[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"smallpox\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:smallpox":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":21,"type":22},310,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Mpox (Monkeypox)","Smallpox","Orthopoxvirus Infection",[32,33,34],"Monkeypox virus (MPXV)","Active immunization","Ribonucleic acid (RNA) vaccine","RECRUITING","2026-03-02",{"date":38,"type":39},"2026-03-04","ACTUAL",{"date":41,"type":39},"2026-02-20",{"date":43,"type":22},"2027-06",{"name":45,"class":46},"BioNTech SE","INDUSTRY",6,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100621942","phase-1-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-bsy001-after-singlemultiple-doses-100621942","NCT07377175","Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single\u002FMultiple Doses.","A Two-Phase, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 for Injection Following Single or Multiple Doses in Healthy Subjects.","Inclusion Criteria:\n\n1. Subjects voluntarily participate in the study, sign the informed consent form, and agree to comply with all study requirements;\n2. Aged ≥ 18 years and ≤ 50 years (based on the date of signing the informed consent form), including both males and females;\n3. Body Mass Index (BMI) between 19.0 and 30.0 kg\u002Fm² (19.0 and 30.0 kg\u002Fm² inclusive); for female subjects, body weight between 45.0 and 120.0 kg (45.0 kg inclusive and 120.0 kg exclusive); for male subjects, body weight between 50.0 and 120.0 kg (50.0 kg inclusive and 120.0 kg exclusive);\n4. Subjects (including their partners) voluntarily adopt effective contraceptive measures from 1 month before screening to 6 months after the last administration of the study drug, and have no plans for childbearing, sperm donation, or egg donation within the next 6 months.\n\nExclusion Criteria:\n\n1. Subjects with a known allergy to Tecovirimat drugs, any excipient ingredients in this product, or subjects with an allergic diathesis (allergic to ≥ 2 types of substances);\n2. Subjects with clinically significant abnormal electrocardiogram (ECG) findings or QTc prolongation as determined by the investigator (e.g., QTc interval ≥ 450 ms in males and ≥ 470 ms in females, with QTc interval calculated using the Fridericia formula);\n3. Subjects with a creatinine clearance rate (Cockcroft-Gault formula) \\\u003C 90 mL\u002Fmin;\n4. Subjects with clinically significant abnormalities in physical examination, vital signs, laboratory tests, or other auxiliary examinations as determined by the investigator;\n5. Subjects with current or past history of the following clinically significant diseases as determined by the investigator, including but not limited to diseases of the cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, immune system, and nervous system (e.g., epilepsy);\n6. Subjects with a current or history (within the past 3 months) of bacterial, fungal, or mycobacterial infection.;\n7. Subjects with known clinically significant acute\u002Fchronic viral infections;\n8. Subjects with a history of severe headache or migraine;\n9. Subjects who have undergone major surgery within 6 months before drug administration, or plan to undergo surgery from the time of signing the informed consent form to 1 month after the end of the trial;\n10. Subjects who have donated blood or had massive blood loss (\\> 450 mL) within 3 months before screening;\n11. Subjects who smoked more than 5 cigarettes per day within 3 months before signing the informed consent form, or cannot refrain from using any tobacco products during the trial;\n12. Subjects who consumed more than 14 units of alcohol per week within 3 months before signing the informed consent form (1 unit of alcohol ≈ 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine), had a positive alcohol breath test (breath alcohol content \\> 0 mg\u002F100 mL), or cannot abstain from alcohol during the trial;\n13. Subjects who consumed grapefruit, grapefruit juice, chocolate, strong tea, coffee, or other beverages containing caffeine or alcohol within 72 hours before drug administration, or refuse to stop consuming the aforementioned beverages and foods during the trial;\n14. Subjects who plan to engage in strenuous exercise during the trial, including contact sports or collision sports;\n15. Subjects with a positive urine drug screen (for morphine, methamphetamine, ketamine, 3,4-methylenedioxymethamphetamine, or tetrahydrocannabinolic acid), or a history of drug abuse or drug use within 5 years before screening;\n16. Subjects with a positive result in any of the following tests: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (IgG), hepatitis C virus core antigen, human immunodeficiency virus (HIV) antibody, or treponema pallidum-specific antibody (TP-Ab);\n17. Subjects who participated in other drug clinical trials within 3 months before screening (calculated starting from the time of the last drug administration in the previous trial);\n18. Subjects who took any prescription drugs, over-the-counter drugs, or traditional Chinese herbal medicines within 30 days before screening;\n19. Subjects with a positive pregnancy test result;\n20. Subjects who cannot tolerate venipuncture, or have a history of hematophobia (fear of blood) or trypanophobia (fear of needles);\n21. Subjects who developed an acute illness or required concomitant medication from the screening phase to before the first drug administration;\n22. Subjects who received a vaccine within 2 weeks before screening, or plan to receive a vaccine during the trial;\n23. Subjects deemed unsuitable for participation in this trial by the investigator.","50 Years",{"count":57,"type":22},76,[59],"PHASE1","A Two-Phase, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 for Injection Following Single or Multiple Doses in Healthy Subjects",[29,62,63,64],"Cowpox","Monkeypox","Poxvirus Infection","2026-01-22",{"date":67,"type":39},"2026-01-29",{"date":69,"type":39},"2025-08-28",{"date":71,"type":22},"2026-02-13",{"name":73,"class":46},"China National Biotec Group Company Limited",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":89,"locationsCount":4},"100215367","tecovirimat-st-246-treatment-for-orthopox-virus-exposure-100215367","NCT02080767","Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure","Clinical Protocol to Treat Individuals With Tecovirimat (ST-246) After Exposure to Orthopox Viruses","Inclusion Criteria:\n\n* DoD-affiliated personnel (including US civilian employees, contractors and other US personnel and dependents, as well as allied military forces and local nationals) of any age, not breastfeeding\n* Has been exposed to or infected with orthopox viruses (ie, variola (smallpox), vaccinia, monkeypox, or cowpox) OR Has developed serious complications from vaccinia vaccination (eg, eczema vaccinatum, progressive vaccinia, generalized vaccinia that is severe or persistent, and select cases of inadvertent inoculation due to severe pain related to mucosal involvement, ocular involvement) resulting from vaccination, secondary transmission, or other exposure\n* Is available for clinical follow-up for duration of the treatment and follow-up period\n* Must be able to swallow capsules\n\nExclusion Criteria:\n\n* Has hypersensitivity to tecovirimat\n* Unable or unwilling to cooperate with the requirements of the treatment protocol\n* Breast-feeding patients. Note that breast-feeding females will be counseled that tecovirimat has not been studied in breast-feeding women and may opt to cease breast-feeding for the duration of the treatment and at least 30 days after the last dose of drug and thus be eligible for enrollment. Women who choose to continue breast-feeding will not be enrolled in this treatment protocol.","EXPANDED_ACCESS","The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthopox viruses.",[29,63],"AVAILABLE","2025-03-05",{"date":88,"type":39},"2025-03-06",{"name":90,"class":91},"U.S. Army Medical Research and Development Command","FED"]