[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622127":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":44,"centralContacts":48,"locations":55,"responsibleParty":108,"collaborators":110,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":39,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":39,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":135,"overallStatus":88,"whyStopped":39,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"BioNTech SE","INDUSTRY",[8,14,18,24,27,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 - BNT166a Dose Level (DL) 1 (Orthopoxvirus-naïve participants, aged 18-45 years)","EXPERIMENTAL","Two doses of investigational medicinal product (IMP).",[13],"Biological: BNT166a",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 1 - BNT166a DL 2 (Orthopoxvirus-naïve participants, aged 18-45 years)","Two doses of IMP.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Cohort 1 - Placebo (Orthopoxvirus-naïve participants, aged 18-45 years)","PLACEBO_COMPARATOR","0.9% sodium chloride solution. Two doses of IMP.",[23],"Other: Placebo",{"label":25,"type":10,"description":16,"interventionNames":26},"Cohort 2 - BNT166a DL 1 (Orthopoxvirus-experienced participants, aged 18-64 years)",[13],{"label":28,"type":10,"description":16,"interventionNames":29},"Cohort 2 - BNT166a DL 2 (Orthopoxvirus-experienced participants, aged 18-64 years)",[13],{"label":31,"type":20,"description":21,"interventionNames":32},"Cohort 2 - Placebo (Orthopoxvirus-experienced participants, aged 18-64 years)",[23],[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"BIOLOGICAL","BNT166a","Intramuscular injection. Injections should be given in the deltoid muscle, using the same non-dominant arm for all IMP doses.",[15,9,25,28],null,{"type":41,"name":42,"description":37,"armGroupLabels":43,"otherNames":39},"OTHER","Placebo",[19,31],[45],{"name":46,"affiliation":5,"role":47},"BioNTech Responsible Person","STUDY_DIRECTOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},"BioNTech clinical trials patient information","CONTACT","+49 6131 9084","0","patients@biontech.de",[56,69,75,86,93,99],{"facility":57,"status":58,"city":59,"state":39,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":39},"University of Kinshasa UNIKIN","NOT_YET_RECRUITING","Kinshasa","01306","Democratic Republic of the Congo","CD",{"type":64,"coordinates":65},"Point",[66,67],15.31357,-4.32758,{"lat":67,"lon":66},{"facility":70,"status":58,"city":59,"state":39,"zip":71,"country":61,"countryCode":62,"cosmosGeoPoint":72,"geoPoint":74,"contacts":39},"Institute National de Recherche 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Research Unit","Johannesburg","1864",{"type":64,"coordinates":104},[105,106],28.04363,-26.20227,{"lat":106,"lon":105},{"type":109,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[111],{"name":112,"class":41},"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":125,"type":126},310,"ESTIMATED","INTERVENTIONAL",[129],"PHASE2","This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, 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