BCG vaccine for healthcare workers against COVID-19

Phase 1

• Conditions: Healthy volunteers, health care workers.Immune system activation after BCG vaccination. Work absenteeism and COVID-19 will be monitored.; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001888-90-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: 2020-04-16
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Adult (=18 years); Hospital personnel working at one of the participating hospitals.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration; Known active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species; Previous M. tuberculosis infection; Previous confirmed COVID-19 infection; Fever (>38 C) within the past 24 hours; Suspicion of active viral or bacterial infection; Pregnancy; Breastfeeding; Vaccination with other live attenuated vaccine within the last 4 weeks; Severely immunocompromised subjects. This exclusion category comprises a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) subjects with solid organ transplantation; c) subjects with bone marrow transplantation; d) subjects under chemotherapy; e) subjects with primary immunodeficiency; f) treatment with any anti-cytokine therapies. g) 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; Direct involvement in the design or the execution of the BCG-DENMARK-COVID study; Employed to the hospital < 22 hours per week.

Study & Design

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