[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580769":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":50,"responsibleParty":114,"collaborators":116,"id":144,"slug":145,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":146,"sex":152,"minAge":53,"maxAge":53,"enrollmentInfo":153,"targetDuration":53,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":166,"whyStopped":53,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ervebo vaccine alone","ACTIVE_COMPARATOR","Administration of Ervebo vaccine (72 million PFU IM) at day 1",[13],"Biological: Ervebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Ervebo + Inmazeb","EXPERIMENTAL","Administration of Ervebo vaccine (72 million PFU IM) and Inmazeb IV (150 mg\u002Fkg) at day 1 and Inmazeb IV (150 mg\u002Fkg) at day 56",[13,19],"Biological: Inmazeb",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Ervebo","Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP, live, attenuated) ≥ 72 million PFU, composed of the Indiana strain of recombinant vesicular stomatitis virus (rVSV) with a deletion of the envelope glycoprotein (G) of VSV replaced by the surface glycoprotein (GP) of the Kikwit 1995 strain of Ebola virus Zaire (ZEBOV)",[15,9],[27],"r-VSV-ZEBOV vaccine",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Inmazeb","Inmazeb (REGN-EB3), developed by Regeneron, is a cocktail of 3 neutralising humanised mAbs directed against 3 epitopes of the EBOV GP (atoltivimab, maftivimab and odesivimab). It is indicated for the treatment of EVD in adult patients (including pregnant women) and in children, including neonates born to mothers with confirmed EVD.",[15],[33],"REGN-EB3",[35],{"name":36,"affiliation":37,"role":38},"Placide MBALA, MD, MSPH, PhD","INRB","STUDY_CHAIR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Marie JASPARD, MD, PHD","CONTACT","0658809012","+33","marie.jaspard@aphp.fr",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Alice MONTOYO, PharmD","0660162965","alice.montoyo@alima.coral.ngo",[51,69,85,99],{"facility":52,"status":53,"city":54,"state":53,"zip":53,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"National Institute for Biomedical Research (INRB)",null,"Kinshasa","Democratic Republic of the Congo","CD",{"type":58,"coordinates":59},"Point",[60,61],15.31357,-4.32758,{"lat":61,"lon":60},[64],{"name":65,"role":42,"phone":66,"phoneExt":67,"email":68},"Placide Mbala, MD, MSPH, PhD","822 851 584","+243","mbalaplacide@gmail.com",{"facility":70,"status":53,"city":71,"state":53,"zip":53,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Guinea Centre for Research and Training in Infectious Diseases (CERFIG)","Conakry","Guinea","GN",{"type":58,"coordinates":75},[76,77],-13.67729,9.53795,{"lat":77,"lon":76},[80],{"name":81,"role":42,"phone":82,"phoneExt":83,"email":84},"Abdoulaye Toure, MD, MSPH, PhD","666 64 65 66","+224","abdoulaye.toure@cerfig.org",{"facility":86,"status":53,"city":87,"state":53,"zip":53,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"National Public Health Institute of Liberia","Monrovia","Liberia","LR",{"type":58,"coordinates":91},[92,93],-10.7969,6.30054,{"lat":93,"lon":92},[96],{"name":97,"role":42,"phone":53,"phoneExt":53,"email":98},"Dougbeh Chris Nyan, MD","dnyan@doctor.com",{"facility":100,"status":53,"city":101,"state":53,"zip":53,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"University of Sierra Leone College of Medicine and Allied Health Sciences","Freetown","Sierra Leone","SL",{"type":58,"coordinates":105},[106,107],-13.2356,8.48714,{"lat":107,"lon":106},[110],{"name":111,"role":42,"phone":112,"phoneExt":53,"email":113},"Alhaji N'Jai, MD, PHD","+23278375157","alhaji.njai@gmail.com",{"type":115,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[117,120,123,125,127,129,131,133,135,137,139,141,143],{"name":118,"class":119},"Alliance for International Medical Action","OTHER",{"name":121,"class":122},"Centre de Recherche et de Formation en Infectiologie de Guinée (CERFIG)","UNKNOWN",{"name":124,"class":119},"Medecins Sans Frontieres, Netherlands",{"name":126,"class":119},"Barcelona Institute for Global Health",{"name":128,"class":119},"University of Bordeaux",{"name":130,"class":119},"INSERM UMR S 1136",{"name":132,"class":122},"Agence Nationale de Sécurité Sanitaire de Guinée (ANSS)",{"name":134,"class":122},"National Institute for Biomedical Research DRC",{"name":136,"class":119},"Cheikh Anta Diop University, Senegal",{"name":138,"class":119},"PACCI Program",{"name":140,"class":122},"The PANdemic preparedness plaTform for Health and Emerging infectious Response",{"name":142,"class":119},"University of Sierra Leone",{"name":86,"class":122},"100580769","phase-3-ebola-post-exposure-prophylaxis-100580769",false,"NCT06841614","EBOla Post-Exposure Prophylaxis","Evaluation of the Efficacy of a Post-exposure Prophylaxis (PEP) Strategy in Contacts at High Risk of Developing Ebola Virus Disease (EVD)","EBO-PEP","Inclusion criteria\n\n* Last high-risk contact within the last 5 days\n* No sign or symptoms of EVD\n* Signed and dated informed consent from participants over the age of majority to participate in the trial or from a representative of parental authority for minor participants.\n\nNon-inclusion criteria\n\n* History of vaccination with Ervebo or any other EVD vaccine within the last 5 years (self-reported by the participant)\n* History of confirmed EVD within the last 5 years (self-reported by the participant)\n* Hypersensitivity to any of the experimental medical products (IMP) or their excipients (self-reported by the participant)\n* Participation in another therapeutic or vaccine trial for EVD\n* Any other reason that, at the investigator's discretion, could compromise the participant's safety and cooperation in the trial.","ALL",{"count":154,"type":155},160,"ESTIMATED","INTERVENTIONAL",[158],"PHASE3","EBO-PEP is a multicentre, multi-epidemic, phase III, comparative, controlled, randomised, strict superiority trial in two unblinded parallel arms.\n\nThe trial will be open during EVD epidemics and will recruit asymptomatic participants at high risk of developing EVD.\n\nParticipants will be randomized (1:1) into one of two trial arms:\n\n* Arm 1 (ERV): Ervebo D0 (72 million PFU IM)\n* Arm 2 (ERV+IMZ): Ervebo D0 (72 million PFU IM) + Inmazeb IV (150 mg\u002Fkg) D0 + Ervebo D56 (revaccination)\n\nDefinition of high-risk:\n\nDirect contact with a person with EBOV PCR-confirmed EVD with diarrhea, vomiting or external bleeding (\"wet symptoms\"), or with their body fluids; Direct contact with the dead body of a person with confirmed or probable EVD; Needlestick with a syringe contaminated by the blood of a person with confirmed or probable EVD; Or a child born to or breastfed by an individual with EVD\n\nTrial follow-up All participants are monitored daily for a minimum of 21 days.\n\nSome visits are conducted in person at the investigation site, also called the Post-Exposure Prophylaxis (PEP) center:\n\n* at Day 5, Day 10, and Day 21 for the ERV arm,\n* at Day 5, Day 10, Day 21, and Day 56 for the ERV+IMZ arm. Other visits are conducted at home or by phone, in collaboration with the Ministry of Health's surveillance team.\n\nParticipants in the ERV+IMZ arm have an in-person visit at Day 56 to be revaccinated with the Ervebo vaccine to compensate for potential inhibition of the vaccine response when Ervebo is administered simultaneously with Inmazeb.\n\nParticipants in the ERV arm have a phone visit at Day 56. For all participants, a phone visit is scheduled at Day 60. It corresponds to the last visit for all trial participants.\n\nFollow-up in Case of Hospitalisation In case of clinical signs suggestive of EVD, participants enter the suspected case management pathway at the Ebola Treatment Center (ETC).\n\nIf EVD is confirmed by EBOV PCR, participants are allowed at the ETC, and their study samples are discontinued. They continue to be followed by the research team, and daily data are collected throughout their stay at the ETC until they are discharged alive or deceased. The day of discharge from the ETC marks the end of follow-up in the study for these participants.\n\nOf note, participants in the ERV+IMZ arm who have confirmed EVD are not revaccinated at day 56.\n\nOf note, participants in the ERV+IMZ arm who have confirmed EVD are not revaccinated at day 56.\n\nIf EVD is not confirmed, participants continue to be followed up by the PEP center according to the protocol.",[161],"Ebola Virus Disease",[161,163,164,165],"EBOV","High-Risk contact","Post-Exposure Prophylaxis","NOT_YET_RECRUITING","2026-01-21",{"date":169,"type":170},"2026-01-22","ACTUAL",{"date":172,"type":155},"2026-09",{"date":174,"type":155},"2028-08-01",{"name":5,"class":6},4]