[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622127":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":62,"studyPopulation":50,"armGroups":63,"interventions":89,"overallOfficials":99,"centralContacts":103,"locations":110,"responsibleParty":162,"collaborators":164,"id":167,"slug":168,"hasResults":169,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":50,"eligibilityCriteria":173,"healthyVolunteers":174,"sex":175,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":50,"studyType":181,"phases":182,"briefSummary":184,"conditions":185,"keywords":189,"overallStatus":113,"whyStopped":50,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},{"fullName":5,"class":6},"BioNTech SE","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":50},[9,13,15,17,20,23,26,28,30],{"measure":10,"description":11,"timeFrame":12},"Number (and percentage) of participants with at least one solicited local reaction (pain, erythema\u002Fredness, induration\u002Fswelling)","At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.","For up to 7 days following each dose",{"measure":14,"description":11,"timeFrame":12},"Number (and percentage) of participants with at least one solicited systemic reaction (fever, headache, fatigue\u002Ftiredness, muscle pain\u002Fmyalgia, joint pain\u002Farthralgia, chills, diarrhea, vomiting)",{"measure":16,"description":11,"timeFrame":12},"Number (and percentage) of participants with at least one use of antipyretics\u002Fanalgesics",{"measure":18,"description":11,"timeFrame":19},"Number (and percentage) of participants with at least one unsolicited adverse event (AE) (post-Dose 1)","From Dose 1 to 28 days post-Dose 1",{"measure":21,"description":11,"timeFrame":22},"Number (and percentage) of participants with at least one unsolicited AE (post-Dose 2)","From Dose 2 to 28 days post-Dose 2",{"measure":24,"description":11,"timeFrame":25},"Number (and percentage) of participants with at least one serious adverse event","From Dose 1 until the end of study, i.e., up to ~14 months",{"measure":27,"description":11,"timeFrame":25},"Number (and percentage) of participants with at least one AE of special interest",{"measure":29,"description":11,"timeFrame":25},"Number (and percentage) of participants with at least one medically attended AE",{"measure":31,"description":11,"timeFrame":25},"Number (and percentage) of participants with at least one AE leading to a participant's withdrawal from the study",[33,37,41,44,46,48],{"measure":34,"description":35,"timeFrame":36},"Geometric mean titers (GMT) of BNT166a antigen-specific (A35, B6, H3, and M1) binding antibody titers","At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults, at the defined timepoints.","At baseline, 1 month post-Dose 1, and 1 month post- Dose 2",{"measure":38,"description":39,"timeFrame":40},"Geometric mean fold rise (GMFR) of BNT166a antigen-specific (A35, B6, H3, and M1) binding antibody titers","At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.\n\nRatio post-baseline\u002Fbaseline at the defined timepoints.","At 1 month post-Dose 1 and 1 month post-Dose 2",{"measure":42,"description":35,"timeFrame":43},"GMT of MPXV-specific neutralizing antibody titers","At baseline, 1 month post-Dose 1, and 1 month post-Dose 2",{"measure":45,"description":39,"timeFrame":40},"GMFR of MPXV-specific neutralizing antibody titers",{"measure":47,"description":35,"timeFrame":43},"GMT of vaccinia virus (VACV)-specific neutralizing antibody titers",{"measure":49,"description":39,"timeFrame":40},"GMFR of VACV-specific neutralizing antibody titers",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":56,"maskingDescription":50,"whoMasked":57},"QUADRUPLE",[58,59,60,61],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This study will include the following cohorts:\n\n* Cohort 1: healthy adults aged 18 to 45 years inclusive who are Orthopoxvirus-naïve.\n* Cohort 2: healthy adults aged 18 to 64 years inclusive who are Orthopoxvirus-experienced.\n\nAll participants will receive two doses of BNT166a or placebo at least 28 days apart.\n\nThe planned study duration per participant is \\~14 months.",[64,70,74,80,83,86],{"label":65,"type":66,"description":67,"interventionNames":68},"Cohort 1 - BNT166a Dose Level (DL) 1 (Orthopoxvirus-naïve participants, aged 18-45 years)","EXPERIMENTAL","Two doses of investigational medicinal product (IMP).",[69],"Biological: BNT166a",{"label":71,"type":66,"description":72,"interventionNames":73},"Cohort 1 - BNT166a DL 2 (Orthopoxvirus-naïve participants, aged 18-45 years)","Two doses of IMP.",[69],{"label":75,"type":76,"description":77,"interventionNames":78},"Cohort 1 - Placebo (Orthopoxvirus-naïve participants, aged 18-45 years)","PLACEBO_COMPARATOR","0.9% sodium chloride solution. Two doses of IMP.",[79],"Other: Placebo",{"label":81,"type":66,"description":72,"interventionNames":82},"Cohort 2 - BNT166a DL 1 (Orthopoxvirus-experienced participants, aged 18-64 years)",[69],{"label":84,"type":66,"description":72,"interventionNames":85},"Cohort 2 - BNT166a DL 2 (Orthopoxvirus-experienced participants, aged 18-64 years)",[69],{"label":87,"type":76,"description":77,"interventionNames":88},"Cohort 2 - Placebo (Orthopoxvirus-experienced participants, aged 18-64 years)",[79],[90,95],{"type":91,"name":92,"description":93,"armGroupLabels":94,"otherNames":50},"BIOLOGICAL","BNT166a","Intramuscular injection. Injections should be given in the deltoid muscle, using the same non-dominant arm for all IMP doses.",[71,65,81,84],{"type":96,"name":97,"description":93,"armGroupLabels":98,"otherNames":50},"OTHER","Placebo",[75,87],[100],{"name":101,"affiliation":5,"role":102},"BioNTech Responsible Person","STUDY_DIRECTOR",[104],{"name":105,"role":106,"phone":107,"phoneExt":108,"email":109},"BioNTech clinical trials patient information","CONTACT","+49 6131 9084","0","patients@biontech.de",[111,124,130,141,147,153],{"facility":112,"status":113,"city":114,"state":50,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":50},"University of Kinshasa UNIKIN","RECRUITING","Kinshasa","01306","Democratic Republic of the Congo","CD",{"type":119,"coordinates":120},"Point",[121,122],15.31357,-4.32758,{"lat":122,"lon":121},{"facility":125,"status":113,"city":114,"state":50,"zip":126,"country":116,"countryCode":117,"cosmosGeoPoint":127,"geoPoint":129,"contacts":50},"Institute National de Recherche Biomedicale","5345",{"type":119,"coordinates":128},[121,122],{"lat":122,"lon":121},{"facility":131,"status":113,"city":132,"state":50,"zip":133,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":50},"TASK Applied Science","Cape Town","7405","South Africa","ZA",{"type":119,"coordinates":137},[138,139],18.42322,-33.92584,{"lat":139,"lon":138},{"facility":142,"status":113,"city":132,"state":50,"zip":143,"country":134,"countryCode":135,"cosmosGeoPoint":144,"geoPoint":146,"contacts":50},"TREAD Research Pty Ltd","7530",{"type":119,"coordinates":145},[138,139],{"lat":139,"lon":138},{"facility":148,"status":113,"city":132,"state":50,"zip":149,"country":134,"countryCode":135,"cosmosGeoPoint":150,"geoPoint":152,"contacts":50},"Desmond Tutu Health Foundation Masiphumelele Clinic","7975",{"type":119,"coordinates":151},[138,139],{"lat":139,"lon":138},{"facility":154,"status":113,"city":155,"state":50,"zip":156,"country":134,"countryCode":135,"cosmosGeoPoint":157,"geoPoint":161,"contacts":50},"Perinatal HIV Research Unit","Johannesburg","1864",{"type":119,"coordinates":158},[159,160],28.04363,-26.20227,{"lat":160,"lon":159},{"type":163,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[165],{"name":166,"class":96},"Coalition for Epidemic Preparedness Innovations","100622127","phase-2-a-randomized-clinical-trial-investigating-the-safety-reactogenicity-and-immunogenicity-after-immunization-with-an-mrna-based-mpox-vaccine-candidate-in-africa-100622127",false,"NCT07379580","A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa","Safety, Reactogenicity, and Immunogenicity of an Mpox mRNA Vaccine Candidate, BNT166a, in Healthy Participants Aged 18 Years and Older in African Countries: A Randomized, Double-blind, Placebo-controlled Phase II Trial","Key Inclusion Criteria (applicable to all participants unless otherwise specified):\n\n* Are male or female individuals ≥18 years of age at the time of giving informed consent:\n\n  * Cohort 1: ≥18 to ≤45 years of age\n  * Cohort 2: ≥18 to ≤64 years of age\n* Cohort 1: Participants must be Orthopoxvirus-naïve (have no history of smallpox or mpox vaccination or mpox infection).\n* Cohort 2: Participants must be Orthopoxvirus-experienced (have evidence of mpox or smallpox vaccination or mpox infection at least 2 years prior to consent).\n\nKey Exclusion Criteria (applicable to all participants unless otherwise specified):\n\n* Have had recent exposure to mpox (defined as close contact with a probable or confirmed case of mpox within the past 28 days, or have evidence of mpox infection or mpox vaccination within 2 years prior to consent).\n* Have a contraindication, warning and\u002For precaution to vaccination with a messenger ribonucleic acid (mRNA) Coronavirus disease 2019 (COVID-19) vaccine as specified in the Summary of Product Characteristics for BNT162b2 (COMIRNATY United States Prescribing Information\u002FEuropean Union Summary of Product Characteristics) and BNT166 Investigator Brochure.\n* Have a history of allergies, hypersensitivities, or intolerance to the study treatments including any excipients thereof.\n* Have a current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias.\n* Have any known bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.\n* Have a body mass index ≤18.5 kg\u002Fm\\^2 or ≥35 kg\u002Fm\\^2.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",true,"ALL","18 Years","64 Years",{"count":179,"type":180},310,"ESTIMATED","INTERVENTIONAL",[183],"PHASE2","This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.",[186,187,188],"Mpox (Monkeypox)","Smallpox","Orthopoxvirus Infection",[190,191,192],"Monkeypox virus (MPXV)","Active immunization","Ribonucleic acid (RNA) vaccine","2026-08-10",{"date":195,"type":196},"2026-08-11","ACTUAL",{"date":198,"type":196},"2026-02-20",{"date":200,"type":180},"2027-06",{"name":5,"class":6},6]