[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584170":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":24,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":60,"collaborators":24,"id":62,"slug":24,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":24,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":24,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Immunogenicity a of a booster dose of MVA-BN vaccine","To evaluate the immunogenicity at 12 months of a booster dose of MVA-BN vaccine administered subcutaneously in HIV PrEP users.","12 months",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Persistence of humoral immunogenicity","Evaluate the persistence of humoral immunogenicity at 24 months of a booster dose, depending on the number of doses and the interval between doses","24 months",{"measure":19,"description":20,"timeFrame":17},"Kinetics of the humoral response","Study the kinetics of the humoral response as a function of the number of doses and the interval between doses",{"measure":22,"description":23,"timeFrame":17},"Description of cases of Mpox infection","Describe cases of Mpox infection based on number of doses and dose interval up to 24 month",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","PROSPECTIVE","Mpox is an endemic zoonosis in Africa, caused by the MPXV virus of which there are two clades: I (former Congo Basin) and II (former West Africa). Since 2022, clade II has emerged globally via sexual transmission, primarily among men who have sex with men (MSM), resulting in a declaration of public health emergency (PHEIC) by the WHO.\n\nIn 2023, a clade I epidemic emerged in East Africa with a high case fatality rate (3-5%). In August 2024, the WHO again declared a PHEIC after the spread of clade I to African countries with no previously reported cases and outside Africa, raising fears of higher mortality and transmission.\n\nA 3rd generation vaccine, MVA-BN (Imvanex® \u002FJynneos®), initially developed against smallpox, was approved in 2022 to prevent mpox. In France, the HAS recommends post- and pre-exposure vaccination for populations at risk: MSM, trans people with multiple partners, sex workers and certain professionals. For people born before 1980 (history of smallpox vaccination), a single dose is recommended as primary vaccination, while immunocompromised subjects require 3 doses.\n\nData show vaccine effectiveness of 20-80% in post-exposure prophylaxis (PEP) and \\~80% in pre-exposure but neutralizing antibodies become undetectable after one year. Since the summer of 2024, the HAS has recommended a booster dose 2 years after the primary vaccination, on the basis of immunogenicity studies showing an increase in seroconversion to 98.7% one month after administration, but underlines the need to have other data, in particular on the durability of this response.\n\nA study is proposed in MSM on HIV PrEP (pre-exposure prophylaxis), a priority population for structured medical monitoring, to evaluate the immunogenicity and safety of the MVA-BN booster in this context.","The study population will consist of Men who have Sex with Men (MSM), taking HIV pre-exposure prophylaxis (HIV PrEP), eligible for MVA-BN vaccination.",[31],{"name":32,"affiliation":5,"role":33},"Liem Binh Luong Nguyen, Degree medical doctor","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":24,"email":38},"CONTACT","0033 1 58 41 28 58","liem.luong@aphp.fr",{"name":40,"role":36,"phone":37,"phoneExt":24,"email":41},"Odile LAUNAY, PUPH","odile.launay@aphp.fr",[43],{"facility":44,"status":45,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"CIC 1417Cochin-Pasteur","RECRUITING","Paris","75679","France","FR",{"type":51,"coordinates":52},"Point",[53,54],2.3488,48.85341,{"lat":54,"lon":53},[57,58],{"name":32,"role":36,"phone":37,"phoneExt":24,"email":38},{"name":40,"role":36,"phone":59,"phoneExt":24,"email":41},"00 33 1 58 41 28 58",{"type":61,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100584170",false,"NCT06885853","Evaluation of Long-term Immunogenicity of a Boost Dose of MVA-BN Vaccine","M-BOOST-FR","Inclusion Criteria:\n\n* Men aged over 18 years\n* Have received two doses of MVA-BN vaccine as an initial schedule\n* Eligible for a booster dose of MVA-BN (according to the HAS recommendation)\n* Be eligible and wish to initiate PrEP-HIV treatment or be followed for PrEP-HIV treatment\n* Covered by social security (excluding AME)\n\nExclusion Criteria:\n\n* History of mpox (virologically confirmed)\n* Be under guardianship or curatorship\n* Be subject to a judicial protection measure\n* Have a contraindication to vaccination against mpox","ALL","18 Years",{"count":71,"type":72},90,"ESTIMATED","OBSERVATIONAL","This study is to evaluate the long-term immunogenicity of a boost dose of MVA-BN vaccine",[76],"Monkeypox",[76,78,79],"MVA-BN booster vaccine","HIV pre-exposure prophylaxis","2025-05-14",{"date":82,"type":83},"2025-05-15","ACTUAL",{"date":85,"type":83},"2025-05-07",{"date":87,"type":72},"2027-11",{"name":5,"class":6},1]