Evidence map›Paper›PMID 35582122›Full record

ArticleEClinicalMedicine2022

Safety and efficacy of BCG re-vaccination in relation to COVID-19 morbidity in healthcare workers: A double-blind, randomised, controlled, phase 3 trial.

Caryn M Upton, Rob C van Wijk, Laurynas Mockeliunas, Ulrika S H Simonsson, Kirsten McHarry, Gerben van den Hoogen, Chantal Muller, Arné von Delft, Helene-Mari van der Westhuizen, Reinout van Crevel and 5 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in EClinicalMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04379336 (Reducing Morbidity and Mortality in Health Care Workers Exposed to SARS-CoV-2 by Enhancing Non-specific Immune Responses Through Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial), which is not on this map. Cited by 55 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 2 pooled it
7.1field-weighted citation impact, top 2% 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.

NCT04379336 phase3completednot on this map

Reducing Morbidity and Mortality in Health Care Workers Exposed to SARS-CoV-2 by Enhancing Non-specific Immune Responses Through Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial

TypeinterventionalSponsorTASK Applied ScienceRan2020 to 2022Enrolled1,000ConditionsCOVID-19, Sars-CoV2ArmsBacille Calmette-Guérin (BCG), Placebo Comparator
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 2 syntheses or guidelines pooled it, 84 citations in OpenAlex.

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  6. 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

15 authors at 6 institutions in 4 countries.

Caryn M UptonTASK HQ, Cape Town 7500, South Africa.
Rob C van WijkDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Laurynas MockeliunasDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Ulrika S H SimonssonDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Kirsten McHarryTASK Eden, George, South Africa.
Gerben van den HoogenTASK HQ, Cape Town 7500, South Africa.
Chantal MullerDepartment of Medicine, University of Cape Town Lung Institute and Division of Allergy and Clinical Immunology, University of Cape Town, Cape Town, South Africa.
Arné von DelftCentre for Infectious Diseases Research in Africa, Cape Town, South Africa.
Helene-Mari van der WesthuizenTB Proof, Cape Town, South Africa.
Reinout van CrevelRadboud University Medical Center, Nijmegen, the Netherlands.
Gerhard WalzlDST/NRF Centre of Excellence for Biomedical TB Research, and SAMRC Centre for TB Research, Division of Molecular Biology and Human Genetics, Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, Francie Van Zijl Drive, Parow 7505, South Africa.
Pedro M BaptistaSpain and ARAID Foundation, Institute of Health Research Aragon (IIS Aragon), Zaragoza, Spain.
Jonathan PeterDepartment of Medicine, University of Cape Town Lung Institute and Division of Allergy and Clinical Immunology, University of Cape Town, Cape Town, South Africa.
Andreas H DiaconTASK HQ, Cape Town 7500, South Africa.
BCG CORONA Consortium
Task Applied Science · ZAUniversity of Cape Town · ZAUppsala University · SEFundacion Agencia Aragonesa para la Investigacion y el Desarrollo · ESRadboud University Nijmegen · NLSouth African Medical Research Council · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: BCG vaccination prevents severe childhood tuberculosis (TB) and was introduced in South Africa in the 1950s. It is hypothesised that BCG trains the innate immune system by inducing epigenetic and functional reprogramming, thus providing non-specific protection from respiratory tract infections. We evaluated BCG for reduction of morbidity and mortality due to COVID-19 in healthcare workers in South Africa. Methods: This randomised, double-blind, placebo-controlled trial recruited healthcare workers at three facilities in the Western Cape, South Africa, unless unwell, pregnant, breastfeeding, immunocompromised, hypersensitivity to BCG, or undergoing experimental COVID-19 treatment. Participants received BCG or saline intradermally (1:1) and were contacted once every 4 weeks for 1 year. COVID-19 testing was guided by symptoms. Hospitalisation, COVID-19, and respiratory tract infections were assessed with Cox proportional hazard modelling and time-to-event analyses, and event severity with post hoc Markovian analysis. This study is registered with ClinicalTrials.gov, NCT04379336. Findings: Between May 4 and Oct 23, 2020, we enrolled 1000 healthcare workers with a median age of 39 years (IQR 30-49), 70·4% were female, 16·5% nurses, 14·4% medical doctors, 48·5% had latent TB, and 15·3% had evidence of prior SARS-CoV-2 exposure. Hospitalisation due to COVID-19 occurred in 15 participants (1·5%); ten (66·7%) in the BCG group and five (33·3%) in the placebo group, hazard ratio (HR) 2·0 (95% CI 0·69-5·9, Interpretation: BCG did not protect healthcare workers from SARS-CoV-2 infection or related severe COVID-19 disease and hospitalisation. Funding: Funding provided by EDCTP, grant number RIA2020EF-2968. Additional funding provided by private donors including: Mediclinic, Calavera Capital (Pty) Ltd, Thys Du Toit, Louis Stassen, The Ryan Foundation, and Dream World Investments 401 (Pty) Ltd. The computations were enabled by resources in project SNIC 2020-5-524 provided by the Swedish National Infrastructure for Computing (SNIC) at UPPMAX, partially funded by the Swedish Research Council through grant agreement No. 2018-05,973.

Indexed as

BCGCOVID-19PandemicRespiratory tract infectionTrained immunityTuberculosisVaccine

Identifiers

PMID35582122
PMCPMC9098089
OpenAlexW4280547088

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.