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389 results on '"van Werkhoven, Cornelis H."'

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

Author

ten Doesschate, Thijs, van der Vaart, Thomas W., Debisarun, Priya A., Taks, Esther, Moorlag, Simone J.C.F.M., Paternotte, Nienke, Boersma, Wim G., Kuiper, Vincent P., Roukens, Anna H.E., Rijnders, Bart J.A., Voss, Andreas, Veerman, Karin M., Kerckhoffs, Angele P.M., Oever, Jaap ten, van Crevel, Reinout, van Nieuwkoop, Cees, Lalmohamed, Arief, van de Wijgert, Janneke H.H.M., Netea, Mihai G., Bonten, Marc J.M., and van Werkhoven, Cornelis H.

Published
2022
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11. Narrow-spectrum antibiotics for community-acquired pneumonia in Dutch adults (CAP-PACT): a cross-sectional, stepped-wedge, cluster-randomised, non-inferiority, antimicrobial stewardship intervention trial

Author

Schweitzer, Valentijn A, van Heijl, Inger, Boersma, Wim G, Rozemeijer, Wouter, Verduin, Kees, Grootenboers, Marco J, Sankatsing, Sanjay U C, van der Bij, Akke K, de Bruijn, Winnie, Ammerlaan, Heidi S M, Overdevest, Ilse, Roorda-van der Vegt, J M Milena, Engel-Dettmers, Elske M, Ayuketah-Ekokobe, Florence E, Haeseker, Michiel B, Dorigo-Zetsma, J Wendelien, van der Linden, Paul D, Boel, C H Edwin, Oosterheert, Jan J, van Werkhoven, Cornelis H, and Bonten, Marc J M

Published
2022
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12. Diagnostic Stewardship in Community-Acquired Pneumonia With Syndromic Molecular Testing

Author

Markussen, Dagfinn L., primary, Serigstad, Sondre, additional, Ritz, Christian, additional, Knoop, Siri T., additional, Ebbesen, Marit H., additional, Faurholt-Jepsen, Daniel, additional, Heggelund, Lars, additional, van Werkhoven, Cornelis H., additional, Clark, Tristan W., additional, Bjørneklett, Rune O., additional, Kommedal, Øyvind, additional, Ulvestad, Elling, additional, and Grewal, Harleen M. S., additional

Published
2024
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16. Higher-valency pneumococcal conjugate vaccines in older adults, taking into account indirect effects from childhood vaccination: a cost-effectiveness study for the Netherlands

Author

Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Onderzoek, Child Health, de Boer, Pieter T., van Werkhoven, Cornelis H., van Hoek, Albert Jan, Knol, Mirjam J., Sanders, Elisabeth A.M., Wallinga, Jacco, de Melker, Hester E., Steens, Anneke, Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Onderzoek, Child Health, de Boer, Pieter T., van Werkhoven, Cornelis H., van Hoek, Albert Jan, Knol, Mirjam J., Sanders, Elisabeth A.M., Wallinga, Jacco, de Melker, Hester E., and Steens, Anneke

Published
2024

17. Association between work sick-leave absenteeism and SARS-CoV-2 notifications in the Netherlands during the COVID-19 epidemic

Author

Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Keet, Martijn G., Boudewijns, Bronke, Jongenotter, Femke, van Iersel, Senna, van Werkhoven, Cornelis H., van Gageldonk-Lafeber, Rianne B., Wisse, Bram W., van Asten, Liselotte, Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Keet, Martijn G., Boudewijns, Bronke, Jongenotter, Femke, van Iersel, Senna, van Werkhoven, Cornelis H., van Gageldonk-Lafeber, Rianne B., Wisse, Bram W., and van Asten, Liselotte

Published
2024

18. Informed consent for national registration of COVID-19 vaccination caused information bias of vaccine effectiveness estimates mostly in older adults: a bias correction study

Author

Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectious Diseases, van Werkhoven, Cornelis H., de Gier, Brechje, McDonald, Scott A., de Melker, Hester E., Hahné, Susan J.M., van den Hof, Susan, Knol, Mirjam J., Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectious Diseases, van Werkhoven, Cornelis H., de Gier, Brechje, McDonald, Scott A., de Melker, Hester E., Hahné, Susan J.M., van den Hof, Susan, and Knol, Mirjam J.

Published
2024

19. Diagnostic Stewardship in Community-Acquired Pneumonia with Syndromic Molecular Testing: A Randomized Clinical Trial

Author

Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectious Diseases, Markussen, Dagfinn L., Serigstad, Sondre, Ritz, Christian, Knoop, Siri T., Ebbesen, Marit H., Faurholt-Jepsen, Daniel, Heggelund, Lars, Van Werkhoven, Cornelis H., Clark, Tristan W., Bjørneklett, Rune O., Kommedal, Øyvind, Ulvestad, Elling, Grewal, Harleen M.S., Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectious Diseases, Markussen, Dagfinn L., Serigstad, Sondre, Ritz, Christian, Knoop, Siri T., Ebbesen, Marit H., Faurholt-Jepsen, Daniel, Heggelund, Lars, Van Werkhoven, Cornelis H., Clark, Tristan W., Bjørneklett, Rune O., Kommedal, Øyvind, Ulvestad, Elling, and Grewal, Harleen M.S.

Published
2024

20. Acute kidney injury in Staphylococcus aureus bacteraemia: a recurrent events analysis

Author

Infection & Immunity, JC onderzoeksprogramma Infectious Diseases, Epi Infectieziekten Team 1, Epi Infectieziekten, Epidemiology of Sepsis & Inflammation in Critically Ill Patients, Buis, David T P, van der Vaart, Thomas W, Mohan, Asna, Prins, Jan M, van der Meer, Jan T M, Bonten, Marc J M, Jakulj, Lily, van Werkhoven, Cornelis H, Sigaloff, Kim C E, Infection & Immunity, JC onderzoeksprogramma Infectious Diseases, Epi Infectieziekten Team 1, Epi Infectieziekten, Epidemiology of Sepsis & Inflammation in Critically Ill Patients, Buis, David T P, van der Vaart, Thomas W, Mohan, Asna, Prins, Jan M, van der Meer, Jan T M, Bonten, Marc J M, Jakulj, Lily, van Werkhoven, Cornelis H, and Sigaloff, Kim C E

Published
2024

21. Biomarker guided antibiotic stewardship in community acquired pneumonia: A randomized controlled trial

Author

Epi Infectieziekten, Infection & Immunity, Epidemiology of Sepsis & Inflammation in Critically Ill Patients, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten Team 1, Duijkers, Ruud, Prins, Hendrik J., Kross, Martijn, Snijders, Dominic, van den Berg, Jan W.K., Werkman, Gwendolyn M., van der Veen, Nynke, Schoorl, Marianne, Bonten, Marc J.M., van Werkhoven, Cornelis H., Boersma, Wim G., Epi Infectieziekten, Infection & Immunity, Epidemiology of Sepsis & Inflammation in Critically Ill Patients, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten Team 1, Duijkers, Ruud, Prins, Hendrik J., Kross, Martijn, Snijders, Dominic, van den Berg, Jan W.K., Werkman, Gwendolyn M., van der Veen, Nynke, Schoorl, Marianne, Bonten, Marc J.M., van Werkhoven, Cornelis H., and Boersma, Wim G.

Published
2024

22. Which trial do we need? A sequential multiple assignment randomized trial to determine the optimal Clostridioides difficile treatment sequence

Author

Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, van Prehn, Joffrey, van Werkhoven, Cornelis H., Skinner, Andrew M., Guery, Benoit, Dubberke, Erik R., Kuijper, Ed J., Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, van Prehn, Joffrey, van Werkhoven, Cornelis H., Skinner, Andrew M., Guery, Benoit, Dubberke, Erik R., and Kuijper, Ed J.

Published
2024

23. Biomarker guided antibiotic stewardship in community acquired pneumonia: A randomized controlled trial.

Author

Duijkers, Ruud, Prins, Hendrik J., Kross, Martijn, Snijders, Dominic, van den Berg, Jan W. K., Werkman, Gwendolyn M., van der Veen, Nynke, Schoorl, Marianne, Bonten, Marc J. M., van Werkhoven, Cornelis H., and Boersma, Wim G.

Subjects
COMMUNITY-acquired pneumonia, C-reactive protein, RANDOMIZED controlled trials, ANTIMICROBIAL stewardship, TEACHING hospitals
Abstract

Background: In community-acquired pneumonia (CAP), the role of biomarkers to shorten duration of antibiotic treatment has not been firmly established. We assessed the effectiveness of active feedback of treatment algorithms based on procalcitonin (PCT) and C-reactive protein (CRP), compared to standard care, on the duration of antibiotic treatment in patients hospitalized with community-acquired pneumonia (CAP) in non-ICU wards. Methods and findings: We performed a randomised, open label, parallel group, multi-centre trial in 3 Dutch teaching hospitals. Treatment was guided by a PCT algorithm, CRP algorithm or standard care. Participants were recruited by a member of the study team and randomised at day 2–3 of admission in a 1:1:1 ratio. Treatment was discontinued upon predefined thresholds of biomarkers that were assessed on admission, day 4 and days 5–7 if indicated. The primary outcome was total days on antibiotic treatment until day 30. In total 468 participants were included in this study. The median days on antibiotics (IQR) was 7 (IQR 7–10) in the control group, 4 (IQR 3–7) in the CRP group (rate ratio (RR) of 0.70, 95% CI 0.61–0.82 compared to standard care; p <0.001), and 5.5 (IQR 3–9) in the PCT group (RR of 0.78, 95% CI 0.68–0.89 compared to standard care; p <0.001). New antibiotics within the first 30 days were prescribed to 24, 23 and 35 patients in standard care, CRP and PCT groups, respectively. The hazard ratio for a new prescription in patients in the PCT group compared to standard care 1.63 (CI 0.97–2.75; p = 0.06). No difference in time to clinical stability or length of stay was found. Conclusions: A strategy of feedback of CRP-guided and PCT-guided treatment algorithms reduced the number of days on antibiotic in the first 30 days after hospital admission in non-ICU wards for CAP. The study was not powered to determine safety of shortening duration of antibiotic treatment. (NCT01964495). [ABSTRACT FROM AUTHOR]

Published
2024
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24. Safety and COVID-19 Symptoms in Individuals Recently Vaccinated with BCG: a Retrospective Cohort Study

Author

Moorlag, Simone J.C.F.M., van Deuren, Rosanne C., van Werkhoven, Cornelis H., Jaeger, Martin, Debisarun, Priya, Taks, Esther, Mourits, Vera P., Koeken, Valerie A.C.M., de Bree, L. Charlotte J., ten Doesschate, Thijs, Cleophas, Maartje C., Smeekens, Sanne, Oosting, Marije, van de Veerdonk, Frank L., Joosten, Leo A.B., ten Oever, Jaap, van der Meer, Jos W.M., Curtis, Nigel, Aaby, Peter, Stabell-Benn, Christine, Giamarellos-Bourboulis, Evangelos J., Bonten, Marc, van Crevel, Reinout, and Netea, Mihai G.

Published
2020
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32. Corrigendum: The impact of circadian rhythm on Bacillus Calmette-Guérin vaccination effects on SARS-CoV-2 infections

Author

Föhse, Konstantin, primary, Taks, Esther J. M., additional, Moorlag, Simone J. C. F. M., additional, Bonten, Marc J. M., additional, van Crevel, Reinout, additional, ten Oever, Jaap, additional, van Werkhoven, Cornelis H., additional, Netea, Mihai G., additional, van de Maat, Josephine S., additional, and Hoogerwerf, Jacobien J., additional

Published
2023
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33. BCG Vaccination of Health Care Workers Does Not Reduce SARS-CoV-2 Infections nor Infection Severity or Duration: a Randomized Placebo-Controlled Trial

Author

Claus, Juana, primary, ten Doesschate, Thijs, additional, Gumbs, Cheyenne, additional, van Werkhoven, Cornelis H., additional, van der Vaart, Thomas W., additional, Janssen, Axel B., additional, Smits, Gaby, additional, van Binnendijk, Rob, additional, van der Klis, Fiona, additional, van Baarle, Debbie, additional, Paganelli, Fernanda L., additional, Leavis, Helen, additional, Verhagen, Lilly M., additional, Joosten, Simone A., additional, Bonten, Marc J. M., additional, Netea, Mihai G., additional, van de Wijgert, Janneke H. H. M., additional, Boersma, Wim G., additional, Bulut, Özlem, additional, van Crevel, Reinout, additional, Debisarun, Priya A., additional, Hoogerwerf, Jacobien, additional, de Jonge, Marien, additional, Kerckhoffs, Angele P. M., additional, Knol, Edward, additional, Koopman, Jan Pieter R., additional, Kuiper, Vincent P., additional, Lalmohamed, Arief, additional, Moorlag, Simone J. C. F. M., additional, Nierkens, Stefan, additional, van Nieuwkoop, Cees, additional, 10 Oever, Jaap, additional, Ottenhoff, Tom H. M., additional, Paternotte, Nienke, additional, Rijnders, Bart J. A., additional, Roukens, Anna H. E., additional, Taks, Esther, additional, Top, Janetta, additional, Veerman, Karin M., additional, Voss, Andreas, additional, and Willems, Rob, additional

Published
2023
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34. Positive Impact of [18F]FDG-PET/CT on Mortality in Patients With Staphylococcus aureus Bacteremia Explained by Immortal Time Bias

Author

van der Vaart, Thomas W, primary, Prins, Jan M, additional, van Werkhoven, Cornelis H, additional, ten Doesschate, Thijs, additional, Soetekouw, Robin, additional, van Twillert, Gitte, additional, Veenstra, Jan, additional, Herpers, Bjorn L, additional, Rozemeijer, Wouter, additional, Jansen, Rogier R, additional, Bonten, Marc J M, additional, and van der Meer, Jan T M, additional

Published
2023
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35. Implementation of an evidence-based management algorithm for patients with chronic pancreatitis (COMBO trial):study protocol for a stepped-wedge cluster-randomized controlled trial

Author

de Rijk, Florence E.M., van Veldhuisen, Charlotte L., Besselink, Marc G., van Hooft, Jeanin E., van Santvoort, Hjalmar C., van Geenen, Erwin J.M., van Werkhoven, Cornelis H., de Jonge, Pieter Jan F., Bruno, Marco J., Verdonk, Robert C., de Rijk, Florence E.M., van Veldhuisen, Charlotte L., Besselink, Marc G., van Hooft, Jeanin E., van Santvoort, Hjalmar C., van Geenen, Erwin J.M., van Werkhoven, Cornelis H., de Jonge, Pieter Jan F., Bruno, Marco J., and Verdonk, Robert C.

Abstract

Background: Chronic pancreatitis (CP) is an inflammatory disease that may be complicated by abdominal pain, pancreatic dysfunction, nutritional deficiencies, and diminished bone density. Importantly, it is also associated with a substantially impaired quality of life and reduced life expectancy. This may partly be explained by suboptimal treatment, in particular the long-term management of this chronic condition, despite several national and international guidelines. Standardization of care through a structured implementation of guideline recommendations may improve the level of care and lower the complication rate of these patients. Therefore, the aim of the present study is to evaluate to what extent patient education and standardization of care, through the implementation of an evidence-based integrated management algorithm, improve quality of life and reduce pain severity in patients with CP. Methods: The COMBO trial is a nationwide stepped-wedge cluster-randomized controlled trial. In a stepwise manner, 26 centers, clustered in 6 health regions, cross-over from current practice to care according to an evidence-based integrated management algorithm. During the current practice phase, study participants are recruited and followed longitudinally through questionnaires. Individual patients contribute data to both study periods. Co-primary study endpoints consist of quality of life (assessed by the PANQOLI score) and level of pain (assessed by the Izbicki questionnaire). Secondary outcomes include process measure outcomes, clinical outcomes (e.g., pancreatic function, nutritional status, bone health, interventions, medication use), utilization of healthcare resources, (in) direct costs, and the level of social participation. Standard follow-up is 35 months from the start of the trial. Discussion: This is the first stepped-wedge cluster-randomized controlled trial to investigate whether an evidence-based integrated therapeutic approach improves quality of life and

Published
2023

36. Routine vaccination for influenza and pneumococcal disease and its effect on COVID-19 in a population of Dutch older adults

Author

Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Taks, Esther J.M., Föhse, Konstantin, J.C.F.M. Moorlag, Simone, Hoogerwerf, Jacobien, van Crevel, Reinout, van Werkhoven, Cornelis H., Netea, Mihai G., ten Oever, Jaap, Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Taks, Esther J.M., Föhse, Konstantin, J.C.F.M. Moorlag, Simone, Hoogerwerf, Jacobien, van Crevel, Reinout, van Werkhoven, Cornelis H., Netea, Mihai G., and ten Oever, Jaap

Published
2023

37. The impact of Bacillus Calmette-Guérin vaccination on antibody response after COVID-19 vaccination

Author

Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten, Epidemiology of Sepsis & Inflammation in Critically Ill Patients, Epi Infectieziekten Team 1b, Taks, Esther J M, Moorlag, Simone J C F M, Föhse, Konstantin, Simonetti, Elles, van der Gaast-de Jongh, Christa E, van Werkhoven, Cornelis H, Bonten, Marc J M, Oever, Jaap Ten, de Jonge, Marien I, van de Wijgert, Janneke H H M, Netea, Mihai G, Epi Infectieziekten Team 1, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten, Epidemiology of Sepsis & Inflammation in Critically Ill Patients, Epi Infectieziekten Team 1b, Taks, Esther J M, Moorlag, Simone J C F M, Föhse, Konstantin, Simonetti, Elles, van der Gaast-de Jongh, Christa E, van Werkhoven, Cornelis H, Bonten, Marc J M, Oever, Jaap Ten, de Jonge, Marien I, van de Wijgert, Janneke H H M, and Netea, Mihai G

Published
2023

38. Corrigendum: The impact of circadian rhythm on Bacillus Calmette-Guérin vaccination effects on SARS-CoV-2 infections (Front. Immunol., (2023), 14, 980711, 10.3389/fimmu.2023.980711)

Author

Epi Infectieziekten, Infection & Immunity, Epidemiology of Sepsis & Inflammation in Critically Ill Patients, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten Team 1, Föhse, Konstantin, Taks, Esther J M, Moorlag, Simone J C F M, Bonten, Marc J M, van Crevel, Reinout, Ten Oever, Jaap, van Werkhoven, Cornelis H, Netea, Mihai G, van de Maat, Josephine S, Hoogerwerf, Jacobien J, Epi Infectieziekten, Infection & Immunity, Epidemiology of Sepsis & Inflammation in Critically Ill Patients, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten Team 1, Föhse, Konstantin, Taks, Esther J M, Moorlag, Simone J C F M, Bonten, Marc J M, van Crevel, Reinout, Ten Oever, Jaap, van Werkhoven, Cornelis H, Netea, Mihai G, van de Maat, Josephine S, and Hoogerwerf, Jacobien J

Published
2023

39. The impact of circadian rhythm on Bacillus Calmette-Guérin vaccination effects on SARS-CoV-2 infections

Author

Epi Infectieziekten, Infection & Immunity, Epidemiology of Sepsis & Inflammation in Critically Ill Patients, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten Team 1, Föhse, Konstantin, Taks, Esther J M, Moorlag, Simone J C F M, Bonten, Marc J M, van Crevel, Reinout, Ten Oever, Jaap, van Werkhoven, Cornelis H, Netea, Mihai G, van de Maat, Josephine S, Hoogerwerf, Jacobien J, Epi Infectieziekten, Infection & Immunity, Epidemiology of Sepsis & Inflammation in Critically Ill Patients, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten Team 1, Föhse, Konstantin, Taks, Esther J M, Moorlag, Simone J C F M, Bonten, Marc J M, van Crevel, Reinout, Ten Oever, Jaap, van Werkhoven, Cornelis H, Netea, Mihai G, van de Maat, Josephine S, and Hoogerwerf, Jacobien J

Published
2023

40. Positive impact of [18F]FDG-PET/CT on mortality in patients with Staphylococcus aureus bacteremia explained by immortal time bias

Author

Infection & Immunity, Epi Infectieziekten Team 1, JC onderzoeksprogramma Infectious Diseases, Epi Infectieziekten, Epidemiology of Sepsis & Inflammation in Critically Ill Patients, van der Vaart, Thomas W, Prins, Jan M, van Werkhoven, Cornelis H, Ten Doesschate, Thijs, Soetekouw, Robin, van Twillert, Gitte, Veenstra, Jan, Herpers, Bjorn L, Rozemeijer, Wouter, Jansen, Rogier R, Bonten, Marc J M, van der Meer, Jan T M, Infection & Immunity, Epi Infectieziekten Team 1, JC onderzoeksprogramma Infectious Diseases, Epi Infectieziekten, Epidemiology of Sepsis & Inflammation in Critically Ill Patients, van der Vaart, Thomas W, Prins, Jan M, van Werkhoven, Cornelis H, Ten Doesschate, Thijs, Soetekouw, Robin, van Twillert, Gitte, Veenstra, Jan, Herpers, Bjorn L, Rozemeijer, Wouter, Jansen, Rogier R, Bonten, Marc J M, and van der Meer, Jan T M

Published
2023

43. BCG Vaccination of Health Care Workers Does Not Reduce SARS-CoV-2 Infections nor Infection Severity or Duration: a Randomized Placebo-Controlled Trial

Author

Claus, Juana, Ten Doesschate, Thijs, Gumbs, Cheyenne, van Werkhoven, Cornelis H, van der Vaart, Thomas W, Janssen, Axel B, Smits, Gaby, van Binnendijk, Rob, van der Klis, Fiona, van Baarle, Debbie, Paganelli, Fernanda L, Leavis, Helen, Verhagen, Lilly M, Joosten, Simone A, Bonten, Marc J M, Netea, Mihai G, and van de Wijgert, Janneke H H M

Subjects
randomized placebo-controlled clinical trial, Bacillus Calmette-Guerin vaccine, SARS-CoV-2, COVID-19, health care workers
Abstract

Bacillus Calmette-Guerin (BCG) vaccination has been hypothesized to reduce severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, severity, and/or duration via trained immunity induction. Health care workers (HCWs) in nine Dutch hospitals were randomized to BCG or placebo vaccination (1:1) in March and April 2020 and followed for 1 year. They reported daily symptoms, SARS-CoV-2 test results, and health care-seeking behavior via a smartphone application, and they donated blood for SARS-CoV-2 serology at two time points. A total of 1,511 HCWs were randomized and 1,309 analyzed (665 BCG and 644 placebo). Of the 298 infections detected during the trial, 74 were detected by serology only. The SARS-CoV-2 incidence rates were 0.25 and 0.26 per person-year in the BCG and placebo groups, respectively (incidence rate ratio, 0.95; 95% confidence interval, 0.76 to 1.21; P = 0.732). Only three participants required hospitalization for SARS-CoV-2. The proportions of participants with asymptomatic, mild, or moderate infections and the mean infection durations did not differ between randomization groups. In addition, unadjusted and adjusted logistic regression and Cox proportional hazards models showed no differences between BCG and placebo vaccination for any of these outcomes. The percentage of participants with seroconversion (7.8% versus 2.8%; P = 0.006) and mean SARS-CoV-2 anti-S1 antibody concentration (13.1 versus 4.3 IU/mL; P = 0.023) were higher in the BCG than placebo group at 3 months but not at 6 or 12 months postvaccination. BCG vaccination of HCWs did not reduce SARS-CoV-2 infections nor infection duration or severity (ranging from asymptomatic to moderate). In the first 3 months after vaccination, BCG vaccination may enhance SARS-CoV-2 antibody production during SARS-CoV-2 infection. IMPORTANCE While several BCG trials in adults were conducted during the 2019 coronavirus disease epidemic, our data set is the most comprehensive to date, because we included serologically confirmed infections in addition to self-reported positive SARS-CoV-2 test results. We also collected data on symptoms for every day during the 1-year follow-up period, which enabled us to characterize infections in detail. We found that BCG vaccination did not reduce SARS-CoV-2 infections nor infection duration or severity but may have enhanced SARS-CoV-2 antibody production during SARS-CoV-2 infection in the first 3 months after vaccination. These results are in agreement with other BCG trials that reported negative results (but did not use serological endpoints), except for two trials in Greece and India that reported positive results but had few endpoints and included endpoints that were not laboratory confirmed. The enhanced antibody production is in agreement with prior mechanistic studies but did not translate into protection from SARS-CoV-2 infection.

Published
2023

45. The impact of circadian rhythm on Bacillus Calmette-Guérin vaccination effects on SARS-CoV-2 infections

Author

Föhse, Konstantin, primary, Taks, Esther J.M., additional, Moorlag, Simone J. C. F. M., additional, Bonten, Marc J. M., additional, van Crevel, Reinout, additional, ten Oever, Jaap, additional, van Werkhoven, Cornelis H., additional, Netea, Mihai G., additional, van de Maat, Josephine S., additional, and Hoogerwerf, Jacobien J., additional

Published
2023
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50. The impact of circadian rhythm on Bacillus Calmette-Gue'rin vaccination effects on SARSCoV-2 infections.

Author

Föhse, Konstantin, Taks, Esther J. M., Moorlag, Simone J. C. F. M., Bonten, Marc J. M., van Crevel, Reinout, Oever, Jaap ten, van Werkhoven, Cornelis H., Netea, Mihai G., van de Maat, Josephine S., and Hoogerwerf, Jacobien J.

Subjects
CIRCADIAN rhythms, BACILLUS (Bacteria), BCG vaccines, RESPIRATORY infections, VACCINATION
Abstract

Background and objective: A recent study has suggested that circadian rhythm has an important impact on the immunological effects induced by Bacillus Calmette-Gue'rin (BCG) vaccination. The objective of this study was to evaluate whether the timing of BCG vaccination (morning or afternoon) affects its impact on severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infections and clinically relevant respiratory tract infections (RTIs). Methods: This is a post-hoc analysis of the BCG-CORONA-ELDERLY (NCT04417335) multicenter, placebo-controlled trial, in which participants aged 60 years and older were randomly assigned to vaccination with BCG or placebo, and followed for 12 months. The primary endpoint was the cumulative incidence of SARS-CoV-2 infection. To assess the impact of circadian rhythm on the BCG effects, participants were divided into four groups: vaccinated with either BCG or placebo in the morning (between 9:00h and 11:30h) or in the afternoon (between 14:30h and 18:00h). Results: The subdistribution hazard ratio of SARS-CoV-2 infection in the first six months after vaccination was 2.394 (95% confidence interval [CI], 0.856-6.696) for the morning BCG group and 0.284 (95% CI, 0.055-1.480) for the afternoon BCG group. When comparing those two groups, the interaction hazard ratio was 8.966 (95% CI, 1.366-58.836). In the period from six months until 12 months after vaccination cumulative incidences of SARS-CoV-2 infection were comparable, as well as cumulative incidences of clinically relevant RTI in both periods. Conclusion: Although there was a difference in effect between morning and afternoon BCG vaccination, the vaccine did not protect against SARS-COV-2 infections and clinically relevant RTI's at either timepoint. [ABSTRACT FROM AUTHOR]

Published
2023
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