Allergy to the BCG vaccine or any BCG vaccine contraindication Fever (>38 C) within the past 24 hours or generalised skin diseases such as infection, eczema, dermatitis or psoriasis at or near the site of vaccination. Pregnancy Cases with active or latent Mycobacterium tuberculosis Known HIV infection Individuals with any serious underlying illness (such as malignancy) except those with cardiovascular disease, hypertension, diabetes, and/or chronic respiratory disease if they are not immunocompromised Live vaccine administered for 4 weeks prior to randomization Suspected to active viral or bacterial infections Individuals with a SARS-CoV-2 positive test result Severely immunocompromised subject or who has taken immunosuppressive therapy in the last years

Allergy to the BCG vaccine or any BCG vaccine contraindication Fever (>38 C) within the past 24 hours or generalised skin diseases such as infection, eczema, dermatitis or psoriasis at or near the site of vaccination. Pregnancy Cases with active or latent Mycobacterium tuberculosis Known HIV infection Individuals with any serious underlying illness (such as malignancy) except those with cardiovascular disease, hypertension, diabetes, and/or chronic respiratory disease if they are not immunocompromised Live vaccine administered for 4 weeks prior to randomization Suspected to active viral or bacterial infections Individuals with a SARS-CoV-2 positive test result Severely immunocompromised subject or who has taken immunosuppressive therapy in the last years