Nctid:
NCT00000746
Payload:
{"FullStudy"=>{"Rank"=>474866, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000014615", "ConditionMeshTerm"=>"Vaccinia"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000011213", "ConditionAncestorTerm"=>"Poxviridae Infections"}, {"ConditionAncestorId"=>"D000004266", "ConditionAncestorTerm"=>"DNA Virus Infections"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17212", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17940", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17053", "ConditionBrowseLeafName"=>"Vaccinia", "ConditionBrowseLeafAsFound"=>"Vaccinia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M13784", "ConditionBrowseLeafName"=>"Poxviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7132", "ConditionBrowseLeafName"=>"DNA Virus Infections", "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"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M17050", "InterventionBrowseLeafName"=>"Vaccines", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Prevention"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"56"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"July 1994", "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", "Vaccinia Virus", "Viral Vaccines", "HIV-1", "HIV Envelope Protein gp160", "HIV Envelope Protein gp120", "AIDS Vaccines", "HIV Seronegativity", "HIV Preventive Vaccine"]}, "ConditionList"=>{"Condition"=>["HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"Clements ML, Corey L, Weinhold K, Schwartz D, Siliciano R, Matthews T, Hsieh R, Graham B, Keefer M, Gorse G, Zolla-Pazner S, Mascola J, Duliege A, Excler J, Tartaglia J, Paoletti E, Hu SL. HIV immunity induced by priming with canarypox or vaccinia-gp160 recombinants and boosting with rgp120. Inst of Hum Virol Annu Meet. 1996 Sept 7-13"}, {"ReferencePMID"=>"1353102", "ReferenceType"=>"background", "ReferenceCitation"=>"Graham BS, Belshe RB, Clements ML, Dolin R, Corey L, Wright PF, Gorse GJ, Midthun K, Keefer MC, Roberts NJ Jr, et al. Vaccination of vaccinia-naive adults with human immunodeficiency virus type 1 gp160 recombinant vaccinia virus in a blinded, controlled, randomized clinical trial. The AIDS Vaccine Clinical Trials Network. J Infect Dis. 1992 Aug;166(2):244-52. doi: 10.1093/infdis/166.2.244."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity of the three subunit vaccines when administered as boosters.\n\nSecondary: To examine the safety of administering the individual subunit vaccines in combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone.\n\nIn a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone.", "DetailedDescription"=>"In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone.\n\nSeventy healthy volunteers are randomized to one of four groups. Groups A and D receive one initial immunization with HIVAC-1e followed by two boosts with subunit gp120 and Env 2-3, respectively, at months 8 and 12. Group B receives two immunizations with HIVAC-1e at months 0 and 8 followed by a single boost with subunit gp120 at month 12. Group C receives three doses of subunit gp120 only at months 0, 8 and 12. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) have been eliminated.) Subjects are followed for 18 months."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"60 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Inclusion Criteria\n\nSubjects must have:\n\nNormal history and physical exam.\nNegative HIV screening by ELISA, Western blot, and p24 antigen (PBMC HIV culture or HIV-specific PCR can be substituted for Western blot and p24 antigen).\nHistory of smallpox vaccination more than 5 years prior to enrollment.\nNormal urinalysis.\nAbsolute CD4 count = or > 500 cells/mm3.\n\nPrior Medication: Required:\n\nVaccinia (smallpox) vaccination more than 5 years prior to study enrollment. Identifiable high-risk behavior for HIV infection as determined by screening questionnaire/interview.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nSubjects with the following symptoms or conditions are excluded:\n\nHousehold contacts who are pregnant, < 12 months of age, have eczema, or have immunodeficiency disease or who use immunosuppressive medications.\nHepatitis B surface antigenemia.\nMedical or psychiatric condition or occupational responsibilities that preclude compliance.\n\nSubjects with the following prior conditions are excluded:\n\nHistory of immunodeficiency or chronic illness.\nEczema within the past year.\n\nPrior Medication:\n\nExcluded:\n\nPrior experimental HIV vaccine.\nImmunoglobulin administration or use of experimental agent within the past 2 months.\nHistory of immunosuppressive medications.\n\nPrior Treatment:\n\nExcluded:\n\nBlood or blood product transfusion within the previous 6 months."}, "IdentificationModule"=>{"NCTId"=>"NCT00000746", "BriefTitle"=>"A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines", "OrgStudyIdInfo"=>{"OrgStudyId"=>"AVEG 008"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"AVEG Protocol 008"}, {"SecondaryId"=>"10553", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"rgp120/HIV-1 SF-2", "InterventionType"=>"Biological"}, {"InterventionName"=>"Env 2-3", "InterventionType"=>"Biological"}, {"InterventionName"=>"HIVAC-1e", "InterventionType"=>"Biological"}, {"InterventionName"=>"gp160 Vaccine (MicroGeneSys)", "InterventionType"=>"Biological"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationCity"=>"Pittsburgh", "LocationState"=>"Pennsylvania", "LocationCountry"=>"United States", "LocationFacility"=>"JHU AVEG"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Corey L", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
