BCG vaccine for seniors to prevent infections during the COVID-19 pandemic.

Phase 1

• Conditions: 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: 23.0Level: LLTClassification code 10084382Term: Coronavirus disease 2019System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-003904-15-DK
• Lead Sponsor: niversity of Southern Denmark

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-11
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1900

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified