[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598966":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":67,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":97,"overallStatus":103,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low dose Synthetic Vaccine Against Streptococcus Pyogenes- First arm","EXPERIMENTAL","25 mcg \u002F 50 mcg \u002F 100 mcg \u002F 200mcg of the experimental vaccine will be administered.",[13],"Other: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Aluminum hydroxide (a vaccine adjuvant) - fifth arm","PLACEBO_COMPARATOR","Aluminum hydroxide (a vaccine adjuvant) will be administered as a placebo",[19,13],"Biological: StrepIncor",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","StrepIncor","This arm will include 25\u002F50\u002F100\u002F200 µg compared to placebo",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","A placebo (aluminum adjuvant) will be administered and compared to the other study arms",[15,9],[32],{"name":33,"affiliation":34,"role":35},"Jorge E Kalil Filho, Full Professor, MD, PhD","Heart Institute - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"RONEY O SAMPAIO, MD, PhD","CONTACT","+ 55-11- 2661-5056","roney.sampaio@hc.fm.usp.br",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"SELMA PALACIOS, PhD","+55-11-2661-5901","selmapalacios@yahoo.com.br",[47],{"facility":48,"status":26,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Heart Institute - Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de São Paulo","São Paulo","05403000","Brazil","BR",{"type":54,"coordinates":55},"Point",[56,57],-46.63611,-23.5475,{"lat":57,"lon":56},[60,62,64],{"name":38,"role":39,"phone":61,"phoneExt":26,"email":41},"+55-11-2661-5056",{"name":38,"role":63,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":65,"role":66,"phone":26,"phoneExt":26,"email":26},"LUIZA GUILHERME, PhD","SUB_INVESTIGATOR",{"type":63,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Roney Orismar Sampaio","MD, PhD","100598966","phase-1-clinical-trial-phase-iiia-to-evaluate-the-safety-and-immunogenicity-of-streptincor-100598966",false,"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.",true,"ALL","18 Years","45 Years",{"count":83,"type":84},60,"ESTIMATED","INTERVENTIONAL",[87,88],"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",[91,92,93,94,95,96],"Rheumatic Heart Disease","Rheumatic Heart Disease in Children","Vaccine Adverse Reaction","Rheumatic Diseases","Vaccine Acceptance","Vaccine",[98,99,100,101,102],"Acute rheumatic fever","Rheumatic heart disease","Vaccine development program","Group A streptococcus (GAS)","Streptococcus pyogenes","NOT_YET_RECRUITING","2025-07-17",{"date":106,"type":107},"2025-07-22","ACTUAL",{"date":109,"type":84},"2025-10-01",{"date":111,"type":84},"2028-12-01",{"name":5,"class":6},1]