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2 results on '"Ten Doesschate T"'

1. Safety and COVID-19 Symptoms in Individuals Recently Vaccinated with BCG: a Retrospective Cohort Study.

Author

Moorlag SJCFM, van Deuren RC, van Werkhoven CH, Jaeger M, Debisarun P, Taks E, Mourits VP, Koeken VACM, de Bree LCJ, Ten Doesschate T, Cleophas MC, Smeekens S, Oosting M, van de Veerdonk FL, Joosten LAB, Ten Oever J, van der Meer JWM, Curtis N, Aaby P, Stabell-Benn C, Giamarellos-Bourboulis EJ, Bonten M, van Crevel R, and Netea MG

Subjects
Adult, Aged, BCG Vaccine immunology, COVID-19 immunology, Female, Humans, Immunologic Memory, Incidence, Male, Middle Aged, Netherlands epidemiology, Retrospective Studies, SARS-CoV-2, Severity of Illness Index, Young Adult, BCG Vaccine administration & dosage, COVID-19 epidemiology, Vaccination statistics & numerical data
Abstract

Bacille Calmette-Guérin (BCG) induces long-term boosting of innate immunity, termed trained immunity, and decreases susceptibility to respiratory tract infections. BCG vaccination trials for reducing SARS-CoV-2 infection are underway, but concerns have been raised regarding the potential harm of strong innate immune responses. To investigate the safety of BCG vaccination, we retrospectively assessed coronavirus disease 2019 (COVID-19) and related symptoms in three cohorts of healthy volunteers who either received BCG in the last 5 years or did not. BCG vaccination is not associated with increased incidence of symptoms during the COVID-19 outbreak in the Netherlands. Our data suggest that BCG vaccination might be associated with a decrease in the incidence of sickness during the COVID-19 pandemic (adjusted odds ratio [AOR] 0.58, p < 0.05), and lower incidence of extreme fatigue. In conclusion, recent BCG vaccination is safe, and large randomized trials are needed to reveal if BCG reduces the incidence and/or severity of SARS-CoV-2 infection., Competing Interests: M.G.N. and L.A.B.J. are scientific founders of TTxD., (© 2020 The Author(s).)

Published
2020
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2. Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials.

Author

Ten Doesschate T, Moorlag SJCFM, van der Vaart TW, Taks E, Debisarun P, Ten Oever J, Bleeker-Rovers CP, Verhagen PB, Lalmohamed A, Ter Heine R, van Crevel R, van de Wijgert J, Janssen AB, Bonten MJ, van Werkhoven CH, and Netea MG

Subjects
Adult, Aged, Aged, 80 and over, COVID-19, Female, Hospitalization, Humans, Male, Middle Aged, Multicenter Studies as Topic, SARS-CoV-2, Absenteeism, BCG Vaccine immunology, Betacoronavirus, Coronavirus Infections prevention & control, Health Personnel, Pandemics prevention & control, Pneumonia, Viral prevention & control, Randomized Controlled Trials as Topic, Vaccination
Abstract

Objectives: The objectives of these two separate trials are: (1) to reduce health care workers (HCWs) absenteeism; and (2) to reduce hospital admission among the elderly during the COVID-19 pandemic through BCG vaccination., Trial Design: Two separate multi-centre placebo-controlled parallel group randomized trials PARTICIPANTS: (1) Health care personnel working in the hospital or ambulance service where they will take care of patients with the COVID-19 infection and (2) elderly ≥60 years. The HCW trial is being undertaken in 9 hospitals. The elderly trial is being undertaken in locations in the community in Nijmegen, Utrecht, and Veghel, in the Netherlands, using senior citizen organisations to facilitate recruitment., Intervention and Comparator: For both trials the intervention group will be randomized to vaccination with 0.1 ml of the licensed BCG vaccine (Danish strain 1331, SSI, Denmark, equivalent to 0.075 mg attenuated M. bovis). The placebo group consists of 0.1 ml 0.9% NaCl, which is the same amount, and has the same colour and appearance as the suspended BCG vaccine., Main Outcomes: (1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19., Randomisation: Participants will be randomized to BCG vaccine or placebo (1;1) centrally using a computer- based system, stratified by study centre., Blinding (masking): Subjects, investigators, physicians and outcome assessors are blinded for the intervention. Only the pharmacist assistant that prepares- and research personnel that administers- study medicines are unblinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): (1) The sample size for the first trial is N=1500 HCWs randomised 1:1 to either BCG vaccine (n=750) and placebo (n=750) and (2) The sample size for the second trial is N=1600 elderly persons randomised to BCG vaccine (n=800) and the placebo group (n=800)., Trial Status: HCW: version 4.0, 24-04-2020. Recruitment began 25-03-2020 and was completed on the 23-04-2020. Elderly: version 3.0, 04-04-2020. Recruitment began 16-04- 2020 and is ongoing., Trial Registration: The HCWs trial was registered 31-03-2020 at clinicaltrials.gov (identifier: NCT04328441) and registered 20-03-2020 at the Dutch Trial Registry (trialregister.nl, identifier Trial NL8477). The elderly trial was registered 22-04-2020 at the Dutch trial registry with number NL8547., Full Protocol: The full protocols will be attached as additional files, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Published
2020
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