[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100165403":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":24,"locations":38,"responsibleParty":50,"collaborators":24,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":24,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":24,"overallStatus":74,"whyStopped":24,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Voluntary HIV positive subjects","ACTIVE_COMPARATOR","40 HIV positive adults under HAART for at least one year (and stable on treatment for at least 3 months prior to enrolment), \\> 350 CD4\u002Fmm3 (with half of them a nadir \\\u003C 200 CD4\u002Fmm3) and a viral load \\\u003C 50 copies\u002FmL for at least 6 months. Patients were HCV negative or non-replicative and treated for at least 2 years with normal ALT and negative HBs antigen.",[13],"Biological: Yellow fever vaccination (STAMARIL)",{"label":15,"type":16,"description":17,"interventionNames":18},"HIV negative subjects","OTHER","Voluntary HIV negative subjects matched according to age (18-40 years and 40-55 years) and with HIV positive subjects, vaccinated at J0 and followed over one year",[13],[20,25],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","Yellow fever vaccination (STAMARIL)",[15,9],null,{"type":21,"name":22,"description":22,"armGroupLabels":26,"otherNames":24},[15],[28,32,35],{"name":29,"affiliation":30,"role":31},"Nathalie COLIN de VERDIERE","Maladies Infectieuses St Louis Paris","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Sophie MATHERON","Maladies Infectieuses et Tropicales Bichat Paris",{"name":36,"affiliation":37,"role":31},"Odile LAUNAY","CIC Cochin Paris",[39],{"facility":40,"status":24,"city":41,"state":24,"zip":24,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":24},"Voir Liste Des Centres","Paris","France","FR",{"type":45,"coordinates":46},"Point",[47,48],2.3488,48.85341,{"lat":48,"lon":47},{"type":51,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100165403","phase-3-the-yellow-fever-vaccine-immunity-in-hiv-infected-patients--development-of-new-assays-for-virological-and-immunological-monitoring-in-hiv-infected-patient-100165403",false,"NCT01426243","The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient.","The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient","EP46 NOVAA","Group 1: Voluntary HIV positive subjects\n\nInclusion Criteria:\n\n* Adults under HAART for at least one year (and stable on treatment for at least 3 months prior to enrolment)\n* \\> 350 CD4\u002Fmm3 (with half of them a nadir \\\u003C 200 CD4\u002Fmm3) and a viral load \\\u003C 50 copies\u002FmL for at least 6 months.\n* Patients were HCV negative or non-replicative and treated for at least 2 years with normal ALT and negative HBs antigen.\n\nExclusion Criteria:\n\n* Previous vaccination against yellow fever or yellow fever Fluorescence anti-IgG positive.\n* Administration of immunoglobulins \\\u003C 3 months or any vaccine \\\u003C1 month.\n* Pregnancy ongoing or planned during the study.\n* Coinfection with HCV virus untreated.\n* HBs Ag positive.\n* Hypersensitivity reaction to eggs \u002F chicken protein; hereditary fructose intolerance.\n* Immunosuppression, whether congenital, idiopathic or as a result of corticosteroids systemically (at doses ≥ 20mg\u002Fd of prednisone), or due to radiation or antineoplastic older than 6 months.\n* History of thymic dysfunction (including thymoma and thymectomy).\n* For HIV + subjects: ART Celsentri or by other anti-CCR5.\n\nGroup 2: HIV negative subjects\n\nInclusion Criteria:\n\nHIV and HCV negatives\n\nExclusion Criteria:\n\n* Previous vaccination against yellow fever or yellow fever Fluorescence anti-IgG positive.\n* Administration of immunoglobulins \\\u003C 3 months or any vaccine \\\u003C1 month.\n* Other vaccinations should be deferred beyond M3.\n* Pregnancy ongoing or planned during the study.\n* Coinfection with HCV virus untreated.\n* HBs Ag positive.\n* Hypersensitivity reaction to eggs \u002F chicken protein; hereditary fructose intolerance.\n* Immunosuppression, whether congenital, idiopathic or as a result of corticosteroids systemically (at doses ≥ 20mg\u002Fd of prednisone), or due to radiation or antineoplastic older than 6 months.\n* History of thymic dysfunction (including thymoma and thymectomy).\n* For HIV + subjects: ART Celsentri or by other anti-CCR5, coinfection with HCV virus untreated",true,"ALL","18 Years","55 Years",{"count":65,"type":66},71,"ACTUAL","INTERVENTIONAL",[69],"PHASE3","Main objective :\n\nTo develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negative individuals who had not been given YFV before.\n\nSecondary objectives :\n\n* To develop and assess ELISPOT technology for yellow fever and to measure the response within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects and 40 HIV positive subjects (CD4 \\> 350\u002Fmm3 under Highly Active Antiretroviral Therapy (HAART) for at least one year, with a viral load \\\u003C 50 copies\u002FmL since at least 6 months) in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in ELISPOT, (3) neutralizing antibody levels in Plaque reduction neutralization test (PRNT:reference method) and a new pseudotype based method, (4) post-vaccination viremia and (5) diversity of viral quasi-species.\n* To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and viral load.",[72,73],"HIV Infection","Yellow Fever","COMPLETED","2019-01-17",{"date":77,"type":66},"2019-01-18",{"date":79,"type":24},"2011-07",{"date":81,"type":66},"2017-12",{"name":83,"class":6},"French National Agency for Research on AIDS and Viral Hepatitis",1]