[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"juvenile-systemic-lupus-erythematosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:juvenile-systemic-lupus-erythematosus":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,61],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":41,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":5},"100599701","phase-4-safety-and-immunogenicity-of-the-live-attenuated-tetravalent-butantan-dengue-vaccine-in-autoimmune-rheumatic-diseases-100599701",false,"NCT07087912","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas","BTNDV-ARD","Inclusion Criteria:\n\n* Age between 12 and 59 years\n* Male or female\n* Clinical diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted criteria (e.g., rheumatoid arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, Sjögren's syndrome, vasculitis)\n* Healthy control matched by age and sex\n* ARD patients with clinically stable disease for at least 3 months\n* ARD patients under low-grade immunosuppression or no immunosuppression\n* Acceptable immunosuppressive treatments include:\n\nHydroxychloroquine Sulfasalazine Prednisone ≤ 20 mg\u002Fday Methotrexate ≤ 0.4 mg\u002Fkg\u002Fweek (maximum 20 mg\u002Fweek) Leflunomide 20 mg\u002Fday Azathioprine \\\u003C 3 mg\u002Fkg\u002Fday Combination therapy with low-dose prednisone (≤ 7.5 mg\u002Fday), hydroxychloroquine, or sulfasalazine\n\n* Healthy controls with no history of autoimmune or chronic infectious diseases\n* Healthy controls not taking immunosuppressive medications Willing and able to comply with study procedures and follow-up\n* Female participants of reproductive potential with negative pregnancy test at baseline\n* Female participants of reproductive potential agreeing to use effective contraception for at least 90 days after vaccination\n\nExclusion Criteria:\n\n* Prior receipt of any dengue vaccine\n* Receipt of a live attenuated vaccine within 4 weeks prior to enrollment\n* Receipt of an inactivated vaccine within 2 weeks prior to enrollment\n* Known allergy to any component of the vaccine\n* Febrile illness (≥ 37.8°C) within 72 hours prior to vaccination\n* History of immunodeficiency syndromes\n* History of asplenia\n* History of cancer\n* History of HIV infection\n* History of primary immunodeficiencies\n* Immunosuppression due to organ transplant\n* Chronic uncontrolled comorbidities (e.g., heart failure, renal failure, hepatic insufficiency, diabetes mellitus)\n* Hospitalization or acute illness at screening\n* Receipt of blood transfusion within 3 months prior to enrollment\n* Current pregnancy or breastfeeding\n* Intention to become pregnant within 90 days post-vaccination\n* Participation in another clinical trial within 30 days prior to enrollment",true,"ALL","12 Years","59 Years",{"count":22,"type":23},477,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age.\n\nThe main questions it aims to answer are:\n\nDoes the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs?\n\nResearchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles.\n\nAll participants will:\n\n* receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection;\n* undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses;\n* attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests;\n* report any symptoms or adverse events using a standardized diary for 42 days;\n* be followed for up to one year for long-term safety and immunogenicity assessments.\n* wear a device for 14 consecutive days to assess current and habitual physical activity levels.\n* answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status.\n* collect blood samples one-year after vaccination to access immunogenicity and cellular response.\n\nResearcher will also perform subgroups analysis in:\n\nA viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration.\n\nAn immunogenicity subgroup (\\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.",[29,30,31,32,33,34,35,36,37,38,39,40],"Rheumatoid Arthritis (RA)","Juvenile Idiopathic Arthritis (JIA)","Systemic Lupus Erythematosus (SLE)","Juvenile Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)","Idiopathic Inflammatory Myopathies (IIMs)","Axial Spondyloarthritis","Psoriatic Arthritis (PsA)","Granulomatosis With Polyangiitis","Microscopic Polyangiitis","Antiphospholipid Syndrome","Takayasu Arteritis",[42,43,44,45,46,47,48],"Tetravalent Vaccine","Butantan-Dengue Vaccine","Autoimmune Rheumatic Diseases","Rheumatology","Pediatric Rheumatology","Infectious Disease Prevention","Vaccine","RECRUITING","2026-04-14",{"date":52,"type":53},"2026-04-15","ACTUAL",{"date":55,"type":23},"2026-03-16",{"date":57,"type":23},"2028-12-30",{"name":59,"class":60},"University of Sao Paulo General Hospital","OTHER",{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100571286","assessment-of-hematologic-indices-in-juvenile-lupus-erythematosus-patientscorrelation-with-disease-activity-and-chronic-organ-damage-in-these-patients-100571286","NCT06718283","Assessment of Hematologic Indices in Juvenile Lupus Erythematosus Patients:Correlation With Disease Activity and Chronic Organ Damage in These Patients","Assessment of Hematologic Indices in Juvenile Lupus Erythematosus Patients : Correlation With Disease Activity and Chronic Organ Damage in These Patients","Inclusion Criteria:\n\n* patients who fillful 2012 SLICC criteria or 2019 ACR\u002FEULAR criteria of systemic lupus erythematosus\n* Age of patients at disease onset before 18 years\n\nExclusion Criteria:\n\n* Adult onset disease ( age at disease onset after 18 years\n* Any other chronic inflamatory disorders or other autoimmune diseases","18 Years",{"count":70,"type":23},50,"OBSERVATIONAL","The study aim to evaluate the relationship between some important hematologic indices in juvenile lupus erythematosus patients and if these indices may be use as markers of disease acitivity in these patients or not ,also evaluate the relationship with these markers and chronic organ damage index",[32],"2024-12-04",{"date":76,"type":53},"2024-12-05",{"date":78,"type":23},"2024-11-30",{"date":80,"type":23},"2026-02-02",{"name":82,"class":60},"Sohag University",1]