{
  "FullStudy":{
    "Rank":218096,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512784",
          "OrgStudyIdInfo":{
            "OrgStudyId":"HLS04/2011"
          },
          "Organization":{
            "OrgFullName":"University of Milan",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults",
          "OfficialTitle":"Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults vs. Healthy Adolescents and Young Adults: Non-randomized Controlled Clinical Trial"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2013",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2013",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 18, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 19, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Gian Vincenzo Zuccotti",
            "ResponsiblePartyInvestigatorTitle":"Long term Immunogenicity of Quadrivalent Human Papillomavirus vaccine (Gardasil®) in HIV-infected adolescents and young adults vs. healthy adolescents and young adults: non-randomized controlled clinical trial",
            "ResponsiblePartyInvestigatorAffiliation":"University of Milan"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Milan",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV infection and the development of HPV-associated lesions in female and male anogenital tract. Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in HIV-infected population are few. The present study is a non-randomized controlled clinical trial with the primary objective to determine safety ad immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) in HIV-infected female and male adolescents and young adults."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "HPV",
              "HIV"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Quadrivalent Human Papillomavirus Vaccine (HPV) Gardasil",
              "HIV infection",
              "Evaluation of quadrivalent HPV vaccine in adolescents and young adults."
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"100",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"HIV-infected adolescents and young adults",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"female and male HIV-infected subjects aged from 13-27 years old",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Biological: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)"
                  ]
                }
              },{
                "ArmGroupLabel":"healthy adolescents and young adults",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"female and male healthy adolescents and young adults aged 13-27 years",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Biological: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Biological",
                "InterventionName":"Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)",
                "InterventionDescription":"Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed).\n\nEach dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule:\n\nFirst dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1.\n\nIngredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately:\n\nHuman Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "HIV-infected adolescents and young adults"
                  ]
                }
              },{
                "InterventionType":"Biological",
                "InterventionName":"Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)",
                "InterventionDescription":"Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed).\n\nEach dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule:\n\nfirst dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1.\n\nIngredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately:\n\nHuman Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "healthy adolescents and young adults"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"type specific antibody titers for HPV types 6, 11, 16 and 18 at one month after completion of HPV vaccine series (T3) in HIV infected subjects vs. healthy subjects",
                "PrimaryOutcomeDescription":"Immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) will be assessed by evaluation of type-specific antibody development for HPV types 6, 11, 16 and 18 from seronegative status at baseline (T0) to seropositive status at one month after the completion of HPV vaccine series (T3), compared with the same immunogenicity testings performed in healthy subjects matched for sex and age.",
                "PrimaryOutcomeTimeFrame":"one month +/- 10 days after 3° vaccine dose"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"antibody HPV titers to types 6, 11, 16 and 18, one month after the first two vaccination series (T1 and T2) in HIV-infected subjects vs healthy subjects",
                "SecondaryOutcomeDescription":"Antibody titers for HPV types 6, 11, 16 and 18 will be evaluated one month after the first (T1) and second (T2) vaccination dose in HIV-infected adolescents and young adults compared with the same immunological testings in healthy adolescents and young adults.",
                "SecondaryOutcomeTimeFrame":"one month +/- 10 days after 1°vaccine dose and month+/- 10 days after 2° vaccine dose"
              },{
                "SecondaryOutcomeMeasure":"antibody titers to HPV types 6, 11, 16 and 18 at month 12(T4)and 18 (T5)from baseline (T0).",
                "SecondaryOutcomeDescription":"To assess long-term immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil® in HIV-infected and healthy subjects by evaluation of persistence of HPV antibody titers to types 6, 11, 16 and 18 at month 12 (T4) and 18(T5) from baseline (T0).",
                "SecondaryOutcomeTimeFrame":"12 months +/- 10 days and 18 months +/-10 days from baseline"
              },{
                "SecondaryOutcomeMeasure":"local and systemic adverse events",
                "SecondaryOutcomeDescription":"Safety and tolerability of three doses of quadrivalent human papillomavirus vaccine (Gardasil ®) in HIV-infected and healthy subjects will be assessed by evaluating the occurrence and severity of local and systemic adverse events during the 7 days after each vaccination dose.",
                "SecondaryOutcomeTimeFrame":"7 days after each vaccination dose"
              },{
                "SecondaryOutcomeMeasure":"HIV viral load and lymphocyte CD4+ count",
                "SecondaryOutcomeDescription":"Longitudinal monitoring of HIV-viral load and lymphocyte CD4+ count will be conducted in HIV-infected subjects from baseline (T0), throughout the study: one month after each vaccination dose (T1, T2, T3) and at month 12 and 18 from baseline (T4, T5).",
                "SecondaryOutcomeTimeFrame":"baseline (T0), one month after each vaccination dose (T1, T2 and T3) and at month 12 (T4) and 18 (T5) from baseline."
              },{
                "SecondaryOutcomeMeasure":"lymphoproliferative responses, cytokine production and immunophenotype analysis of lymphocyte subpopulations",
                "SecondaryOutcomeDescription":"To evaluate in a subgroup of subjects (20 HIV-infected and 20 healthy) the following immunological parameters at baseline and at 1 month after 1° vaccination dose (T1) and at 1 month after 3° vaccination dose (T3):\n\nlymphoproliferative responses to HPV-16 L1 from PBMCs in peripheral blood\n\nImmunophenotype analysis of lymphocyte subpopulations in peripheral blood\n\nCytokine production from peripheral lymphocyte subpopulations at baseline and after stimulation with HPV-16 recombinant protein L1.",
                "SecondaryOutcomeTimeFrame":"baseline (T0), one month after 1° vaccination dose (T1) and one month after 3° vaccination dose (T3)."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFor both HIV-infected and healthy subjects:\n\nSubjects aged 13-27 years, females and males\nWritten informed consent from parent or guardian if applicable (age<18 years)\n\nFor HIV-infected subjects:\n\nHIV-positive\nAsymptomatic subjects (generalized lymphadenopathy is accepted)\nLymphocyte CD4+ count > or equal to 350 cells/mm3\n\nFor subjects receiving HAART:\n\nGood compliance to therapy\nAt least two suppressed viral loads HIV-RNA (<37copies/ml9 during 6 months prior to enrollment.\n\nExclusion Criteria:\n\nFor female subjects (both HIV-infected and healthy)\nPregnancy or breastfeeding\nTotal hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded.\nFor both females and males (HIV-infected and healthy):\nPrior vaccination with quadrivalent HPV vaccine Gardasil before study entry.\nHistory of severe allergic reaction after previous vaccination or hypersensitivity to any vaccine component.\nAny serious chronic or progressive disease (other than HIV) according to the judgment of the investigator:\nAcute infection requiring therapy or fever at time of enrollment\nChronic autoimmune or oncologic disease receiving chemotherapy\nConcomitant therapies (other than HAART):\nChronic therapy (for more than 14 days consecutively) with immunosuppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry.\nReceipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry.\nUse of investigational agents within 4 weeks prior to study enrollment.\nCurrent drug or alcohol use or dependence.\nDocumented history of non-adherence to antiretroviral treatment regimen within 12 months prior to study entry.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"13 Years",
          "MaximumAge":"27 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Gian Vincenzo Zuccotti, Head Paediatric Department",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"0039/02/39042253",
                "CentralContactEMail":"gianvincenzo.zuccotti@unimi.it"
              },{
                "CentralContactName":"Gian Vincenzo Zuccotti, Head Paediatrics",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"0039/02/39042253",
                "CentralContactEMail":"gianvincenzo.zuccotti@unimi.it"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Gian Vincenzo Zuccotti, Head of Paediatric Department",
                "OverallOfficialAffiliation":"L.Sacco Hospital, via G.B Grassi, 74 20157 Milano, Italy",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Luigi Sacco Hospital , Department of Paediatrics, via G.B Grassi, 74",
                "LocationStatus":"Recruiting",
                "LocationCity":"Milan",
                "LocationZip":"20157",
                "LocationCountry":"Italy",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Francesca Penagini, Doctor",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"0039/02/39042234",
                      "LocationContactEMail":"frapenagini@tiscali.it"
                    },{
                      "LocationContactName":"Alessandra Viganò, Paediatrician",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Francesca Di Nello, Doctor",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Vania Giacomet, Paediatrician",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Gian Vincenzo Zuccotti, Full Professor",
                      "LocationContactRole":"Principal Investigator"
                    },{
                      "LocationContactName":"Paola Erba, Paediatrician",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Valeria Manfredini, Doctor",
                      "LocationContactRole":"Sub-Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000014612",
                "InterventionMeshTerm":"Vaccines"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000007155",
                "InterventionAncestorTerm":"Immunologic Factors"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M15943",
                "InterventionBrowseLeafName":"Vaccines",
                "InterventionBrowseLeafAsFound":"Vaccine",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M8784",
                "InterventionBrowseLeafName":"Immunologic Factors",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16833",
                "ConditionBrowseLeafName":"HIV Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M2103",
                "ConditionBrowseLeafName":"Acquired Immunodeficiency Syndrome",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC02",
                "ConditionBrowseBranchName":"Viral Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              }
            ]
          }
        }
      }
    }
  }
}