Lazzarin A, Stablein DM, Deers M, Corey L, Greenberg ML, Schwartz DH, Montefiori DC. Immunization with recombinant canarypox vectors expressing membrane-anchored glycoprotein 120 followed by glycoprotein 160 boosting fails to generate antibodies that neutralize R5 primary isolates of human immunodeficiency virus type 1. AIDS Res Hum Retroviruses. 2000 Dec 10;16(18):2019-35. doi: 10.1089/088922200750054756."}]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to find out whether three different anti-HIV vaccines are safe and whether they help prevent HIV infection. These vaccines are called vCP205, vCP1433, and vCP1452. Some patients also receive another anti-HIV vaccine, gp160. The vaccines are made up of small pieces of HIV, which help the body learn to recognize and destroy HIV. You cannot get HIV from these vaccines.\n\nThere are two different ways a vaccine can protect the body from infection. First, a vaccine may help the immune system make antibodies, which are proteins that recognize invading viruses or bacteria. Second, a vaccine may help the body make immune cells that destroy infected cells. The second type of vaccine is more powerful against HIV. In this study, doctors will see whether vCP205, vCP1433, vCP1452, and gp160 are good vaccines by seeing whether they help the body make immune cells.", "DetailedDescription"=>"Previous studies in humans have shown that immunization with certain vaccine combinations (that is, ALVAC-HIV construct and an envelope subunit vaccine) can elicit CTL activity, antibody-dependent cellular toxicity (ADCC), neutralizing antibodies, and other antibody responses more often and at higher levels than either vaccine alone. This study examines improved vaccine candidates that can elicit broader, longer-lasting CTL activity in the majority of vaccine recipients.\n\nVolunteers are randomized to one of four groups. Group I receives vCP205. Group II receives vCP1433. Group III receives vCP1452. Group IV receives an ALVAC rabies vaccine, as a control. Immunizations are administered at Months 0, 1, 3, and 6. At Months 3 and 6, patients in Groups I, II, and III also receive gp160 MN/LAI-2, the subunit boost vaccine. Group IV receives another placebo vaccine. Participants have regular clinic visits and blood is drawn to determine humoral and cellular immune responses to the vaccines. [AS PER AMENDMENT 10/23/98: A cell-mediated immunity substudy has been added at selected institutions following the fourth vaccination at 6 months; this study will assess the newer assays of CD8+ T cells and the kinetic response following immunization. The 6-month immunization may be rescheduled by up to 14 days to accommodate clinical, laboratory, or volunteer scheduling issues.] [AS PER AMENDMENT 6/17/99: Three study arms are added. Group V receives vCP1452 at Months 0,1,3, and 6. Group VI receives vCP205 at Months 0,1,3, and 6. Group VII receives placebo at Months 0,1,3, and 6. Patients in Groups V, VI, and VII do not receive the subunit boost, gp160 MN/LAI-2. Consenting volunteers enrolled in the three new groups at Johns Hopkins University undergo PET scanning as part of an ancillary study.]"}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"60 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Inclusion Criteria\n\nYou may be eligible for this study if you:\n\nAre 18-60 years old.\nAre HIV-negative and are in good health.\nHave a CD4 count of at least 400 cells/mm3.\nTest negative for hepatitis B.\nAgree to use effective methods of birth control for 1 month before and during the study.\n\nExclusion Criteria\n\nYou will not be eligible for this study if you:\n\nAre at high risk for being infected with HIV (risky sex behavior or injection drug use within 12 months prior to study entry).\nHave a serious medical condition, or if you have had chronic sickness, diseases of the immune system, or cancer that was not cured through surgery.\nHave a serious psychiatric condition or if you have been suicidal.\nHave a work commitment that would keep you from completing the study.\nHave syphilis or tuberculosis.\nAre allergic to eggs, neomycin, vaccines, or have ever had severe allergic reactions.\nHave taken certain medicines, including medicines that affect the immune system or experimental medicines.\nHave participated in another HIV vaccine trial.\nHave received any vaccines within 2 weeks of study entry.\nHave received a blood transfusion within 6 months prior to study entry.\nAre pregnant or breast-feeding."}, "IdentificationModule"=>{"NCTId"=>"NCT00000904", "BriefTitle"=>"Safety and Effectiveness of Anti-HIV Vaccines in HIV-Negative Adults", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Phase I Trial to Compare the Safety and Immunogenicity of the Live Recombinant Canarypox ALVAC-HIV Vaccines, vCP205, vCP1433, and vCP1452, in HIV-1 Uninfected Adult Volunteers", "OrgStudyIdInfo"=>{"OrgStudyId"=>"AVEG 034"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"AVEG 034A"}, {"SecondaryId"=>"10583", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"ALVAC(2)120(B,MN)GNP (vCP1452)", "InterventionType"=>"Biological"}, {"InterventionName"=>"gp160 MN/LAI-2", "InterventionType"=>"Biological"}, {"InterventionName"=>"ALVAC(1)120(B,MN)GNP (vCP1433)", "InterventionType"=>"Biological"}, {"InterventionName"=>"ALVAC-HIV MN120TMG (vCP205)", "InterventionType"=>"Biological"}, {"InterventionName"=>"ALVAC-RG Rabies Glycoprotein (vCP65)", "InterventionType"=>"Biological"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"35294", "LocationCity"=>"Birmingham", "LocationState"=>"Alabama", "LocationCountry"=>"United States", "LocationFacility"=>"UAB AVEG"}, {"LocationZip"=>"21205", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"JHU AVEG"}, {"LocationZip"=>"63110", "LocationCity"=>"Saint Louis", "LocationState"=>"Missouri", "LocationCountry"=>"United States", "LocationFacility"=>"St. Louis Univ. School of Medicine AVEG"}, {"LocationZip"=>"14642", "LocationCity"=>"Rochester", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Univ. of Rochester AVEG"}, {"LocationZip"=>"37232", "LocationCity"=>"Nashville", "LocationState"=>"Tennessee", "LocationCountry"=>"United States", "LocationFacility"=>"Vanderbilt Univ. Hosp. AVEG"}, {"LocationZip"=>"98104", "LocationCity"=>"Seattle", "LocationState"=>"Washington", "LocationCountry"=>"United States", "LocationFacility"=>"UW - Seattle AVEG"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"David Schwartz", "OverallOfficialRole"=>"Study Chair", "OverallOfficialAffiliation"=>"Johns Hopkins Bloomberg School of Public Health"}, {"OverallOfficialName"=>"Clayton Harro", "OverallOfficialRole"=>"Study Chair", "OverallOfficialAffiliation"=>"Johns Hopkins Bloomberg School of Public Health"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
