Evidence map›Paper›PMID 35489606›Full record

Trial reportClinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases2022

Bacillus Calmette-Guérin vaccine to reduce healthcare worker absenteeism in COVID-19 pandemic, a randomized controlled trial.

Thijs Ten Doesschate, Thomas W van der Vaart, Priya A Debisarun, Esther Taks, Simone J C F M Moorlag, Nienke Paternotte, Wim G Boersma, Vincent P Kuiper, Anna H E Roukens, Bart J A Rijnders and 11 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03987919. Cited by 43 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 2 pooled it
5.7field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03987919 phase3completed

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Ran2019Enrolled1,879Registered outcomes10Posted comparisons27ConditionsType 2 DiabetesArmssemaglutide, Tirzepatide
Open the trial in the graph
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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  3. The effect of BCG vaccination on infection and antibody levels against SARS-CoV-2-The results of ProBCG: a multicenter randomized clinical trial in Brazil.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 11 institutions in 2 countries.

Thijs Ten DoesschateJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, the Netherlands. Electronic address: T.tenDoesschate@umcutrecht.nl.
Thomas W van der VaartJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, the Netherlands; Department of Infectious Diseases, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Priya A DebisarunDepartment of Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.
Esther TaksDepartment of Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.
Simone J C F M MoorlagDepartment of Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.
Nienke PaternotteJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, the Netherlands; Department of Pulmonology, North-West-Hospital, Alkmaar, the Netherlands.
Wim G BoersmaDepartment of Pulmonology, North-West-Hospital, Alkmaar, the Netherlands.
Vincent P KuiperDepartment of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.
Anna H E RoukensDepartment of Infectious Diseases, Leiden University Medical Center, Leiden, the Netherlands.
Bart J A RijndersDepartment of Internal Medicine, Section of Infectious Diseases and Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, the Netherlands.
Andreas VossDepartment of Medical Microbiology and Infectious Diseases, Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands.
Karin M VeermanDepartment of Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands; Department of Internal Medicine, Sint Maartenskliniek, Nijmegen, the Netherlands.
Angele P M KerckhoffsDepartment of Internal Medicine, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.
Jaap Ten OeverDepartment of Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.
Reinout van CrevelDepartment of Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.
Cees van NieuwkoopHaga Teaching Hospital, Department of Internal Medicine, The Hague, the Netherlands.
Arief LalmohamedDepartment of Clinical Pharmacy, University Medical Center Utrecht, University of Utrecht, Utrecht, the Netherlands; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.
Janneke H H M van de WijgertJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, the Netherlands.
Mihai G NeteaDepartment of Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands; Department for Genomics & Immunoregulation, Life and Medical Sciences Institute (LIMES), University of Bonn, Germany.
Marc J M BontenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, the Netherlands.
Cornelis H van WerkhovenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, the Netherlands. Electronic address: C.H.vanWerkhoven@umcutrecht.nl.
University Medical Center Utrecht · NLRadboud University Nijmegen · NLLeiden University Medical Center · NLCanisius-Wilhelmina Ziekenhuis · NLErasmus MC · NLHaga Hospital · NLJeroen Bosch Ziekenhuis · NLMedisch Centrum Alkmaar · NLRadboud University Medical Center · NLSint Maartenskliniek · NLUniversity of Bonn · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe COVID-19 pandemic increases healthcare worker (HCW) absenteeism. The bacillus Calmette-Guérin (BCG) vaccine may provide non-specific protection against respiratory infections through enhancement of trained immunity. We investigated the impact of BCG vaccination on HCW absenteeism during the COVID-19 pandemic.

methodsHCWs exposed to COVID-19 patients in nine Dutch hospitals were randomized to BCG vaccine or placebo in a 1:1 ratio, and followed for one year using a mobile phone application. The primary endpoint was the self-reported number of days of unplanned absenteeism for any reason. Secondary endpoints included documented COVID-19, acute respiratory symptoms or fever. This was an investigator-funded study, registered at ClinicalTrials.gov (NCT03987919).

resultsIn March/April 2020, 1511 HCWs were enrolled. The median duration of follow-up was 357 person-days (interquartile range [IQR], 351 to 361). Unplanned absenteeism for any reason was observed in 2.8% of planned working days in the BCG group and 2.7% in the placebo group (adjusted relative risk 0.94; 95% credible interval, 0.78-1.15). Cumulative incidences of documented COVID-19 were 14.2% in the BCG and 15.2% in the placebo group (adjusted hazard ratio (aHR) 0.94; 95% confidence interval (CI), 0.72-1.24). First episodes of self-reported acute respiratory symptoms or fever occurred in 490 (66.2%) and 443 (60.2%) participants, respectively (aHR: 1.13; 95% CI, 0.99-1.28). Thirty-one serious adverse events were reported (13 after BCG, 18 after placebo), none considered related to study medication.

conclusionsDuring the COVID-19 pandemic, BCG-vaccination of HCW exposed to COVID-19 patients did not reduce unplanned absenteeism nor documented COVID-19.

Indexed as

COVID-19Mycobacterium bovisAbsenteeismBCG VaccineHealth PersonnelHumansPandemicsSARS-CoV-2BCG VaccineBCGCOVID-19Health care workersRandomized controlled trialTrained immunity

Identifiers

PMID35489606
PMCPMC9046133
OpenAlexW4224979137

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.