[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mpox-monkeypox\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mpox-monkeypox":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,83,115,143],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100638236","assessment-of-immune-memory---humoral-and-cellular---in-mpox-infected-patients--an-ancillary-study-of-the-anrs0258s-mosaic-cohort-100638236",false,"NCT07592429","Assessment of Immune Memory - Humoral and Cellular - in mPOX-infected Patients : an Ancillary Study of the ANRS0258s MOSAIC Cohort","POXAIM","Inclusion Criteria:\n\n* Written informed consent, signed by the participant and the investigator prior to any study-related procedure\n* Person previously enrolled in the ANR0258s-MOSAIC cohort (see Appendix 19.2 for MOSAIC inclusion criteria) between July 2022 and July 2023\n* Person with a blood sample taken within 8 months following mpox infection\n* ≥ 18 years old\n\nExclusion Criteria:\n\n* Individuals who, in the investigator's opinion, are unlikely to comply with study procedures or whose medical condition is incompatible with study participation\n* For France only: person not affiliated to or not benefiting from a social security scheme in accordance with article L1121-11 of the French Public Health Code (Aide Médicale d'Etat \\[AME\\] does not constitute a social security scheme)\n* Pregnant or breastfeeding women\n* Individuals under guardianship or curatorship, or deprived of liberty by judicial or administrative decision","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","Primary objective The overall objective is to assess the long-term amplitude and durability of the immune responses after mpox virus (MPXV) infection.\n\nPrimary endpoint The main outcomes are: the presence of neutralizing antibodies in the serum and the presence of detectable mpox virus-specific memory B cells. Neutralizing antibodies titers will be measured with a semi-automated cell-based assay using live mpox virus. Memory B cells will be measured by flow cytometry and other techniques.\n\nSecondary objectives\n\n1. Assess the amplitude and the stability of the MPXV antigen-specific B-cell memory response after infection, against the immunodominant antigens A27, A33, B5, L1, D8, and H3.\n2. Assess the breadth of the B-cell repertoire and its neutralizing capacity in a subset of patients\n3. Assess the humoral immunity using different serological techniques, for the detection and quantification of anti-MPXV antibodies, and assess the seroneutralization capacities of each antibody.\n\nSecondary endpoints\n\n1. The presence of MPXV antigen-specific B-cell memory. Memory B cells will be measured by flow cytometry and other techniques.\n2. The breadth and neutralizing capacity of the B-cell repertoire in a subset of patients.\n3. The humoral immunity using serological techniques.",[26],"Mpox (Monkeypox)",[28,29,30,31,32],"mpox virus","Immune protection","Immune response","Immunity duration","Infection","NOT_YET_RECRUITING","2026-05-14",{"date":36,"type":37},"2026-05-18","ACTUAL",{"date":39,"type":20},"2026-07-01",{"date":41,"type":20},"2028-07-01",{"name":43,"class":44},"ANRS, Emerging Infectious Diseases","OTHER_GOV",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100634021","understanding-mpxv-viral-clearance-transmission-dynamics-and-mpox-vaccine-effectiveness-in-west-africa--guinea-100634021","NCT07534267","Understanding MPXV Viral Clearance, Transmission Dynamics, and Mpox Vaccine Effectiveness in West Africa : Guinea","Understanding MPXV Viral Clearance in Mpox Patients and Evaluating Transmission Dynamics of MPXV and Mpox Vaccine Effectiveness in West Africa : The Republic of Guinea","MOVIE-TRACE-WA","Inclusion Criteria:\n\n1. MOVIE-West Africa\n\n   * Individuals of any sex and age.\n   * Confirmed Mpox cases who tested positive for MPXV by PCR.\n   * Symptom onset within the 10 days prior to the baseline assessment.\n   * Willingness and ability to comply with study procedures and attend scheduled follow-up visits for up to two months.\n   * Availability for follow-up throughout the study period.\n   * Provision of written informed consent by the participant, or consent by a legally authorized representative for minors or individuals unable to provide it themselves.\n   * Assent obtained from children aged 12 to 17 years.\n   * For individuals who cannot read or write, witnessed consent will be obtained.\n2. TRACE-West Africa\n\n   * Individuals who have had close physical contact with a PCR-confirmed Mpox case within 14 days from the onset of symptoms in the index case.\n   * Close physical contact is defined as being within 2 meters of an infected person-particularly in enclosed spaces-for at least 5 minutes (based on CDC's 2-meter rule for droplet transmission).\n   * Willingness and ability to comply with the study protocol and attend scheduled follow-up assessments.\n   * Provision of written informed consent by the participant, or consent by a legally authorized representative for individuals unable to provide it themselves.\n   * Assent obtained from children aged 12 to 17 years.\n   * For individuals who cannot read or write, witnessed consent will be obtained.\n3. VE-West Africa\n\n   * The inclusion criteria for Mpox cases in VE-West Africa are same as those in MOVIE-West Africa.\n   * The inclusion criteria for contacts of Mpox cases in VE-West Africa are as follows.\n   * Individuals who have had close physical contact with a PCR-confirmed Mpox case within 14 days from the onset of symptoms in the index case.\n   * Close physical contact is defined as being within 2 meters of an infected person-particularly in enclosed spaces-for at least 5 minutes (based on CDC's 2-meter rule for droplet transmission).\n   * Individuals living, working or studying in a community where mpox vaccination is being offered.\n   * Willingness and ability to comply with the study protocol and attend scheduled follow-up assessments.\n   * Provision of written informed consent by the participant, or consent by a legally authorized representative for individuals unable to provide it themselves.\n   * Assent obtained from children aged 12 to 17 years.\n   * For individuals who cannot read or write, witnessed consent will be obtained.\n\nExclusion Criteria:\n\n(1) MOVIE-West Africa\n\n* Cases of severe Mpox requiring hospitalization.\n* Individuals with a confirmed alternative diagnosis explaining their illness.\n\n  (3) VE-West Africa\n* The exclusion criteria for Mpox cases in VE-West Africa are as follows.\n* Cases of severe Mpox requiring hospitalization.\n* Individuals with a confirmed alternative diagnosis explaining their illness.",true,{"count":55,"type":20},992,"56 Days","OBSERVATIONAL","This study has three primary objectives to address the public health challenges of the Mpox outbreak in Guinea, West Africa. Objective 1 (MOVIE-West Africa) focuses on understanding the kinetics of Monkeypox virus (MPXV) elimination from the human body in Mpox cases. Objective 2 (TRACE-West Africa) aims to determine the MPXV transmission dynamics between Mpox cases and their contacts. Objective 3 (VE-West Africa) examines the vaccine effectiveness of the MVA-BN vaccine in protection against MPXV infection and Mpox disease.",[26,60],"Monkeypox",[62,60,63,64,65,66,67,68,69,70,71,72],"Mpox","MPXV","transmission dynamics","vaccine effectiveness","secondary attack rate","MVA-BN","Guinea","sub-Saharan Africa","West Africa","MOVIE-TRACE","viral clearance","2026-04-10",{"date":75,"type":37},"2026-04-16",{"date":75,"type":20},{"date":78,"type":20},"2027-08",{"name":80,"class":81},"London School of Hygiene and Tropical Medicine","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"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","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.","64 Years",{"count":92,"type":20},310,[94],"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.",[26,97,98],"Smallpox","Orthopoxvirus Infection",[100,101,102],"Monkeypox virus (MPXV)","Active immunization","Ribonucleic acid (RNA) vaccine","RECRUITING","2026-03-02",{"date":106,"type":37},"2026-03-04",{"date":108,"type":37},"2026-02-20",{"date":110,"type":20},"2027-06",{"name":112,"class":113},"BioNTech SE","INDUSTRY",6,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":53,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":126,"studyType":57,"phases":4,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":82},"100600130","evaluation-of-effectiveness-and-safety-of-lc16m8-mpox-vaccine-in-the-democratic-republic-of-congo-drc-100600130","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.","1 Year",{"count":125,"type":20},11990,"12 Weeks","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.",[26,62],[130,62,131,132,133],"LC16m8","Effectiveness","Safety","DRC","2025-09-08",{"date":136,"type":37},"2025-09-15",{"date":138,"type":20},"2025-09-30",{"date":140,"type":20},"2027-12-31",{"name":142,"class":81},"International Vaccine Institute",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":151,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100580661","diagramie-mpox-virus-rdc-for-the-diagnostic-of-monkeypox-100580661","NCT06840197","DiagRaMIE Mpox Virus-RDC for the Diagnostic of Monkeypox","Evaluation of Rapid Diagnostic Solutions for Emerging Infectious Diseases and CBRN Threats - Mpox Virus Clinical Study in the Democratic Republic of the Congo - DiagRaMIE-Mpox Virus-DRC","DiagRaMIE Mpox","Inclusion Criteria:\n\n* Any person showing signs and symptoms, vesicles, and pustules consistent with the WHO definition of suspected Mpox cases (https:\u002F\u002Fwww.who.int\u002Ffr\u002Fpublications-detail\u002FWHO-MPX-Surveillance-2022.3)\n* Persons aged 2 years and older:\n* An adult capable of providing informed consent to participate in the study\n* The legal guardian(s) capable of providing informed consent for the minor's participation in the study. For minors aged 12 to 17, their assent will also be required\n\nExclusion Criteria:\n\n* Refusal to participate by the individual or their legal guardian(s)\n* Person not capable of giving informed consent\n* Person with symptoms that appeared more than 14 days ago\n* Person presenting only with macules, papules, and crusts","2 Years",{"count":153,"type":20},197,"Monkeypox, caused by a virus in the Orthopoxvirus genus, is a zoonotic disease first identified in 1970 in the Democratic Republic of Congo (DRC). This infection, primarily present in Central and West Africa, has an incubation period of 6 to 21 days and initially presents with fever, headaches, muscle pain, and swollen lymph nodes. This is followed by a skin rash that evolves over 2 to 3 weeks. Lesions can spread from the face to the hands, feet, and mucous membranes, with a centrifugal distribution pattern. Diagnosis is performed using PCR, based on samples taken from lesions or cutaneous exudates, although oropharyngeal swabs may be required if skin lesions are absent.\n\nSince May 2022, a resurgence of cases has been observed in North America, Europe, and Africa, including the DRC. As of March 2024, 94,270 cases and 178 deaths have been reported. Although less lethal than smallpox, with a mortality rate of 1% to 10% depending on the region, monkeypox remains a health threat, especially for young children and immunocompromised individuals. In response, the Commissariat à l'Énergie Atomique (CEA) and NG Biotech have developed the NG-TestⓇ Monkeypox virus rapid diagnostic test to facilitate detection. This antigenic immunochromatographic test, based on clinical samples, offers an alternative to PCR, providing rapid results without the need for costly equipment or specialized expertise. Its validation is underway for CE marking, enabling a swift response to potential health crises.\n\nPreclinical trials have confirmed that this test detects the Mpox virus with a detection limit of 1.10⁴ pfu\u002FmL and shows no cross-reaction with other common organisms. This clinical performance study aims to determine the effectiveness of this device using prospectively collected clinical samples. The study seeks to validate this rapid diagnostic test (RDT) and support its CE marking. Thus, this test could serve as an alternative to conventional PCR diagnostics, which require several hours to process and necessitate costly specialized equipment and expertise.",[26,156],"Monkeypox Virus Infection",[62,158,159],"Monkeypox virus","Rapid Diagnostic Test (RDT)","2025-02-17",{"date":162,"type":37},"2025-02-21",{"date":164,"type":20},"2025-02",{"date":166,"type":20},"2025-05",{"name":168,"class":81},"Assistance Publique - Hôpitaux de Paris",3]