Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers

Exclusion criteria

• ✕. Cardiovascular diseases, e.g., myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias, myocarditis, or pericarditis.
• ✕. Hypertension
• ✕. Diabetes mellitus type 1 or type 2 cases requiring medication.
• ✕. Thyroidectomy, or thyroid disease requiring medication during the last 12 months.
• ✕. Malignancy within 5 years of Visit 0, excluding localized basal or squamous cell cancer.
• ✕. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), or (in Part B only) are on a medication determined by the investigator to increase the risk of bleeding.
• ✕. Seizure disorder: History of seizure(s) within past 3 years. Also exclude if participant has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
• ✕. An abnormal screening or Visit 1 ECG (i.e., showing the corrected QT interval by Fridericia (QTcF) \>450 ms; significant ST-T wave changes suggestive of myocardial ischemia or of an acute or indeterminate-age myocardial infarction; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions; complete right or left bundle branch block \[QRS \>120 ms\]; second- or third-degree atrioventricular block); or other clinically significant abnormalities on the ECG at the investigator's discretion.