[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496573":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":56,"studyPopulation":48,"armGroups":57,"interventions":70,"overallOfficials":82,"centralContacts":86,"locations":91,"responsibleParty":213,"collaborators":48,"id":215,"slug":216,"hasResults":217,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":223,"sex":224,"minAge":225,"maxAge":48,"enrollmentInfo":226,"targetDuration":48,"studyType":229,"phases":230,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":94,"whyStopped":48,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},{"fullName":5,"class":6},"McMaster University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":38},[9,13],{"measure":10,"description":11,"timeFrame":12},"PCR-confirmed Mpox","To evaluate if smallpox vaccine vs control prevents RT-PCR confirmed mpox","8 weeks",{"measure":14,"description":15,"timeFrame":12},"Symptom severity","To evaluate if smallpox vaccine vs control affects symptom severity",[17,20,23,26,29,32,35],{"measure":18,"description":19,"timeFrame":12},"Resolution of skin lesions","To assess the time to resolution (i.e. a new skin layer has formed) of any skin lesion",{"measure":21,"description":22,"timeFrame":12},"Number of skin lesions","To assess the number of skin lesions for any participants who develop mpox",{"measure":24,"description":25,"timeFrame":12},"Self-reported Quality of Life","To assess the QOL of participants using the World Health Organization Quality of Life Scale",{"measure":27,"description":28,"timeFrame":12},"Mpox complications","To assess longitudinal complications for any participants who develop mpox",{"measure":30,"description":31,"timeFrame":12},"Mpox Pain","To assess pain using an adapted Zoster Brief Pain Inventory",{"measure":33,"description":34,"timeFrame":12},"Hospitalization","To determine all cause hospitalization over the study period",{"measure":36,"description":37,"timeFrame":12},"Mortality","To determine all cause mortality over the study period",[39],{"measure":40,"description":41,"timeFrame":42},"Safety (SAEs, AESI)","Solicited SAE and AESIs will be followed at 4 months and 6 months","6 months",{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":48,"timePerspective":48,"maskingInfo":49},"RANDOMIZED","PARALLEL","Each group will be randomly selected to receive the smallpox vaccine or the typhoid vaccine","PREVENTION",null,{"masking":50,"maskingDescription":51,"whoMasked":52},"TRIPLE","Participants will not know which vaccine they receive until after the study is completed.",[53,54,55],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","A pragmatic, adaptive, multi-site, cluster randomized trial where households with one or more persons confirmed to have mpox will be randomized to smallpox vaccine or control. The co-primary outcomes are RT-PCR confirmed mpox and symptom severity.",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"Smallpox vaccine","EXPERIMENTAL","Participants will receive the Bavarian Nordic smallpox vaccine 0.5 ml single-dose",[63],"Drug: Bavarian Nordic smallpox vaccine",{"label":65,"type":66,"description":67,"interventionNames":68},"Typhoid vaccine","ACTIVE_COMPARATOR","Participants will receive the Typhim Vi® typhoid vaccine 0.5 ml single-dose",[69],"Drug: Typhoid VI Polysaccharide Vaccine Injectable Solution",[71,78],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"DRUG","Bavarian Nordic smallpox vaccine","A single dose of the Bavarian Nordic smallpox vaccine will be given at baseline.",[59],[77],"Imvamune",{"type":72,"name":79,"description":80,"armGroupLabels":81,"otherNames":48},"Typhoid VI Polysaccharide Vaccine Injectable Solution","A single dose of the typhoid vaccine will be given at baseline.",[65],[83],{"name":84,"affiliation":5,"role":85},"Mark Loeb, MD","PRINCIPAL_INVESTIGATOR",[87],{"name":84,"role":88,"phone":89,"phoneExt":48,"email":90},"CONTACT","9055259140","loebm@mcmaster.ca",[92,110,124,132,143,154,165,176,187,198],{"facility":93,"status":94,"city":95,"state":96,"zip":48,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Catholic University of Bukavu","RECRUITING","Kinshasa","Bukavu","Democratic Republic of the Congo","CD",{"type":100,"coordinates":101},"Point",[102,103],15.31357,-4.32758,{"lat":103,"lon":102},[106,108],{"name":107,"role":88,"phone":48,"phoneExt":48,"email":48},"Patrick Katoto, MD",{"name":109,"role":88,"phone":48,"phoneExt":48,"email":48},"Esto Bahizire, MD",{"facility":111,"status":112,"city":113,"state":48,"zip":48,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Federal Medical Center","NOT_YET_RECRUITING","Abuja","Nigeria","NG",{"type":100,"coordinates":117},[118,119],7.49508,9.05785,{"lat":119,"lon":118},[122],{"name":123,"role":88,"phone":48,"phoneExt":48,"email":48},"Haroun Adamu, MD",{"facility":125,"status":112,"city":113,"state":48,"zip":48,"country":114,"countryCode":115,"cosmosGeoPoint":126,"geoPoint":128,"contacts":129},"University of Abuja Teaching Hospital",{"type":100,"coordinates":127},[118,119],{"lat":119,"lon":118},[130],{"name":131,"role":88,"phone":48,"phoneExt":48,"email":48},"Zaiyad Garba, MD",{"facility":133,"status":112,"city":134,"state":48,"zip":48,"country":114,"countryCode":115,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"University of Ibadan","Ibadan",{"type":100,"coordinates":136},[137,138],3.90591,7.37756,{"lat":138,"lon":137},[141],{"name":142,"role":88,"phone":48,"phoneExt":48,"email":48},"Olukemi Adekanmbi, MD",{"facility":144,"status":112,"city":145,"state":48,"zip":48,"country":114,"countryCode":115,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Irrua Specialist Teaching Hospital","Irrua",{"type":100,"coordinates":147},[148,149],6.21984,6.73634,{"lat":149,"lon":148},[152],{"name":153,"role":88,"phone":48,"phoneExt":48,"email":48},"Sebastine Oiwoh, MD",{"facility":155,"status":112,"city":156,"state":48,"zip":48,"country":114,"countryCode":115,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Aminu Kano Teaching Hospital","Kano",{"type":100,"coordinates":158},[159,160],8.51672,12.00012,{"lat":160,"lon":159},[163],{"name":164,"role":88,"phone":48,"phoneExt":48,"email":48},"Garba Ilyasu, MD",{"facility":166,"status":112,"city":167,"state":48,"zip":48,"country":114,"countryCode":115,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Lagos University Teaching Hospital","Lagos",{"type":100,"coordinates":169},[170,171],3.39467,6.45407,{"lat":171,"lon":170},[174],{"name":175,"role":88,"phone":48,"phoneExt":48,"email":48},"Iorhen Ephraim, MD",{"facility":177,"status":112,"city":178,"state":48,"zip":48,"country":114,"countryCode":115,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Niger Delta Teaching Hospital","Okolobiri",{"type":100,"coordinates":180},[181,182],6.31919,5.03451,{"lat":182,"lon":181},[185],{"name":186,"role":88,"phone":48,"phoneExt":48,"email":48},"Dimie Ogoina, MD",{"facility":188,"status":112,"city":189,"state":48,"zip":48,"country":114,"countryCode":115,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"University of Port Harcourt Teaching Hospital","Port Harcourt",{"type":100,"coordinates":191},[192,193],7.0134,4.77742,{"lat":193,"lon":192},[196],{"name":197,"role":88,"phone":48,"phoneExt":48,"email":48},"Datonye Alasia, MD",{"facility":199,"status":112,"city":200,"state":48,"zip":48,"country":201,"countryCode":202,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Makerere University Lung Institute","Kampala","Uganda","UG",{"type":100,"coordinates":204},[205,206],32.58219,0.31628,{"lat":206,"lon":205},[209,211],{"name":210,"role":88,"phone":48,"phoneExt":48,"email":48},"Bruce Kirenga, PhD",{"name":212,"role":88,"phone":48,"phoneExt":48,"email":48},"Winters Muttamba, MD",{"type":214,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100496573","phase-4-smallpox-vaccine-for-mpox-post-exposure-prophylaxis-a-cluster-rct-100496573",false,"NCT05745987","Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT","SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)","SMART","Inclusion Criteria:\n\n1. Household member of person with laboratory confirmed mpox\n2. Age ≥ 2 years\n3. Within 14 days of onset of illness in mpox index case\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Breastfeeding\n3. Past serious allergic reaction to study vaccine components\n4. Previous smallpox vaccination\n5. Current or planned use of another investigational drug at any point during study participation",true,"ALL","2 Years",{"count":227,"type":228},3000,"ESTIMATED","INTERVENTIONAL",[231],"PHASE4","A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.",[234],"Monkeypox",[236],"mpox","2025-07-03",{"date":239,"type":240},"2025-07-06","ACTUAL",{"date":242,"type":240},"2024-09-17",{"date":244,"type":228},"2026-12-01",{"name":5,"class":6},10]