[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627952":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":38,"responsibleParty":96,"collaborators":28,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":28,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":125,"whyStopped":28,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Institute of Tropical Medicine, Belgium","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: 2 x 1IM regimen, (N = 187):","EXPERIMENTAL","Healthy volunteers that received Pre-Exposure Prohphylaxis (PrEP) (a rabies vaccination) at least 5 years ago through 1 x 1,0 mL IM injection (Day 0 and Day 7), with a 7-day interval between visits (interval of 5 to 56 days is allowed).",[13],"Biological: Booster vaccination",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2: 2²ID regimen (N = 187):","Received PrEP vaccination (Pre-Exposure prophylaxis usinga rabies vaccine) at least 5 years ago through 2 x 0,1 mL ID injections (Day 0 and Day 7) with a 7-day interval between visits (interval of 5 to 56 days is allowed).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group 3: 1²ID regimen (N = 187)","received PrEP (Pre-Exposure prophylaxis using a rabies vaccine) at least 5 years ago through 2 x 0,1 mL ID injections on Day 0",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","Booster vaccination","To investigate whether the boostability of a (A) two-visit IM, (B) two-visit ID and (C) one-visit ID pre-exposure vaccination regimen is non-inferior to a theoretical 99% boostability by administering a single-dose IM booster to simulate exposure to rabies at least 5 years after the pre-exposure regimens regimen.",[9,15,19],null,[30,35],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Thomas Hendrickx, MsC","CONTACT","000000000000000000000000000000","thendrickx@itg.be",{"name":36,"role":32,"phone":33,"phoneExt":28,"email":37},"Clinical Trial Unit Clinical Trial Unit Insitute of Tropical Medicine Antwerp, MsC","ctu@itg.be",[39,51,60,69,78,87],{"facility":40,"status":28,"city":41,"state":28,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":28},"Clinical Trial Site Insitute of Tropical Medicine","Antwerp","2000","Belgium","BE",{"type":46,"coordinates":47},"Point",[48,49],4.40026,51.22047,{"lat":49,"lon":48},{"facility":52,"status":28,"city":53,"state":28,"zip":54,"country":43,"countryCode":44,"cosmosGeoPoint":55,"geoPoint":59,"contacts":28},"Cliniques Universitaires de Saint Luc","Brussels","1200",{"type":46,"coordinates":56},[57,58],4.34878,50.85045,{"lat":58,"lon":57},{"facility":61,"status":28,"city":62,"state":28,"zip":63,"country":43,"countryCode":44,"cosmosGeoPoint":64,"geoPoint":68,"contacts":28},"Centrum voor vaccinologie (CEVAC)","Ghent","9000",{"type":46,"coordinates":65},[66,67],3.71667,51.05,{"lat":67,"lon":66},{"facility":70,"status":28,"city":71,"state":28,"zip":72,"country":43,"countryCode":44,"cosmosGeoPoint":73,"geoPoint":77,"contacts":28},"UZ Brussel","Jette","1090",{"type":46,"coordinates":74},[75,76],4.33419,50.87309,{"lat":76,"lon":75},{"facility":79,"status":28,"city":80,"state":28,"zip":81,"country":43,"countryCode":44,"cosmosGeoPoint":82,"geoPoint":86,"contacts":28},"Centre Hospitalier Universitaire de Liège","Liège","4000",{"type":46,"coordinates":83},[84,85],5.56749,50.63373,{"lat":85,"lon":84},{"facility":88,"status":28,"city":89,"state":28,"zip":90,"country":43,"countryCode":44,"cosmosGeoPoint":91,"geoPoint":95,"contacts":28},"Military Hospital Queen Astrid","Neder-Over-Heembeek","1120",{"type":46,"coordinates":92},[93,94],4.39221,50.90569,{"lat":94,"lon":93},{"type":97,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100627952","phase-3-boostability-assessment-of-three-rabies-pre-exposure-regimens-in-healthy-volunteers-5-years-following-priming-100627952",false,"NCT07455318","Boostability Assessment of Three Rabies Pre-Exposure Regimens in Healthy Volunteers 5 Years Following Priming.","A Multicentre, Open-label Trial in Healthy Volunteers to Assess the Boostability of Three Different Rabies Pre-exposure Prophylaxis Regimens When Administering a Single-dose, Intramuscular Vaccination as Simulated Post-exposure Prophylaxis at Least Five Years Following Priming.","BAZOOKA_221","Inclusion Criteria:\n\n1. ≥ 18 to ≤ 60 years of age at time of inclusion\n2. Willingness to provide written informed consent\n3. Having received PrEP with a 21IM, 2²ID or 1²ID regimen at least 5 years before starting the study. For 21IM and 2²ID interval of 5 days to 56 days between the 2 visits is allowed.\n\nExclusion Criteria:\n\n1. Known allergy to one of the components of the vaccine.\n2. Subjects, who received immunomodulating therapy within the last 3 months (12 weeks).\n\n   Note: See Section 6.3 for detailed guidance on immunomodulating therapies.\n3. Planned vaccination with any inactivated vaccine within 2 weeks before or after vaccination in the study or with any live attenuated vaccine within 1 month before or after each vaccination in the study.\n4. Ongoing pregnancy or active child wish at the time of booster vaccination (D0).\n5. Any other PrEP rabies vaccine schedule\u002Fvaccination than mentioned in the inclusion criteria.\n6. Previous rabies (s)PEP\n7. Inability or unwillingness to comply with study procedures, including protocol-defined visits, assessments, or interventions.","ALL","18 Years","60 Years",{"count":110,"type":111},561,"ESTIMATED","INTERVENTIONAL",[114],"PHASE3","A multicentre, open label trial in healthy volunteers to assess the boostability of three different rabies pre-exposure prophylaxis regimens (2 x 1IM regimen, 2 x 2 ID regimen, 1 x 2 ID regimen) when administering a single-dose, intramuscular vaccination as simulated post-exposure prophylaxis at least five years following priming.",[117],"Rabies (Healthy Volunteers)",[119,120,121,122,123,124],"Rabies","Vaccination regimens","rabies pre-exposure prophylaxis","boostability","prophylaxis","vaccination","NOT_YET_RECRUITING","2026-03-02",{"date":128,"type":129},"2026-03-06","ACTUAL",{"date":131,"type":111},"2026-05-15",{"date":133,"type":111},"2027-06",{"name":5,"class":6},6]