[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"monkey-pox\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:monkey-pox":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,36,73,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":4},"100637081","performance-evaluation-of-mpox-molecular-poc-diagnostics-100637081",false,"NCT07620600","Performance Evaluation of Mpox Molecular POC Diagnostics","Clinical Performance Evaluation of Novel Rapid Molecular Point-of-care (POC) Diagnostics for Mpox Virus","Inclusion Criteria:\n\n* Lesion swabs stored in VTM\u002FUTM (non-inactivating)\n* Aliquot with sufficient volume to run the reference PCR and at least one index test (≥2600 μL per pair reference-index tests: ideally at least 1400 μL for 3 index tests and 1200 μL for reference PCR, including 1 possible repeat per test)\n* Available PCR result for specimen selection (i.e. confirmed MPXV positive or negative)\n* Samples collected from 2020 onwards.\n\nExclusion Criteria:\n\n* Unknown date of collection\n* \\>3 freeze-thaw cycles of sample.\n* Samples collected with expired swab collection devices or UTM\u002FVTM","ALL",{"count":18,"type":19},80,"ESTIMATED","OBSERVATIONAL","PP016 is a FIND-sponsored retrospective clinical performance study evaluating rapid molecular point-of-care (mPOC) tests for the detection of Mpox virus (MPXV) using archived lesion swab specimens collected in Uganda. Conducted at the Central Public Health Laboratory (CPHL) in Kampala, the study compares up to three investigational assays-Genes2Me VZV-Q, KH Medical RADI-ONE Mpox, and SD Biosensor STANDARD M10 MPX\u002FOPX-against the BioPerfectus laboratory PCR reference test. The primary objective is to determine the sensitivity and specificity of each assay for detecting MPXV in archived positive and negative samples, while secondary analyses assess performance by Ct value and viral clade. The study uses a blinded, non-interventional case-control design with de-identified specimens collected since 2020. Approximately 80 samples per device evaluation are included. PP016 was initiated in response to ongoing mpox outbreaks and the need for accurate decentralized diagnostics in low-resource settings. The study complies with ISO 20916, ICH-GCP principles where applicable, and Ugandan ethical and regulatory requirements, with findings expected to support future regulatory approvals and implementation of rapid mpox diagnostics in low- and middle-income countries",[23],"Monkey Pox","NOT_YET_RECRUITING","2026-05-27",{"date":27,"type":28},"2026-06-02","ACTUAL",{"date":30,"type":19},"2026-06-15",{"date":32,"type":19},"2026-09-15",{"name":34,"class":35},"Foundation for Innovative New Diagnostics, Switzerland","OTHER",{"id":37,"slug":38,"hasResults":11,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":57,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100599524","neutralizing-power-of-serum-antibodies---2-100599524","NCT07085611","Neutralizing Power of Serum Antibodies - 2","Study of the Neutralizing Power of Serum Antibodies - 2 (PNAS-2)","PNAS-2","Inclusion Criteria:\n\n* Adults (≥18 years)\n* Patients receiving or scheduled to receive anti-SARS-CoV-2 and\u002For anti-MPXV vaccines or monoclonal antibodies\n* Patients have provided written informed consent\n\nExclusion Criteria:\n\n* Persons under guardianship or curatorship\n* Persons under legal protection,\n* Persons persons deprived of liberty\n* Persons not affiliated to a social security scheme\n* Pregnant or breastfeeding women","18 Years",{"count":46,"type":19},30,"INTERVENTIONAL",[49],"NA","Severe forms of COVID-19 and Monkeypox affect immunocompromised and comorbid individuals. Vaccination and monoclonal antibody therapies induce neutralizing antibodies. This neutralizing power is recognized as a correlate of protection against a new infection. This study aims to describe the neutralizing power of serum and nasal antibodies over time, in relation to SARS-CoV-2 and MPXV vaccines or treatments received.",[52,53,23,54,55,56],"COVID-19","SARS-CoV-2 Viraemia","Vaccination","Serum","Mucosal Immunity",[58,59,60,54,55,61],"Neutralizing antibodies","SARS-CoV-2","Monkeypox","Mucosal immunity","RECRUITING","2025-12-12",{"date":65,"type":28},"2025-12-19",{"date":67,"type":28},"2025-08-22",{"date":69,"type":19},"2035-07-11",{"name":71,"class":35},"Centre Hospitalier Régional d'Orléans",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100550087","observational-mondkeypox-pregnancy-cohort-100550087","NCT06442501","Observational Mondkeypox Pregnancy Cohort","Pregnancy Monkeypox Cohort Study in the South Kivu Province in the DRC","PREGMPOXCO","Inclusion Criteria:\n\n* 1\\. Pregnancy status: all women confirmed to be pregnant at the time of recruitment.\n\n  2\\. Age: women of all age (ascent to be asked for non-legal age to allow for the pair mother-child to benefit with earlier diagnosis and other befit the study might offer).\n\n  3\\. Geographical inclusion: residing within the catchment areas of the selected healthcare facilities in South Kivu to ensure that they are likely to continue receiving follow-up care at the participating sites throughout their pregnancy.\n\n  4\\. Symptomatic and asymptomatic participation:\n  * Symptomatic: pregnant women presenting with symptoms suggestive of mpox, such as fever, rash\u002Fskin lesion, or lymphadenopathy.\n  * Asymptomatic: pregnant women attending routine antenatal visits who do not exhibit symptoms but are screened as part of the study's surveillance efforts or who report a confirmed case of mpox in the household\u002For among closed contacts 5. Consent: women who provide written informed consent to participate in the study, having understood the purpose, procedures, potential risks, and benefits of the study.\n\nExclusion Criteria:1. Non-consent: pregnant women who do not consent\u002For their parent-caregiver to participate in the study.\n\n2\\. Medical exclusions: women with pre-existing medical conditions that, as determined by clinical judgment, may either put them at risk due to participation in the study or could confound the study results (e.g., conditions that significantly alter immune response such as confirmed cancer).\n\n3\\. Plans to relocate: women who plan to move out of the geographical study area during the study period, which would interfere with follow-up.\n\n4\\. Participation in other studies: women currently participating in other clinical trials that might interfere with the results of this study, especially trials involving new experimental treatments for mpox or other infectious diseases.\n\n\\-",true,"FEMALE",{"count":84,"type":19},150,"PREGMPOXCO study addresses the escalating Mpox virus (MPXV) infections among pregnant women in South Kivu, DRC following a novel MPXV sub-lineage, predominantly transmitted through heterosexual contact, stressing critical gaps in our understanding of MPXV's impact on pregnant populations. To better understand this altered transmission pattern of MPXV and its impact on this vulnerable population, PREGMPOX will employ both passive and active surveillance techniques to methodologically capture MPXV incidence among pregnant women over two years, integrating data from routine antenatal care and targeted community outreach to timely assess the MPXV's effects on maternal and neonatal health. In sentinel study sites in hot spot areas, the incidence of mpox among pregnant women will be investigated and potential transmission routes determined. MPXV(+) pregnant women will be asked to participate in a cohort study where they will be followed until delivery to document pregnancy outcomes (e.g.: miscarriage, stillbirths, preterm deliveries, neonatal mpox), maternal immune response, virus abundance and pathological changes in the placenta. This will help to determine specific risk factors and modes and frequencies of vertical transmission to the unborn, and generate a list of clinical and immunological predictors for adverse outcomes for pregnant women and neonates. Data on MVA-BN exposure will also be captured to report on its real world effectiveness. As a prerequisite to evaluate the safety of the MVA-BN vaccine and tecovirimat treatment in pregnant women according to the new DRC guidelines, we will establish a comprehensive register of adverse pregnancy outcomes, using a pharmacovigilance model to monitor and analyse adverse events following immunization and treatment. The results of our multidisciplinary studies will be crucial for developing guidelines and recommendations to manage mpox more effectively during pregnancy, and for potentially influencing global health policies.",[23],"2024-05-29",{"date":89,"type":28},"2024-06-04",{"date":91,"type":19},"2024-10-01",{"date":93,"type":19},"2027-02-01",{"name":95,"class":35},"Robert Colebunders",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":81,"sex":16,"minAge":44,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":47,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":72},"100487486","clinical-and-biological-aspects-of-the-monkeypox-disease-100487486","NCT05627713","Clinical and Biological Aspects of the MONKEYPOX Disease","Description of the Kinetics of the Clinical and Biological Aspects of the Persons Consulting in the Framework of the Management of the MONKEYPOX Disease","PoxVac22","Inclusion Criteria:\n\n* Adult,\n* eligible for MPXV vaccination according to HAS criteria or suspected of MPXV infection\n* whose health status is compatible with a 45 ml single blood sample\n* who have consented to participate in the study\n* who are covered by a Social Health Insurance plan\n\nExclusion Criteria:\n\n* Person with MPXV vaccination without proof of vaccination.\n* For persons presenting for MPXV vaccination: presence of a contraindication to vaccination other than a current infection.\n* Pregnant and lactating women\n* Person unable to give informed consent to participate",{"count":105,"type":19},330,[49],"Monkey pox virus (MPXV), of the genus Orthopoxvirus, regularly causes epidemics in endemic areas of central and western Africa.\n\nSince January 1, 2022, cases of Monkey pox have been reported to WHO by 96 Member States in the 6 WHO regions. As of 22 August 2022, a total of 41,664 laboratory-confirmed cases and 192 probable cases, including 12 deaths, have been reported to WHO. Since May 13, 2022, a high proportion of these cases have been reported from countries where monkey pox transmission had not previously been documented. For the first time, cases and sustained chains of transmission are being reported in countries without direct or immediate epidemiological links to areas in West or Central Africa (WHO 2022). France is one of the most affected countries with 2889 cases reported as of August 22, 2022.\n\nThis situation led the WHO Director General to declare, on July 23, 2022, that the monkeypox epidemic currently affecting several countries constitutes a Public Health Emergency of International Concern.\n\nTo address this epidemic, the WHO has recommended Post Exposure Vaccination (PEP) and Pre Exposure Vaccination (PrEP) for at risk groups with 2nd and 3rd generation vaccines. In France, the Haute Autorité de Santé (French National Authority for Health) recommended on May 20, 2022, vaccination for PEP and on July 7, 2022, for PrEP with a 3rd generation MVA-BN vaccine (Imvanex® or Jynneos®). The European Medicines Agency (EMA) has approved the use of Imvanex® on July 22, 2022 for immunization against MPXV.\n\nThe objective of the present study is to describe the clinical, biological, virological, pathophysiological and immunological aspects in the short and medium term of persons vaccinated against and infected with MPXV.",[23],[110,111,112,113,114],"vaccination","infection","monkey pox virus","outbreak","immunization","2023-12-18",{"date":117,"type":28},"2023-12-19",{"date":119,"type":28},"2022-12-01",{"date":121,"type":19},"2026-12-01",{"name":123,"class":124},"Institut Pasteur","INDUSTRY"]