Tuberculosis vaccination to Reduce the impact of Coronavirus infection in healthcare workers

Phase 1

• Conditions: SARS-CoV-2 infection; MedDRA version: 20.0Level: HLTClassification code 10047490Term: Virus identification and serologySystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002503-19-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-05
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

•Over 18 years of age
•Healthcare worker
•Provide a signed and dated informed consent form
•Pre-randomisation blood collected

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 10000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1Has any BCG vaccine contraindication
oFever or generalised skin infection (where feasible, randomisation can be delayed until cleared)
oWeakened resistance toward infections due to a disease in/of the immune system
oPeople with any serious underlying illness (such as malignancy)
oKnown or suspected HIV infection,11 even if they are asymptomatic or have normal immune function.
oPeople with active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination
oPregnant
oAnother live vaccine administered in the month prior to randomisation
oRequire another live vaccine to be administered within the month following BCG randomisation
oKnown anaphylactic reaction to any of the ingredient present in the BCG vaccine
oPrevious active TB disease
oCurrently receiving long term (more than 1 month) treatment with isoniazid, rifampicin or quinolone as these antibiotics have activity against Mycobacterium bovis
2Previous adverse reaction to BCG vaccine (significant local reaction (abscess) or suppurative lymphadenitis)
3BCG vaccine given within the last year
4Have previously had a SARS-CoV-2 positive test result (positive PCR on a respiratory sample or a positive SARS-CoV-2 diagnostic antigen test approved by the local jurisdiction’s public health policy
5Already part of this trial, recruited at a different hospital.
6Participation in another COVID-19 prevention trial
7Have previously received a COVID-19 specific vaccine

Study & Design

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