Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT03998592
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers, both sex, aging 18 to 45 years;
* Availability for all procedures during the study period;
* Provide free informed consent to join the study
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03998592
Study Brief:
Protocol Section:
NCT03998592