[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100408357":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":27,"centralContacts":27,"locations":38,"responsibleParty":98,"collaborators":27,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":27,"enrollmentInfo":110,"targetDuration":27,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":123,"whyStopped":27,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"doxycycline and Bexsero® vaccine","EXPERIMENTAL","-doxycycline will be taken by participants as PEP (prophylaxy post exposition) and participants will received Meningococcal B vaccine (Bexsero®) at D0 and M2",[13,14],"Drug: Experimental: doxycycline","Biological: Bexsero® vaccine",{"label":16,"type":10,"description":17,"interventionNames":18},"doxycycline","-doxycycline will be taken by participants as PEP (prophylaxy post exposition)",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Bexsero® vaccine","-Meningococcal B vaccine (Bexsero®) at D0 and M2",[14],{"label":24,"type":25,"description":26,"interventionNames":27},"No treatment","NO_INTERVENTION","-no doxycycline and no Bexsero® vaccine",null,[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":27},"DRUG","Experimental: doxycycline","2 tablets of doxycycline 100 mg (monohydrate form) will be taken orally after each risk sexual intercourse, ideally within 24 hours after sex and no more than 72 hours. PEP should not be taken more than 3 times over a 7 days' period.\n\nIf a participant has risk sexual intercourse for several consecutive days, PEP should be taken at least 48 hours apart and no more than 3 times 2 tablets over 7 days. A maximum of 3 intakes of 2 tablets will be allowed over a period of 7 days.",[16,9],{"type":35,"name":20,"description":36,"armGroupLabels":37,"otherNames":27},"BIOLOGICAL","1st injection of Bexsero® vaccine at inclusion visit, 2nd injection at week 8.",[20,9],[39,51,57,63,69,75,80,86,92],{"facility":40,"status":27,"city":41,"state":27,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":27},"Hôpital Bichat","Paris","75000","France","FR",{"type":46,"coordinates":47},"Point",[48,49],2.3488,48.85341,{"lat":49,"lon":48},{"facility":52,"status":27,"city":41,"state":27,"zip":53,"country":43,"countryCode":44,"cosmosGeoPoint":54,"geoPoint":56,"contacts":27},"Hôpital Hôtel Dieu","75181",{"type":46,"coordinates":55},[48,49],{"lat":49,"lon":48},{"facility":58,"status":27,"city":41,"state":27,"zip":59,"country":43,"countryCode":44,"cosmosGeoPoint":60,"geoPoint":62,"contacts":27},"Hôpital Saint-Louis","75475",{"type":46,"coordinates":61},[48,49],{"lat":49,"lon":48},{"facility":64,"status":27,"city":41,"state":27,"zip":65,"country":43,"countryCode":44,"cosmosGeoPoint":66,"geoPoint":68,"contacts":27},"Hôpital Saint-Antoine","75571",{"type":46,"coordinates":67},[48,49],{"lat":49,"lon":48},{"facility":70,"status":27,"city":41,"state":27,"zip":71,"country":43,"countryCode":44,"cosmosGeoPoint":72,"geoPoint":74,"contacts":27},"Hôpital pitié Salpetrière","75651",{"type":46,"coordinates":73},[48,49],{"lat":49,"lon":48},{"facility":76,"status":27,"city":41,"state":27,"zip":71,"country":43,"countryCode":44,"cosmosGeoPoint":77,"geoPoint":79,"contacts":27},"Hôpital Pitié-Salpétrière",{"type":46,"coordinates":78},[48,49],{"lat":49,"lon":48},{"facility":81,"status":27,"city":41,"state":27,"zip":82,"country":43,"countryCode":44,"cosmosGeoPoint":83,"geoPoint":85,"contacts":27},"Hôpital Necker-Enfants Malades","75743",{"type":46,"coordinates":84},[48,49],{"lat":49,"lon":48},{"facility":87,"status":27,"city":41,"state":27,"zip":88,"country":43,"countryCode":44,"cosmosGeoPoint":89,"geoPoint":91,"contacts":27},"Hôpital Européen Georges Pompidou","75908",{"type":46,"coordinates":90},[48,49],{"lat":49,"lon":48},{"facility":93,"status":27,"city":41,"state":27,"zip":94,"country":43,"countryCode":44,"cosmosGeoPoint":95,"geoPoint":97,"contacts":27},"Hôpital Tenon","75970",{"type":46,"coordinates":96},[48,49],{"lat":49,"lon":48},{"type":99,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100408357","phase-3-combined-prevention-of-sexually-transmitted-infections-stis-in-men-who-have-sex-with-men-and-using-oral-tenofovir-disoproxil-fumarate-emtricitabine-tdfftc-for-hiv-pre-exposure-prophylaxis-prep-100408357",false,"NCT04597424","Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate\u002F Emtricitabine (TDF\u002FFTC) for HIV Pre-Exposure Prophylaxis (PrEP)","DOXYVAC","Inclusion Criteria:\n\n* Mens who have sex with mens (MSM) enrolled in the ANRS PREVENIR study.\n* At least 6-month experience with PrEP (within the ANRS PREVENIR study or before starting the ANRS PREVENIR study).\n* No clinical manifestation of primary HIV infection and no symptom of bacterial STI (chlamydia, gonorrhea, M. genitalium or syphilis).\n* History of documented bacterial STI with at least one episode in the last 12 months.\n* Participants who agree to sign the information and consent form specific to this study.\n* Valid health insurance (State medical aid (AME) is not health insurance).\n\nExclusion Criteria:\n\n* Syphilis diagnosed prior to inclusion without serologic evidence of cure (cure is defined as decreased by at least 4-fold of the non-treponemal antibody titer \\[Venereal Disease Research Laboratory (VDRL), Rapid Plasma Reagin (RPR)\\] relative to the titer at initiation of treatment of syphilis).\n* HIV infection.\n* Previous vaccination with Bexsero® or any other meningococcal B vaccine.\n* Vaccination during the 4 weeks (28 days) preceding the first vaccination of the study.\n* Previous vaccination with an experimental vaccine in the previous 5 years.\n* Systemic treatment with retinoids : isotretinoin (Acnetrait®, Procuta®, Curacné®, Contracné®, …).\n* Treatment with enzyme-inducing anticonvulsants (carbamazepine, phenobarbital, phenytoin, ….).\n* Participant who has received immunoglobulins, a transfusion of blood or blood derivatives in the last 3 months.\n* Known or suspected congenital or acquired immunodeficiency; immunosuppressive treatment in the last 6 months, such as cancer chemotherapy or radiotherapy; long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks in the last 3 months)\n* Known allergy to antibiotics of the tetracycline family.\n* Known allergy to any component of the Bexsero® vaccine.\n* Known allergy to any component of the doxycycline pill.\n* Known allergy to latex (contained in the vaccine cap).\n* Thrombocytopenia or any other known coagulation disorder, which would be a contraindication to an intramuscular injection of Bexsero® vaccine.\n* Documented oesophageal lesion\n* Acute respiratory infection or severe acute febrile illness or systemic reaction that may present a significant risk if vaccinated in the month prior to inclusion.\n* Any condition (clinical) that, in the investigator's opinion, would contraindicate intramuscular vaccination and blood sampling.\n* Oral Anticoagulant treatment.\n* Continuous treatment with doxycycline at inclusion.\n* Vitamin A treatment in case of intake of 10 000 international unit or more.\n* Participation in another research including an exclusion period still in progress at the time of inclusion.\n* Under guardianship or curator, or deprived of liberty by a judicial or administrative decision.",true,"MALE","18 Years",{"count":111,"type":112},556,"ACTUAL","INTERVENTIONAL",[115],"PHASE3","The study ANRS 174 Doxyvac is a clinical trial that will use Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men and using oral TDF\u002FFTC for HIV Pre-Exposure Prophylaxis (PrEP) and vaccination with Bexsero.",[118,119],"Unsafe Sex","Risk-Taking",[121,122],"STI infection","PREVENTION","COMPLETED","2026-04-01",{"date":126,"type":112},"2026-04-06",{"date":128,"type":112},"2021-01-19",{"date":130,"type":112},"2024-04-19",{"name":5,"class":6},9]