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Safety and efficacy...
Safety and efficacy of BCG re-vaccination in relation to COVID-19 morbidity in healthcare workers : A double- blind, randomised, controlled, phase 3 trial
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- Upton, Caryn M. (författare)
- TASK HQ, ZA-7500 Cape Town, South Africa.
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- Van Wijk, Rob C, 1991- (författare)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap
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- Mockeliunas, Laurynas (författare)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap
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- Simonsson, Ulrika S. H., Professor (författare)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap
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- McHarry, Kirsten (författare)
- TASK Eden, George, South Africa.
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- van den Hoogen, Gerben (författare)
- TASK HQ, ZA-7500 Cape Town, South Africa.
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- Muller, Chantal (författare)
- Univ Cape Town, Dept Med, Lung Inst, Cape Town, South Africa.;Univ Cape Town, Div Allergy & Clin Immunol, Cape Town, South Africa.
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- von Delft, Arne (författare)
- Ctr Infect Dis Res Africa, Cape Town, South Africa.
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- van der Westhuizen, Helene-Mari (författare)
- TB Proof, Cape Town, South Africa.
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- van Crevel, Reinout (författare)
- Radboud Univ Nijmegen Med Ctr, Nijmegen, Netherlands.
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- Walzl, Gerhard (författare)
- Stellenbosch Univ, Div Mol Biol & Human Genet, DST NRF Ctr Excellence Biomed TB Res, Dept Biomed Sci,Fac Med & Hlth Sci, Francie Van Zijl Dr, ZA-7505 Parow, South Africa.;Stellenbosch Univ, Div Mol Biol & Human Genet, SAMRC Ctr TB Res, Dept Biomed Sci,Fac Med & Hlth Sci, Francie Van Zijl Dr, ZA-7505 Parow, South Africa.
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- Baptista, Pedro M. (författare)
- Inst Hlth Res Aragon IIS Aragon, Spain & ARAID Fdn, Zaragoza, Spain.
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- Peter, Jonathan (författare)
- Univ Cape Town, Dept Med, Lung Inst, Cape Town, South Africa.;Univ Cape Town, Div Allergy & Clin Immunol, Cape Town, South Africa.
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- Diacon, Andreas H. (författare)
- TASK HQ, ZA-7500 Cape Town, South Africa.
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TASK HQ, ZA-7500 Cape Town, South Africa Institutionen för farmaceutisk biovetenskap (creator_code:org_t)
- Elsevier, 2022
- 2022
- Engelska.
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Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 48
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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, p= 0.20), indicating no statistically significant protection. Similarly, BCG had no statistically significant effect on COVID-19 (p= 0.63, HR = 1.08, 95% CI 0.82-1.42). Two participants (0.2%) died from COVID-19 and two (0.2%) from other reasons, all in the placebo group. Interpretation BCG did not protect healthcare workers from SARS-CoV-2 infection or related severe COVID-19 disease and hospitalisation.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
Nyckelord
- COVID-19
- BCG
- Respiratory tract infection
- Vaccine
- Tuberculosis
- Trained immunity
- Pandemic
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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- Av författaren/redakt...
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Upton, Caryn M.
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Van Wijk, Rob C, ...
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Mockeliunas, Lau ...
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Simonsson, Ulrik ...
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McHarry, Kirsten
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van den Hoogen, ...
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Muller, Chantal
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von Delft, Arne
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van der Westhuiz ...
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van Crevel, Rein ...
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Walzl, Gerhard
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Baptista, Pedro ...
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Peter, Jonathan
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Diacon, Andreas ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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Uppsala universitet