[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600130":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":34,"locations":44,"responsibleParty":71,"collaborators":73,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":10,"enrollmentInfo":90,"targetDuration":93,"studyType":94,"phases":10,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":103,"whyStopped":10,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"International Vaccine Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort Event Monitoring (CEM) - Safety cohort",null,"At enrollment\u002Fvaccination visit, participants will be consecutively invited to be enrolled in the safety subset until the sample size of 10,000 has been achieved. The enrollment aims to include a proportional number of participants from various age groups, including 1-5 years, 6-12 years and 13-18 years, with representation from both sexes. The participation will be strictly voluntary according to the eligibility criteria.\n\nEnrolled vaccinees will be actively followed up through phone calls\u002Fhome visits\u002FHealth facility visits for the SAEs and AESIs assessment at weekly intervals for the first month and then at monthly intervals until 12 weeks post vaccination. Vaccinees\u002Fparents\u002Fguardians will be advised to return to the sentinel health facility if any serious event occurs at any time.",[13],"Biological: LC16m8",{"label":15,"type":10,"description":16,"interventionNames":10},"Vaccine Effectiveness (VE) Assessment","Health facility-based enhanced mpox surveillance will be implemented to record mpox cases within the vaccination catchment area. The study will be done in 2 or more health zones identified as hot spots by the DRC government. All patients presenting with probable or suspected mpox to the surveillance healthcare facilities will be approached for testing and enrollment into the surveillance study.\n\nVaccine effectiveness will be estimated using cases and controls assembled based on specific inclusion\u002Fexclusion criteria. A total of 1,990 participants (398 cases and 1,592 controls) will be required for assessment of vaccine effectiveness.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"BIOLOGICAL","LC16m8","LC16m8 vaccine will be offered to all individuals aged \\>1 year and meet the inclusion criteria within the catchment population. This will be done in line with the DRC government's LC16m8 vaccine roll out plan.",[9],[24,28,31],{"name":25,"affiliation":26,"role":27},"Jean Jacques Muyembe","Institut National de la Recherche Biomédicale","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":27},"Norio Ohmagari","Japan Institute for Health Security",{"name":32,"affiliation":5,"role":33},"Florian Marks","STUDY_CHAIR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Birkneh Tilahun Tadesse, MD","CONTACT","+821098041348","birkneh.tadesse@ivi.int",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},"Meseret Behute, MD","+82129732401","Meseret.Behute@ivi.int",[45],{"facility":46,"status":10,"city":47,"state":10,"zip":10,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"The Institut National de la Recherche Biomédicale (INRB)","Kinshasa","Democratic Republic of the Congo","CD",{"type":51,"coordinates":52},"Point",[53,54],15.31357,-4.32758,{"lat":54,"lon":53},[57,61,65,67,69],{"name":58,"role":37,"phone":59,"phoneExt":10,"email":60},"Hugo Kavunga, MD","+243823875153","hugokavunga@gmail.com",{"name":62,"role":37,"phone":63,"phoneExt":10,"email":64},"Pierre Nsele Mutantu, Diploma of Medical Doctor","+243812576722","pierremutantu@gmail.com",{"name":58,"role":66,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":68,"role":66,"phone":10,"phoneExt":10,"email":10},"Pierre Mutantu, Diploma of Medical Doctor",{"name":70,"role":66,"phone":10,"phoneExt":10,"email":10},"Tresor Bodjick, MD",{"type":72,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[74,77],{"name":75,"class":76},"Japan Institute for Health Secutiry","OTHER_GOV",{"name":78,"class":6},"Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo","100600130","evaluation-of-effectiveness-and-safety-of-lc16m8-mpox-vaccine-in-the-democratic-republic-of-congo-drc-100600130",false,"NCT07093489","Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)","Evaluation of the Effectiveness and Safety of the LC16m8 Mpox Vaccine in Individuals Aged One Year and Older in the Democratic Republic of Congo (DRC)","MPX-001","1. Vaccination:\n\n   Inclusion criteria\n   * Individuals aged 12 months and above\n   * Living in the study catchment area\n   * Written informed consent\u002Fassent (if applicable)\n\n   Exclusion criteria\n   * Prior receipt of any mpox vaccine dose\n   * Women known to be pregnant or breast feeding\n   * Individuals suffering from any spreading skin disease\n   * Immunocompromised individuals with known severe immuno-deficiency conditions (example, HIVAIDS, individuals being on chronic use of systemic steroids (\\>2 mg\u002Fkg\u002Fday or \\>20 mg\u002Fday prednisolone equivalent for periods exceeding 10 days, cytotoxic or other immunosuppressive drugs)\n   * Individuals with known underlying uncontrolled chronic diseases such as diabetes mellitus, cardiovascular disease, renal disease, hepatic disease, hematological disease, and developmental disturbance\n   * Individuals with a history of hypersensitivity caused by a component of the vaccine\n\n   Temporary exclusion criteria\n   * Individuals with objective fever (Frontal temperature ≥ 38.5°C) or axillary temperature \\> 37.5 °C\n   * Individuals suffering from acute illness within 48 hours prior to vaccination and based on investigator judgement.\n   * Receipt of any live vaccine injection within the previous 27 days (measles vaccine, rubella vaccine, mumps vaccine, varicella vaccine, BCG vaccine, yellow fever vaccine...).\n2. Cohort Event Monitoring (CEM):\n\n   Inclusion criteria\n   * Written informed consent\n   * Individual who receives single dose of LC16m8 vaccine at one of the vaccination centers participating in the study.\n   * Must be reachable by phone (must have an active phone number of his\u002Fher own or in the household) throughout study participation.\n\n   Exclusion criteria\n\n   • Individual\u002Fparent\u002Fguardian unable to comply with the study procedures\n3. Mpox surveillance (VE):\n\nGeneral Inclusion Criteria:\n\n* Patients (with any vaccination status) presenting to a sentinel surveillance health facility with clinical signs and symptoms consistent with mpox disease (probable or suspected)\n* Reside in the study area prior to testing.\n* Eligible to receive LC16m8 vaccine during the vaccination.\n* Give consent\u002Fassent (if applicable) to participate in the study.\n\nExclusion Criteria\n\n* Individuals meeting any of the following criteria are not eligible for testing and enrollment in the study:\n* Known contraindications for LC16m8 vaccine.\n* As per the Investigator's medical judgement, an individual could be excluded from the study despite meeting all the inclusion\u002Fexclusion criteria mentioned above.",true,"ALL","1 Year",{"count":91,"type":92},11990,"ESTIMATED","12 Weeks","OBSERVATIONAL","This is a health facility-based prospective test-negative (TND) case-control study to evaluate vaccine effectiveness and active safety monitoring (cohort event monitoring), and passive surveillance for evaluation of the safety of the LC16m8 mpox vaccine in individuals aged one year and older in the DRC.\n\nThis study aims to assess the LC16m8 vaccine effectiveness and safety. The following activities will be carried out:\n\n* Community engagement\n* Enhanced health facility-based mpox disease surveillance\n* Vaccination using the LC16m8 vaccine\n* Safety monitoring following immunization\n* LC16m8 Vaccine effectiveness evaluation using a TND\n\nStudy Hypothesis: The LC16m8 vaccine, administered as pre-exposure prophylaxis, confers greater than 70% protection against symptomatic mpox disease among adults and children in the DRC.",[97,98],"Mpox (Monkeypox)","Mpox",[20,98,100,101,102],"Effectiveness","Safety","DRC","NOT_YET_RECRUITING","2025-09-08",{"date":106,"type":107},"2025-09-15","ACTUAL",{"date":109,"type":92},"2025-09-30",{"date":111,"type":92},"2027-12-31",{"name":5,"class":6},1]