[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaccine-adverse-reaction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaccine-adverse-reaction":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,87,115,142],{"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":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100455609","genomics-and-covid-19-vaccine-adverse-events-100455609",false,"NCT05212792","Genomics and COVID-19 Vaccine Adverse Events","Genomics of COVID-19 Vaccine-induced Adverse Events (Guillain-Barré Syndrome [GBS], Vaccine-induced Immune Thrombotic Thrombocytopenia [VITT]\u002FThrombosis With Thrombocytopenia Syndrome [TTS], and Myocarditis\u002FPericarditis)","Inclusion Criteria:\n\n* Case: Any patient who received COVID-19 vaccines and developed GBS, VITT\u002FTTS, or myocarditis\u002Fpericarditis after vaccination\n* Control: Any participant who received COVID-19 vaccines and does not experience GBS, VITT\u002FTTS, or myocarditis\u002Fpericarditis.\n\nExclusion Criteria:\n\n* Individuals who have not received a COVID-19 vaccine\n* Individuals who are unable to provide informed consent",true,"ALL","5 Years","99 Years",{"count":21,"type":22},6325,"ESTIMATED","OBSERVATIONAL","Vaccines routinely used are extremely safe; however, severe adverse events to vaccines do occur. As vaccination against COVID-19 has begun, adverse events to the vaccine, particularly Guillain-Barré syndrome (GBS), vaccine-induced immune thrombotic thrombocytopenia (VITT)\u002Fthrombosis with thrombocytopenia syndrome (TTS), and myocarditis\u002Fpericarditis, after COVID-19 vaccination have been reported worldwide.\n\nStudy hypothesis: there are genetic factors that contribute to increased risks of particular COVID-19 vaccine-induced adverse events.\n\nThe objective of the study is to determine if there are specific genetic factors strongly associated with each of the COVID-19 vaccine-induced adverse events (i.e., GBS, VITT\u002FTTS, and myocarditis\u002Fpericarditis).",[26],"Vaccine Adverse Reaction",[28,29,30,31,32,33,34],"Genomics","COVID-19 vaccine adverse event","Guillain-Barré syndrome (GBS)","Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT)","Thrombosis with thrombocytopenia syndrome (TTS)","Myocarditis","Pericarditis","RECRUITING","2026-04-27",{"date":38,"type":39},"2026-05-01","ACTUAL",{"date":41,"type":39},"2022-06-24",{"date":43,"type":22},"2026-12",{"name":45,"class":46},"University of British Columbia","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":16,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":47},"100598966","phase-1-clinical-trial-phase-iiia-to-evaluate-the-safety-and-immunogenicity-of-streptincor-100598966","NCT07078357","Clinical Trial Phase I\u002FIIa to Evaluate the Safety and Immunogenicity of StreptInCor","Phase I\u002FIIa Clinical Trial to Evaluate the Safety and Immunogenicity of StreptInCor, a Synthetic Vaccine Against Streptococcus Pyogenes, in Healthy Adult Volunteers.","StreptInCorVac","Inclusion Criteria:\n\n* • Healthy male or female volunteers, aged between 18 and 45 years;\n\n  * Availability to undergo all procedures throughout the study period;\n  * Provide free and informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Participation in clinical trials within the last year\n* Participation in cohort studies\n* Diagnosis of concomitant infections or diseases that may affect immunity, including active HIV infection, hepatitis B, hepatitis C, diabetes mellitus, neoplasms, and autoimmune diseases;\n* Current or previous diagnosis or family history of ARF, chorea, obsessive-compulsive disorder, or glomerulonephritis;\n* Current or previous diagnosis of heart diseases;\n* Severe asthma or chronic obstructive pulmonary disease (COPD);\n* Abnormal neurological clinical assessment, especially chorea;\n* Use of treatments that may affect immunity in the last four weeks, including immunomodulators, corticosteroids (only systemic use for two weeks or more), or antineoplastic agents;\n* Use of treatments that may affect heart valves in the last four weeks or planned during the study period, including fenfluramine and dexfenfluramine;\n* Renal insufficiency determined by estimated creatinine clearance below 45 ml\u002Fmin\u002F1.73m²;\n* History of intolerance or allergy to any component of the study product, including antigen or adjuvant;\n* Presence of valve abnormalities or alterations in cardiac anatomy as defined by echocardiogram;\n* Altered electrocardiogram;\n* Evidence or suspicion of recent S. pyogenes infection based on clinical symptoms in the last four weeks;\n* Pregnancy, breastfeeding mother, or intention to become pregnant during the study period (only female participants);\n* Any other condition that may interfere with the study process as assessed by the researchers, including sample size and statistical power.","18 Years","45 Years",{"count":59,"type":22},60,"INTERVENTIONAL",[62,63],"PHASE1","PHASE2","This is a Phase I\u002FIIa, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to test the candidate vaccine StreptInCor. The study will include four different doses (25 µg, 50 µg, 100 µg, and 200 µg) of StreptInCor produced under Good Manufacturing Practices (GMP) and formulated with aluminum hydroxide as the vaccine adjuvant. The adjuvant alone will be used as a placebo in this trial. Five groups, each consisting of twelve healthy adult volunteers, will randomly receive two doses of the vaccine or placebo with a 28-day interval, along with a booster dose six months after the initial vaccination",[66,67,26,68,69,70],"Rheumatic Heart Disease","Rheumatic Heart Disease in Children","Rheumatic Diseases","Vaccine Acceptance","Vaccine",[72,73,74,75,76],"Acute rheumatic fever","Rheumatic heart disease","Vaccine development program","Group A streptococcus (GAS)","Streptococcus pyogenes","NOT_YET_RECRUITING","2025-07-17",{"date":80,"type":39},"2025-07-22",{"date":82,"type":22},"2025-10-01",{"date":84,"type":22},"2028-12-01",{"name":86,"class":46},"University of Sao Paulo General Hospital",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":16,"sex":17,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":60,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100476312","phase-3-immunogenicity-and-safety-following-in-house-recombinant-hepatitis-b-vaccine-in-indonesian-population-phase-iii-100476312","NCT05482295","Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)","Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Registered Hepatitis B Vaccine in Indonesian Population (Phase III)","Inclusion Criteria:\n\n1. Healthy individual aged 10 - 50 years old, as determined by clinical judgment, including a medical history and physical exam which confirms the absence of a current or past disease state considered significant by the investigator.\n2. Subjects\u002Fparents\u002Fguardian(s) have been informed properly regarding the study and signed the informed consent form\u002F informed assent form.\n3. Subject\u002Fparents\u002Fguardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.\n\nExclusion Criteria:\n\n1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.\n2. Subjects with known history of Hepatitis B contained vaccination in the last 10 years.\n3. Evolving severe illness and\u002For chronic disease and fever (axillary temperature \\>= 37.5 C) within the 48 hours preceding enrollment.\n4. Known history of allergy to any component of the vaccines (based on anamnesis).\n5. HBsAg positive.\n6. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).\n7. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.\n8. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppressant.\n9. Pregnancy \\& Lactation (Adult).\n10. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.","10 Years","50 Years",{"count":97,"type":22},540,[99],"PHASE3","This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.",[102,26],"Vaccine Reaction",[104],"Hepatitis B vaccine, Vaccine","2025-06-03",{"date":107,"type":39},"2025-06-06",{"date":109,"type":22},"2025-09",{"date":111,"type":22},"2026-05",{"name":113,"class":114},"PT Bio Farma","INDUSTRY",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":60,"phases":126,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":47},"100590439","phase-2-effect-of-metabolic-modulation-on-a-post-acute-covid-19-vaccination-syndrome-pacvs-cohort-100590439","NCT06967428","Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort","Effectiveness of Metabolic Modulation in Treating Post-vaccination Syndrome: A Prospective Study","ViTAL-SCAN19","Inclusion Criteria:\n\n* Persistent fatigue lasting more than 6 months\n* Received at least one dose of a Covid-19 vaccine, after which they experienced fatigue symptoms (symptom onset within two weeks of vaccination)\n* Laboratory result showing persistent spike protein in blood OR presence of spike protein antibodies with SARS-CoV-2 nucleocapsid antibodies negative.\n\nExclusion Criteria:\n\n* Pregnant\n* History of Schizophrenia\n* Currently using antidepressant medication","16 Years",{"count":125,"type":22},100,[63],"The goal of this clinical trial is to evaluate whether metabolic modulation with a combined nutraceutical product can improve symptoms and metabolic health in adults diagnosed with post-acute Covid-19 vaccination syndrome (PACVS), a condition characterized by persistent fatigue and exercise intolerance attributed to Covid-19 vaccination and confirmed by laboratory testing.\n\nThe main questions it aims to answer are:\n\nDoes the combined nutraceutical intervention improve quality of life (measured by the PAC-19QoL questionnaire) in PACVS patients?\n\nDoes the intervention improve metabolic, inflammatory, and functional biomarkers (e.g., HbA1c, blood lactate, CRP, spike protein levels, heart rate variability, 6-minute walk distance)?\n\nResearchers will compare the intervention group (receiving the ViTAL SCAN nutraceutical) to a placebo group (receiving rice protein powder with vitamin C) to determine if the intervention leads to greater improvements in symptoms and biomarker profiles.\n\nParticipants will:\n\nTake the assigned supplement daily for 3 months (ViTAL SCAN or placebo)\n\nAttend clinic visits for blood and urine sampling, physical performance tests (6-minute walk test), and heart rate monitoring\n\nComplete quality of life and health behavior questionnaires\n\nUndergo measurements of metabolic and inflammatory markers (HbA1c, lactate, CRP, spike protein)\n\nRecord supplement intake\n\nThis study is currently pending IRB approval and aims to enroll 100 adults with PACVS for a randomized, placebo-controlled trial.",[26,129],"Post Acute Covid-19 Vaccination Syndrome",[129,131,132],"Metabolic Modulation","Amino Acids","2025-05-05",{"date":135,"type":39},"2025-05-13",{"date":137,"type":22},"2025-09-01",{"date":139,"type":22},"2026-01",{"name":141,"class":46},"Independent Medical Alliance",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":16,"sex":17,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":60,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100569151","phase-1-phase-iii-open-label-randomized-safety-and-immunogenicity-following-dtwp-hepatitis-b-hib-ipv-vaccine-bio-farma-in-indonesian-infants-100569151","NCT06690515","Phase I\u002FII, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants","Inclusion Criteria:\n\n1. Infant 6-11 weeks of age.\n2. Infant born after 37-42 weeks of pregnancy.\n3. Infant weighing more than 2.5 kg at birth.\n4. Father or mother, or legally acceptable representative properly informed about the study and signed the informed consent form.\n5. Parents will commit themselves to comply with the indications of the investigators and with the schedule of the trial.\n\nExclusion Criteria:\n\n1. Child concomitantly enrolled or scheduled to be enrolled in another trial.\n2. Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥37.5°C on Day 0).\n3. Known history of allergy to any component of the vaccines.\n4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.\n5. Known history of congenital or acquired immunodeficiency (including HIV infection).\n6. Child who has received in the previous 4 weeks of a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\\> 2 weeks).\n7. Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis.\n8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.\n9. Infant with a known history of diphtheria, tetanus, pertussis, Hib, hepatitis B infection.","6 Weeks","11 Weeks",{"count":151,"type":22},465,[62,63],"This trial is open label, comparative, randomized, phase I\u002FII study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.",[26,102],"2024-11-13",{"date":157,"type":39},"2024-11-15",{"date":159,"type":22},"2025-03-01",{"date":161,"type":22},"2026-09-30",{"name":113,"class":114},3]