Clinical Trial to Assess Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes

Exclusion Criteria

• •Diagnosis of concomitant infections or diseases that might affect immunity, including active HIV infection, hepatitis B, hepatitis C, diabetes mellitus, neoplasias, and autoimmune diseases;
• •Previous or current diagnosis or family antecedent of rheumatic fever, chorea, obsessive-compulsive disorder or glomerulonephritis;
• •Previous or current diagnosis of cardiac disease;
• •Severe asma or Chronic obstructive pulmonary disease (COPD);
• •Abnormal neurological clinical assessment, particularly chorea;
• •Use of treatments that might affect the immunity in the last four weeks, including immunomodulators, corticosteroids (only systemic use equal or longer than two weeks), or antineoplastic agents;
• •Use of treatments that might affect heart valves in the latest four weeks, including fenfluramine e dexfenfluramine;
• •Kidney failure determined by creatinine clearance lower than 45 ml/min/1,73m²;
• •History of intolerance or allergy to any component of investigational products, including antigen or adjuvant;
• •Presence of abnormalities in heart valves or heart anatomy defined by echocardiogram;
• •Electrocardiogram disturbances;
• •Presence of cross-reactive antibodies against human tissues (heart, kidney, cartilage, brain) in screening tests;
• •Evidence or suspicion of recent infection due to S. pyogenes assessed by clinical symptoms and negative rapid test for Streptococcus;
• •Pregnancy, breastfeeding mother or intention to became pregnant during the study period;
• •Any other condition that might affect the study process according to the investigators.