Healthy volunteers, senior citizens of 65 years or older. Immune system activation after BCG vaccination. Acute infections, COVID-19 and self-reported respiratory illness will be monitored. MedDRA version: 23.0 Level: LLT Classification code 10084382 Term: Coronavirus disease 2019 System Organ Class: 100000004862
Conditions
Sponsors
University of Southern Denmark
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: =65 years old. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1900
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Known allergy to (components of) the BCG vaccine or serious adverse events in relation to prior BCG administration • Previous Mycobacterium tuberculosis (M. tuberculosis) infection or known active or latent infection with M. tuberculosis or other mycobacterial species • Previous confirmed COVID-19 infection • Fever (>38 C) within the past 24 hours or suspicion of active viral or bacterial infection • Vaccination with other live attenuated vaccine within the last 4 weeks • Subjects who do not have access to e-Boks • Severely immunocompromised subjects. This exclusion category comprises: • Subjects with known infection with human immunodeficiency virus (HIV) • Subjects with solid organ transplantation or bone marrow transplantation • Subjects under chemotherapy • Subjects with primary immunodeficiency • Treatment with any anti-cytokine therapy within the last year • Treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months • Active solid or non-solid malignancy or lymphoma within the prior two years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To reduce senior citizens’ risk of acute infection during the COVID-19 pandemic. ;Secondary Objective: Secondary objectives: To reduce senior citizens’ risk of SARS-CoV-2 infection during the COVID-19 pandemic. To reduce senior citizens’ risk of self-reported respiratory illness during the COVID-19 pandemic.;Primary end point(s): The primary outcome is acute infection identified either by a doctor, antibiotics use, hospitalization or death due to infection. ;Timepoint(s) of evaluation of this end point: End of trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes are verified SARS-CoV-2 infection and self-reported respiratory illness. Supplementary analyses will explore the effect of the intervention on severity of any SARS-CoV-2 infection.;Timepoint(s) of evaluation of this end point: End of trial. | — |
Countries
Denmark
Contacts
Public ContactDep. of Clinical Research, OPEN
University of Southern Denmark
Outcome results
None listed