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1. Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial

Author

Lovesio, Luciano, Diez, Fabián, Grazziani, Franco, Ganaha, Maria Cristina, Zalatnik, Viviana Judith, Dittrich, Ricardo Julio, Espínola, Lidia, Lambert, Sandra, Longhi, Andrea, Vecchio, Claudia, Mastruzzo, María, Fernandez, Alberto, Borchowiek, Silvina, Potito, Roberto, Ahuad Guerrero, Rodolfo Andres, Guardiani, Fernando Martin, Castella, Sofia, Foccoli, Monica, Pedernera, Aldana, Braida, Ariel, Durigan, Virginia, Martella, Carolina, Bobat, Antonela, Boggia, Bruno Emilio, Nemi, Sergio Andrés, Tartaglione, Javier Gerardo, Piedimonte, Fabián César, De Bie, Jessie, Reynales Londoño, Humberto, Rodríguez Ordoñez, Paula Andrea, García Cruz, Johanna Marcela, Bautista Toloza, Leonardo, Ladino González, Margot Cecilia, Zambrano Ochoa, Adriana Pilar, Prieto Pradera, Iñigo, Torres Hernandez, Daniela, Mazo Elorza, Diana Patricia, Collazos Lennis, Maria Fernanda, Vanegas Dominguez, Beatriz, Solano Mosquera, Lina Marianur, Fendel, Rolf, Fleischmann, Wim Alexander, Koehne, Erik, Kreidenweiss, Andrea, Köhler, Carsten, Esen, Meral, Horn, Carola, Eberts, Sandra, Kroidl, Arne, Huber, Kristina, Thiel, Verena, Mazara Rosario, Sonia, Reyes, Gilda, Rivera, Laura, Donastorg, Yeycy, Lantigua, Flavia, Torres Almanzar, Dania, Candelario, Rosalba, Peña Mendez, Lourdes, Rosario Gomez, Nadia, Portolés-Pérez, Antonio, Ascaso del Río, Ana, Laredo Velasco, Leonor, Bustinduy Odriozola, Maria Jesus, Larrea Arranz, Igor, Martínez Alcorta, Luis Ignacio, Durán Laviña, María Isabel, Imaz-Ayo, Natale, Meijide, Susana, García-de-Vicuña, Aitor, Santorcuato, Ana, Gallego, Mikel, Aguirre-García, Gloria Mayela, Olmos Vega, Jocelyn, González Limón, Pablo, Vázquez Villar, Andrea, Chávez Barón, Jaime, Arredondo Saldaña, Felipe, Luján Palacios, Juan de Dios, Camacho Choza, Laura Julia, Vázquez Saldaña, Eduardo Gabriel, Ortega Dominguez, Sandra Janeth, Vega Orozco, Karen Sofia, Torres Quiroz, Ivonne Aimee, Martinez Avendaño, Alejandro, Herrera Sanchez, Javier, Guzman, Esperanza, Castro Castrezana, Laura, Ruiz Palacios y Santos, Guillermo Miguel, de Winter, Ronald Frank Jacobus, de Jonge, Hanna K, Schnyder, Jenny L, Boersma, Wim, Hessels, Lisa, Djamin, Remco, van der Sar, Simone, DeAntonio, Rodrigo, Peña, Moisés, Rebollon, Gabriel, Rojas, Marianela, Escobar, Johnny, Hammerschlag Icaza, Bruno, Wong T, Digna Y, Barrera Perigault, Paulo, Ruiz, Sergio, Chan, Milagros, Arias Hoo, Dommie Janneth, Gil, Ana I, Celis, Carlos R, Balmaceda, Maria Pia, Flores, Omar, Ochoa, Mayra, Peña, Bia, de la Flor, Carolina, Webb, Camille María, Cornejo, Enrique, Sanes, Fatima, Mayorga, Valerie, Valdiviezo, Gladys, Ramírez Lamas, Suzanne Pamela, Grandez Castillo, Gustavo Alberto, Lama, Javier R, Matta Aguirre, Milagros Erika, Arancibia Luna, Lesly Angela, Carbajal Paulet, Óscar, Zambrano Ortiz, José, Camara, Anais, Guzman Quintanilla, Fernanda, Diaz-Parra, Carmen, Morales-Oliva, Jose, Cornejo, Rubelio E, Ricalde, Sheby A, Vidal, Jhonny, Rios Nogales, Luis, Cheatham-Seitz, Darline, Gregoraci, Giorgia, Brecx, Alain, Walz, Lisa, Vahrenhorst, Dominik, Seibel, Tobias, Quintini, Gianluca, Kremsner, Peter G, Ahuad Guerrero, Rodolfo Andrés, Arana-Arri, Eunate, Aroca Martinez, Gustavo Jose, Bonten, Marc, Chandler, Reynaldo, Corral, Gonzalo, De Block, Eddie Jan Louis, Ecker, Lucie, Gabor, Julian Justin, Garcia Lopez, Carlos Alberto, Gonzales, Lucy, Granados González, María Angélica, Gorini, Nestor, Grobusch, Martin P, Hrabar, Adrian D, Junker, Helga, Kimura, Alan, Lanata, Claudio F, Lehmann, Clara, Leroux-Roels, Isabel, Mann, Philipp, Martinez-Reséndez, Michel Fernando, Ochoa, Theresa J, Poy, Carlos Alberto, Reyes Fentanes, Maria Jose, Rivera Mejia, Luis Maria, Ruiz Herrera, Vida Veronica, Sáez-Llorens, Xavier, Schönborn-Kellenberger, Oliver, Schunk, Mirjam, Sierra Garcia, Alexandra, Vergara, Itziar, Verstraeten, Thomas, Vico, Marisa, and Oostvogels, Lidia

Published
2022
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2. Norovirus acute gastroenteritis amongst US and European travellers to areas of moderate to high risk of travellers' diarrhoea: a prospective cohort study.

Author

Alberer, Martin, Moe, Christine L, Hatz, Christoph, Kling, Kerstin, Kirby, Amy E, Lindsay, Lisa, Nothdurft, Hans D, Riera-Montes, Margarita, Steffen, Robert, Verstraeten, Thomas, Wu, Henry M, and DuPont, Herbert L

Subjects
VIRAL gastroenteritis, MIDDLE-income countries, VACCINE development, GASTROENTERITIS, TRAVEL planning
Abstract

Background Acute gastroenteritis (AGE) is a major medical condition for travellers worldwide, particularly travellers to low- and middle-income countries. Norovirus (NoV) is the most common cause of viral AGE in older children and adults, but data on prevalence and impact amongst travellers is limited. Methods Prospective, multi-site, observational cohort study conducted 2015–2017, amongst adult international travellers from the US and Europe to areas of moderate to high risk of travel-acquired AGE. Participants provided self-collected pre-travel stool samples and self-reported AGE symptoms whilst travelling. Post-travel stool samples were requested from symptomatic subjects and a sample of asymptomatic travellers within 14 days of return. Samples were tested for NoV by RT-qPCR, genotyped if positive and tested for other common enteric pathogens by Luminex xTAG GPP. Results Of the 1109 participants included, 437 (39.4%) developed AGE symptoms resulting in an overall AGE incidence of 24.7 per 100 person-weeks [95% confidence interval (CI): 22.4; 27.1]. In total, 20 NoV-positive AGE cases (5.2% of those tested) were identified at an incidence of 1.1 per 100 person-weeks (95% CI: 0.7; 1.7). NoV-positive samples belonged mostly to genogroup GII (18, 85.7%); None of the 13 samples sequenced belonged to genotype GII.4. Clinical severity of AGE was higher for NoV-positive than for NoV-negative cases (mean modified Vesikari Score 6.8 vs 4.9) with more cases classified as severe or moderate (25% vs 6.8%). In total, 80% of NoV-positive participants (vs 38.9% in NoV-negative) reported at least moderate impact on travel plans. Conclusions AGE is a prevalent disease amongst travellers with a small proportion associated with NoV. Post-travel stool sample collection timing might have influenced the low number of NoV cases detected; however, NoV infections resulted in high clinical severity and impact on travel plans. These results may contribute to targeted vaccine development and the design of future studies on NoV epidemiology. [ABSTRACT FROM AUTHOR]

Published
2024
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5. A prospective cohort study of SARS-CoV-2 infection-induced seroconversion and disease incidence in German healthcare workers before and during the rollout of COVID-19 vaccines

Author

Gehring, Stephan, primary, Kowalzik, Frank, additional, Okasha, Omar, additional, Engelmann, Tobias, additional, Schreiner, Daniel, additional, Jensen, Christian, additional, Mähringer-Kunz, Aline, additional, Hartig-Merkel, Wendy, additional, Mai Phuong Tran, Thao, additional, Oostvogels, Cornelia, additional, and Verstraeten, Thomas, additional

Published
2024
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7. Norovirus acute gastroenteritis among US and European travellers to areas of moderate to high risk of travellers' diarrhoea: a prospective cohort study

Author

Alberer, Martin, Moe, Christine L, Hatz, Christoph, Kling, Kerstin, Kirby, Amy E, Lindsay, Lisa, Nothdurft, Hans Dieter, Riera-Montes, Margarita, Steffen, Robert, Verstraeten, Thomas, Wu, Henry M, DuPont, Herbert L, Alberer, Martin, Moe, Christine L, Hatz, Christoph, Kling, Kerstin, Kirby, Amy E, Lindsay, Lisa, Nothdurft, Hans Dieter, Riera-Montes, Margarita, Steffen, Robert, Verstraeten, Thomas, Wu, Henry M, and DuPont, Herbert L

Abstract

BACKGROUND Acute gastroenteritis (AGE) is a major medical condition for travellers worldwide, particularly travellers to low- and middle-income countries. Norovirus (NoV) is the most common cause of viral AGE in older children and adults, but data on prevalence and impact among travellers is limited. METHODS Prospective, multi-site, observational cohort study conducted 2015-2017, among adult international travellers from the US and Europe to areas of moderate to high risk of travel-acquired AGE. Participants provided self-collected pre-travel stool samples and self-reported AGE symptoms while travelling. Post-travel stool samples were requested from symptomatic subjects and a sample of asymptomatic travellers within 14days of return. Samples were tested for NoV by RT-qPCR, genotyped if positive, and tested for other common enteric pathogens by Luminex xTAG GPP. RESULTS Of the 1109 participants included, 437 (39.4%) developed AGE symptoms resulting in an overall AGE incidence of 24.7 per 100 person-weeks (95% CI: 22.4; 27.1). Twenty NoV-positive AGE cases (5.2% of those tested) were identified at an incidence of 1.1 per 100 person-weeks (95% CI: 0.7; 1.7). NoV-positive samples belonged mostly to genogroup GII (18, 85.7%); None of the 13 samples sequenced belonged to genotype GII.4. Clinical severity of AGE was higher for NoV-positive than for NoV-negative cases (mean modified Vesikari Score 6.8 vs 4.9) with more cases classified as severe or moderate (25% vs 6.8%). Eighty percent of NoV-positive participants (vs. 38.9% in NoV-negative) reported at least moderate impact on travel plans. CONCLUSIONS AGE is a prevalent disease among travellers with a small proportion associated with NoV. Post-travel stool sample collection timing might have influenced the low number of NoV cases detected; however, NoV infections resulted in high clinical severity and impact on travel plans. These results may contribute to targeted vaccine development and the design of future studies on

Published
2023

14. Norovirus acute gastroenteritis among US and European travellers to areas of moderate to high risk of travellers’ diarrhoea: a prospective cohort study

Author

Alberer, Martin, primary, Moe, Christine L, additional, Hatz, Christoph, additional, Kling, Kerstin, additional, Kirby, Amy E, additional, Lindsay, Lisa, additional, Nothdurft, Hans Dieter, additional, Riera-Montes, Margarita, additional, Steffen, Robert, additional, Verstraeten, Thomas, additional, Wu, Henry M, additional, and DuPont, Herbert L, additional

Published
2023
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18. Real-world impact and effectiveness of the quadrivalent HPV vaccine: an updated systematic literature review

Author

Wang, Wei (Vivian), primary, Kothari, Smita, additional, Skufca, Jozica, additional, Giuliano, Anna R., additional, Sundström, Karin, additional, Nygård, Mari, additional, Koro, Carol, additional, Baay, Marc, additional, Verstraeten, Thomas, additional, Luxembourg, Alain, additional, Saah, Alfred J., additional, and Garland, Suzanne M., additional

Published
2022
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19. Effectiveness of the Fiocruz recombinant ChadOx1-nCoV19 against variants of SARS-CoV-2 in the Municipality of Botucatu-SP

Author

Costa Clemens, Sue Ann, primary, Fortaleza, Carlos Magno Castelo Branco, additional, Crowe, Madeleine, additional, Tasca, Karen Ingrid, additional, Spadaro, André Gasparini, additional, Souza-Neto, Jayme Augusto, additional, Grotto, Rejane Maria Tommasini, additional, Sider, Regina, additional, Jimeno, Jose, additional, Verstraeten, Thomas, additional, and Clemens, Ralf, additional

Published
2022
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21. Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial

Author

Kremsner, Peter G., Ahuad Guerrero, Rodolfo Andres, Arana-Arri, Eunate, Aroca Martinez, Gustavo Jose, Bonten, Marc, Chandler, Reynaldo, Corral, Gonzalo, Louis De Block, Eddie Jan, Ecker, Lucie, Justin Gabor, Julian, Garcia Lopez, Carlos Alberto, Gonzales, Lucy, Granados Gonzalez, Maria Angelica, Gorini, Nestor, Grobusch, Martin P., Hrabar, Adrian D., Junker, Helga, Kimura, Alan, Lanata, Claudio F., Lehmann, Clara, Leroux-Roels, Isabel, Mann, Philipp, Fernando Martinez-Resendez, Michel, Ochoa, Theresa J., Alberto Poy, Carlos, Reyes Fentanes, Maria Jose, Rivera Mejia, Luis Maria, Ruiz Herrera, Vida Veronica, Saez-Llorens, Xavier, Schoenborn-Kellenberger, Oliver, Schunk, Mirjam, Sierra Garcia, Alexandra, Vergara, Itziar, Verstraeten, Thomas, Vico, Marisa, Oostvogels, Lidia, Kremsner, Peter G., Ahuad Guerrero, Rodolfo Andres, Arana-Arri, Eunate, Aroca Martinez, Gustavo Jose, Bonten, Marc, Chandler, Reynaldo, Corral, Gonzalo, Louis De Block, Eddie Jan, Ecker, Lucie, Justin Gabor, Julian, Garcia Lopez, Carlos Alberto, Gonzales, Lucy, Granados Gonzalez, Maria Angelica, Gorini, Nestor, Grobusch, Martin P., Hrabar, Adrian D., Junker, Helga, Kimura, Alan, Lanata, Claudio F., Lehmann, Clara, Leroux-Roels, Isabel, Mann, Philipp, Fernando Martinez-Resendez, Michel, Ochoa, Theresa J., Alberto Poy, Carlos, Reyes Fentanes, Maria Jose, Rivera Mejia, Luis Maria, Ruiz Herrera, Vida Veronica, Saez-Llorens, Xavier, Schoenborn-Kellenberger, Oliver, Schunk, Mirjam, Sierra Garcia, Alexandra, Vergara, Itziar, Verstraeten, Thomas, Vico, Marisa, and Oostvogels, Lidia

Abstract

Background Additional safe and efficacious vaccines are needed to control the COVID-19 pandemic. We aimed to analyse the efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate. Methods HERALD is a randomised, observer-blinded, placebo-controlled, phase 2b/3 clinical trial conducted in 47 centres in ten countries in Europe and Latin America. By use of an interactive web response system and stratification by country and age group (18-60 years and >= 61 years), adults with no history of virologically confirmed COVID-19 were randomly assigned (1:1) to receive intramuscularly either two 0.6 mL doses of CVnCoV containing 12 mu g of mRNA or two 0.6 mL doses of 0.9% NaCl (placebo) on days 1 and 29. The primary efficacy endpoint was the occurrence of a first episode of virologically confirmed symptomatic COVID-19 of any severity and caused by any strain from 15 days after the second dose. For the primary endpoint, the trial was considered successful if the lower limit of the CI was greater than 30%. Key secondary endpoints were the occurrence of a first episode of virologically confirmed moderate-to-severe COVID-19, severe COVID-19, and COVID-19 of any severity by age group. Primary safety outcomes were solicited local and systemic adverse events within 7 days after each dose and unsolicited adverse events within 28 days after each dose in phase 2b participants, and serious adverse events and adverse events of special interest up to 1 year after the second dose in phase 2b and phase 3 participants. Here, we report data up to June 18, 2021. The study is registered at ClinicalTrials.gov, NCT04652102, and EudraCT, 2020-003998-22, and is ongoing. Findings Between Dec 11, 2020, and April 12, 2021, 39 680 participants were enrolled and randomly assigned to receive either CVnCoV (n=19 846) or placebo (n=19 834), of whom 19 783 received at least one dose of CVnCoV and 19 746 received at least one dose of placebo. After a mean observation period of 48.2 days (SE 0.2), 83

Published
2022

22. Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial

Author

Kremsner, Peter G, primary, Ahuad Guerrero, Rodolfo Andrés, additional, Arana-Arri, Eunate, additional, Aroca Martinez, Gustavo Jose, additional, Bonten, Marc, additional, Chandler, Reynaldo, additional, Corral, Gonzalo, additional, De Block, Eddie Jan Louis, additional, Ecker, Lucie, additional, Gabor, Julian Justin, additional, Garcia Lopez, Carlos Alberto, additional, Gonzales, Lucy, additional, Granados González, María Angélica, additional, Gorini, Nestor, additional, Grobusch, Martin P, additional, Hrabar, Adrian D, additional, Junker, Helga, additional, Kimura, Alan, additional, Lanata, Claudio F, additional, Lehmann, Clara, additional, Leroux-Roels, Isabel, additional, Mann, Philipp, additional, Martinez-Reséndez, Michel Fernando, additional, Ochoa, Theresa J, additional, Poy, Carlos Alberto, additional, Reyes Fentanes, Maria Jose, additional, Rivera Mejia, Luis Maria, additional, Ruiz Herrera, Vida Veronica, additional, Sáez-Llorens, Xavier, additional, Schönborn-Kellenberger, Oliver, additional, Schunk, Mirjam, additional, Sierra Garcia, Alexandra, additional, Vergara, Itziar, additional, Verstraeten, Thomas, additional, Vico, Marisa, additional, Oostvogels, Lidia, additional, Lovesio, Luciano, additional, Diez, Fabián, additional, Grazziani, Franco, additional, Ganaha, Maria Cristina, additional, Zalatnik, Viviana Judith, additional, Dittrich, Ricardo Julio, additional, Espínola, Lidia, additional, Lambert, Sandra, additional, Longhi, Andrea, additional, Vecchio, Claudia, additional, Mastruzzo, María, additional, Fernandez, Alberto, additional, Borchowiek, Silvina, additional, Potito, Roberto, additional, Ahuad Guerrero, Rodolfo Andres, additional, Guardiani, Fernando Martin, additional, Castella, Sofia, additional, Foccoli, Monica, additional, Pedernera, Aldana, additional, Braida, Ariel, additional, Durigan, Virginia, additional, Martella, Carolina, additional, Bobat, Antonela, additional, Boggia, Bruno Emilio, additional, Nemi, Sergio Andrés, additional, Tartaglione, Javier Gerardo, additional, Piedimonte, Fabián César, additional, De Bie, Jessie, additional, Reynales Londoño, Humberto, additional, Rodríguez Ordoñez, Paula Andrea, additional, García Cruz, Johanna Marcela, additional, Bautista Toloza, Leonardo, additional, Ladino González, Margot Cecilia, additional, Zambrano Ochoa, Adriana Pilar, additional, Prieto Pradera, Iñigo, additional, Torres Hernandez, Daniela, additional, Mazo Elorza, Diana Patricia, additional, Collazos Lennis, Maria Fernanda, additional, Vanegas Dominguez, Beatriz, additional, Solano Mosquera, Lina Marianur, additional, Fendel, Rolf, additional, Fleischmann, Wim Alexander, additional, Koehne, Erik, additional, Kreidenweiss, Andrea, additional, Köhler, Carsten, additional, Esen, Meral, additional, Horn, Carola, additional, Eberts, Sandra, additional, Kroidl, Arne, additional, Huber, Kristina, additional, Thiel, Verena, additional, Mazara Rosario, Sonia, additional, Reyes, Gilda, additional, Rivera, Laura, additional, Donastorg, Yeycy, additional, Lantigua, Flavia, additional, Torres Almanzar, Dania, additional, Candelario, Rosalba, additional, Peña Mendez, Lourdes, additional, Rosario Gomez, Nadia, additional, Portolés-Pérez, Antonio, additional, Ascaso del Río, Ana, additional, Laredo Velasco, Leonor, additional, Bustinduy Odriozola, Maria Jesus, additional, Larrea Arranz, Igor, additional, Martínez Alcorta, Luis Ignacio, additional, Durán Laviña, María Isabel, additional, Imaz-Ayo, Natale, additional, Meijide, Susana, additional, García-de-Vicuña, Aitor, additional, Santorcuato, Ana, additional, Gallego, Mikel, additional, Aguirre-García, Gloria Mayela, additional, Olmos Vega, Jocelyn, additional, González Limón, Pablo, additional, Vázquez Villar, Andrea, additional, Chávez Barón, Jaime, additional, Arredondo Saldaña, Felipe, additional, Luján Palacios, Juan de Dios, additional, Camacho Choza, Laura Julia, additional, Vázquez Saldaña, Eduardo Gabriel, additional, Ortega Dominguez, Sandra Janeth, additional, Vega Orozco, Karen Sofia, additional, Torres Quiroz, Ivonne Aimee, additional, Martinez Avendaño, Alejandro, additional, Herrera Sanchez, Javier, additional, Guzman, Esperanza, additional, Castro Castrezana, Laura, additional, Ruiz Palacios y Santos, Guillermo Miguel, additional, de Winter, Ronald Frank Jacobus, additional, de Jonge, Hanna K, additional, Schnyder, Jenny L, additional, Boersma, Wim, additional, Hessels, Lisa, additional, Djamin, Remco, additional, van der Sar, Simone, additional, DeAntonio, Rodrigo, additional, Peña, Moisés, additional, Rebollon, Gabriel, additional, Rojas, Marianela, additional, Escobar, Johnny, additional, Hammerschlag Icaza, Bruno, additional, Wong T, Digna Y, additional, Barrera Perigault, Paulo, additional, Ruiz, Sergio, additional, Chan, Milagros, additional, Arias Hoo, Dommie Janneth, additional, Gil, Ana I, additional, Celis, Carlos R, additional, Balmaceda, Maria Pia, additional, Flores, Omar, additional, Ochoa, Mayra, additional, Peña, Bia, additional, de la Flor, Carolina, additional, Webb, Camille María, additional, Cornejo, Enrique, additional, Sanes, Fatima, additional, Mayorga, Valerie, additional, Valdiviezo, Gladys, additional, Ramírez Lamas, Suzanne Pamela, additional, Grandez Castillo, Gustavo Alberto, additional, Lama, Javier R, additional, Matta Aguirre, Milagros Erika, additional, Arancibia Luna, Lesly Angela, additional, Carbajal Paulet, Óscar, additional, Zambrano Ortiz, José, additional, Camara, Anais, additional, Guzman Quintanilla, Fernanda, additional, Diaz-Parra, Carmen, additional, Morales-Oliva, Jose, additional, Cornejo, Rubelio E, additional, Ricalde, Sheby A, additional, Vidal, Jhonny, additional, Rios Nogales, Luis, additional, Cheatham-Seitz, Darline, additional, Gregoraci, Giorgia, additional, Brecx, Alain, additional, Walz, Lisa, additional, Vahrenhorst, Dominik, additional, Seibel, Tobias, additional, and Quintini, Gianluca, additional

Published
2022
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24. Real-world impact and effectiveness assessment of the quadrivalent HPV vaccine: a systematic review of study designs and data sources

Author

Wang, Wei, primary, Kothari, Smita, additional, Baay, Marc, additional, Garland, Suzanne M., additional, Giuliano, Anna R., additional, Nygård, Mari, additional, Velicer, Christine, additional, Tota, Joseph, additional, Sinha, Anushua, additional, Skufca, Jozica, additional, Verstraeten, Thomas, additional, and Sundström, Karin, additional

Published
2021
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25. An Epidemiological Cohort Study of SARS-CoV-2 and COVID-19 in German Healthcare Workers – Interim Analysis after Six Months of Follow-up

Author

Gehring, Stephan, primary, Okasha, Omar, additional, Kowalzik, Frank, additional, Engelmann, Tobias, additional, Schreiner, Daniel, additional, Jensen, Christian, additional, Maehringer-Kunz, Aline, additional, Hartig-Merkel, Wendy, additional, Tomer, Anirudh, additional, Oostvogels, Lidia, additional, and Verstraeten, Thomas, additional

Published
2021
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27. Additional file 1 of Model estimates of hospitalization discharge rates for norovirus gastroenteritis in Europe, 2004–2015

Author

Calduch, Elsa Negro, Cattaert, Tom, and Verstraeten, Thomas

Abstract

Additional file 1. Table S1. Clinical coding grouping. Table S2. Registers that provided national hospital discharge statistics to the present study. Table S3. Non-included countries in Europe: data provider contacted and reason for exclusion. Table S4. Mean annual number and mean annual rate of hospital discharges for all-cause acute gastroenteritis as first-listed diagnosis in participating European countries between 2004 and 2015. Table S5. Goodness of fit. Table S6. List of Data Providers / Requirements.

Published
2021
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28. Estimation of Risk of Death Attributable to Acute Gastroenteritis Not Caused by Clostridioides difficile Infection Among Hospitalized Adults in England

Author

Alexandridou,Maria, Cattaert,Tom, Verstraeten,Thomas, Alexandridou,Maria, Cattaert,Tom, and Verstraeten,Thomas

Abstract

Maria Alexandridou, Tom Cattaert, Thomas Verstraeten P95 Pharmacovigilance and Epidemiology Services, Leuven, BelgiumCorrespondence: Thomas Verstraeten Email thomas.verstraeten@p-95.comIntroduction: The role of an infectious agent may be unclear as the primary cause of death. Furthermore, many infections go undiagnosed, particularly if identification does not affect treatment. To circumvent the limitations of individual death attribution, a population-level assessment of the role of infectious acute gastroenteritis (AGE) was performed.Methods: Using the Clinical Practice Research Datalink and the Office for National Statistics – Mortality Statistics, covering 16 million patients in the UK, we conducted a matched case–control study to estimate the odds of having AGE not due to Clostridioides difficile infection (CDI) diagnosed in the month before death among hospitalized adults in England. To estimate the number of deaths, we first estimated the attributable fraction (AF). The population attributable fraction (PAF) was then derived by multiplying AF with the proportion of AGE hospitalizations among all hospitalizations. Finally, by multiplying the PAF with the number of deaths, the number of deaths attributable to AGE not caused by CDI among hospitalized patients was estimated.Results: The odds of having AGE not caused by CDI was 4.6 times higher among fatal compared to non-fatal hospitalizations. The overall PAF was 1.7% for AGE not caused by CDI. The overall number of deaths attributable to AGE not caused by CDI among adults in England is estimated to be 5000 annually.Discussion: Approximately 5000 of the 276,000 deaths that occur annually among hospitalized adults in England can be attributed to AGE not caused by CDI, which is higher than previously estimated.Keywords: acute gastroenteritis, CPRD, England, population attributable fraction

Published
2021

29. Reply to Baird and Douglas

Author

Epi Infectieziekten, MMB, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Bonten, Marc, Verstraeten, Thomas, Gravenstein, Stefan, Poolman, Jan, Epi Infectieziekten, MMB, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Bonten, Marc, Verstraeten, Thomas, Gravenstein, Stefan, and Poolman, Jan

Published
2021

30. Epidemiology of Escherichia coli Bacteremia: A Systematic Literature Review

Author

Epi Infectieziekten, MMB, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Bonten, Marc, Johnson, James R, van den Biggelaar, Anita H J, Georgalis, Leonidas, Geurtsen, Jeroen, de Palacios, Patricia Ibarra, Gravenstein, Stefan, Verstraeten, Thomas, Hermans, Peter, Poolman, Jan T, Epi Infectieziekten, MMB, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Bonten, Marc, Johnson, James R, van den Biggelaar, Anita H J, Georgalis, Leonidas, Geurtsen, Jeroen, de Palacios, Patricia Ibarra, Gravenstein, Stefan, Verstraeten, Thomas, Hermans, Peter, and Poolman, Jan T

Published
2021

34. Estimating the incidence of norovirus acute gastroenteritis among US and European international travelers to areas of moderate to high risk of traveler's diarrhea: a prospective cohort study protocol

Author

Lindsay, Lisa; https://orcid.org/0000-0002-4999-1402, DuPont, Herbert L, Moe, Christine L, Alberer, Martin, Hatz, Christoph, Kirby, Amy E, Wu, Henry M, Verstraeten, Thomas, Steffen, Robert, Lindsay, Lisa; https://orcid.org/0000-0002-4999-1402, DuPont, Herbert L, Moe, Christine L, Alberer, Martin, Hatz, Christoph, Kirby, Amy E, Wu, Henry M, Verstraeten, Thomas, and Steffen, Robert

Abstract

BACKGROUND Acute gastroenteritis (AGE) is the leading cause of illness among returning travelers seeking medical care. Multiple types of enteric pathogens can cause travel-acquired AGE and, while bacterial pathogens have a predominant role, the importance of viruses, such as norovirus, is increasingly recognized. There is a lack of information on travel-acquired norovirus incidence among symptomatic and asymptomatic individuals irrespective of healthcare-seeking behavior. Our aim is to estimate the incidence of travel-acquired AGE due to norovirus and to characterize the burden of disease among international travelers from the United States and Europe. METHODS We describe a prospective cohort study implemented in five US and European sites to estimate the role of AGE due to norovirus among adult international travelers. We enrolled individuals aged 18 years and older who are traveling to regions of moderate-high risk of AGE, or via cruise ship with an international port stop, with a trip duration of 3-15 days. The study will generate a wide range of health and travel-related data for pre-, during, and up to 6-months post-travel. We will identify laboratory-confirmed travel-acquired norovirus infections among both symptomatic and asymptomatic individuals from self-collected whole stool samples tested via quantitative RT-PCR. Coinfections will be identified in a subset of travelers with AGE using a multiplex molecular-based assay. DISCUSSION This study is unique in design and breadth of data collected. The prospective collection of health and behavioral data, as well as biologic samples from travelers irrespective of symptoms, will provide useful data to better understand the importance of norovirus AGE among international travelers. This study will provide data to estimate the incidence of norovirus infections and AGE and the risk of post-infectious sequelae in the 6-month post-travel period serving as a baseline for future norovirus AGE vaccination studies. This stu

Published
2018

35. Hepatitis B virus infection and the risk of liver disease progression in type 2 diabetic patients with potential nonalcoholic fatty liver disease: a retrospective, observational, cohort study in the United Kingdom Clinical Practice Research Datalink.

Author

UCL - SSS/IREC/ECLI - Pôle d'Essais cliniques, UCL - (SLuc) Service de gastro-entérologie, Ferreira, Germano, Stuurman, Anke L, Horsmans, Yves, Cattaert, Tom, Verstraeten, Thomas, Feng, Yang, Rosillon, Dominique, Guignard, Adrienne, UCL - SSS/IREC/ECLI - Pôle d'Essais cliniques, UCL - (SLuc) Service de gastro-entérologie, Ferreira, Germano, Stuurman, Anke L, Horsmans, Yves, Cattaert, Tom, Verstraeten, Thomas, Feng, Yang, Rosillon, Dominique, and Guignard, Adrienne

Abstract

OBJECTIVE: Assess the risk of progression to cirrhosis and hepatocellular carcinoma (HCC) due to hepatitis B virus (HBV)-infection in patients with nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (T2DM). METHODS: Retrospective cohort study in the UK Clinical Practice Research Datalink with three cohorts: subjects with T2DM and HBV infection (T2DM+HBV cohort; N = 297), with T2DM without HBV-infection (T2DM cohort; N = 261 865), and with HBV-infection without T2DM (HBV cohort; N = 3630). Primary analyses were performed on the three cohorts and secondary analyses on subcohorts including patients with NAFLD diagnosis code (N = 6599). Case/outcome definitions were formulated with International Classification of Diseases/Read codes/laboratory results and classified using validated algorithms. Adjusted incidence rate ratios (IRR) were estimated with a Poisson regression model. RESULTS: When comparing the T2DM+HBV and T2DM cohorts, adjusted IRRs were 14.06 (95% confidence interval: 4.47-44.19) for cirrhosis and 2.83 (1.06-7.55) for HCC. When comparing the T2DM+HBV and HBV cohorts, adjusted IRRs were 0.68 (0.21-2.27) for cirrhosis and 1.39 (0.46-4.20) for HCC. No cirrhosis cases were identified in T2DM+NAFLD+HBV patients; IRs were 16.92/10 000 person-years (12.97-21.69) and 85.24/10 000 person-years (10.32-307.91) in the T2DM+NAFLD and NAFLD+HBV cohorts. CONCLUSION: HBV-infection increased significantly the risk for cirrhosis among T2DM patients, however, not beyond the expected incremental risk among infected non-T2DM subjects. Our approach to evaluate the role of T2DM/NAFLD and HBV-infection in liver disease progression could be applied to other settings with higher HBV prevalence.

Published
2020

36. Efficacy and Safety of the CVnCoV SARS-CoV-2 mRNA Vaccine Candidate: Results from Herald, a Phase 2b/3, Randomised, Observer-Blinded, Placebo-Controlled Clinical Trial in Ten Countries in Europe and Latin America

Author

Kremsner, Peter G., primary, Guerrero, Rodolfo Andrés Ahuad, additional, Arana, Eunate, additional, Aroca Martinez, Gustavo Jose, additional, Bonten, Marc J.M., additional, Chandler, Reynaldo, additional, Corral, Gonzalo, additional, De Block, Eddie Jan Louis, additional, Ecker, Lucie, additional, Gabor, Julian Justin, additional, Garcia Lopez, Carlos Alberto, additional, Gonzales, Lucy, additional, Granados González, María Angélica, additional, Gorini, Nestor, additional, Grobusch, Martin P., additional, Hrabar, Adrian D., additional, Junker, Helga, additional, Kimura, Alan, additional, Lanata, Claudio F., additional, Lehmann, Clara, additional, Leroux-Roels, Isabel, additional, Mann, Philipp, additional, Martinez-Reséndez, Michel Fernando, additional, Ochoa, Theresa, additional, Poy, Carlos Alberto, additional, Reyes Fentanes, Maria Jose, additional, Mejia, Luis Maria Rivera, additional, Ruiz Herrera, Vida Veronica, additional, Sáez-Llorens, Xavier, additional, Schönborn-Kellenberger, Oliver, additional, Schunk, Mirjam, additional, Garcia, Alexandra Sierra, additional, Vergara, Itziar, additional, Verstraeten, Thomas, additional, Vico, Marisa, additional, Oostvogels, Lidia, additional, and Group, HERALD Study, additional

Published
2021
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37. Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases

Author

Verstraeten, Thomas, Davis, Robert L., DeStefano, Frank, Lieu, Tracy A., Rhodes, Philip H., Black, Steven B., Shinefield, Henry, and Chen, Robert T.

Abstract

Objective. To assess the possible toxicity of thimerosal-containing vaccines (TCVs) among infants. Methods. A 2-phased retrospective cohort study was conducted using computerized health maintenance organization (HMO) databases. Phase I screened for associations between neurodevelopmental disorders and thimerosal exposure among 124 170 infants who were born during 1992 to 1999 at 2 HMOs (A and B). In phase II, the most common disorders associated with exposure in phase I were reevaluated among 16 717 children who were born during 1991 to 1997 in another HMO (C). Relative risks for neurodevelopmental disorders were calculated per increase of 12.5 [micro]g of estimated cumulative mercury exposure from TCVs in the first, third, and seventh months of life. Results. In phase I at HMO A, cumulative exposure at 3 months resulted in a significant positive association with tics (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.05-3.38). At HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13; 95% CI: 1.01-1.27) and 7 months (RR: 1.07; 95% CI: 1.01-1.13). In phase II at HMO C, no significant associations were found. In no analyses were significant increased risks found for autism or attention-deficit disorder. Conclusions. No consistent significant associations were found between TCVs and neurodevelopmental outcomes. Conflicting results were found at different HMOs for certain outcomes. For resolving the conflicting findings, studies with uniform neurodevelopmental assessments of children with a range of cumulative thimerosal exposures are needed. Pediatrics 2003;112:1039-1048; cohort study, computerized medical record systems, language development disorders, speech disorders, thimerosal, vaccines., ABBREVIATIONS. Hg, mercury; EPA, Environmental Protection Agency; TCV, thimerosal-containing vaccine; HMO, health maintenance organization; VSD, Vaccine Safety Datalink; CDC, Centers for Disease Control and Prevention; LBW, low birth weight; ICD9-CM, [...]

Published
2003

41. Incorporating patient generated health data into pharmacoepidemiological research

Author

Bourke, Alison, primary, Dixon, William G., additional, Roddam, Andrew, additional, Lin, Kueiyu Joshua, additional, Hall, Gillian C., additional, Curtis, Jeffrey R., additional, van der Veer, Sabine N., additional, Soriano‐Gabarró, Montse, additional, Mills, Juliane K., additional, Major, Jacqueline M., additional, Verstraeten, Thomas, additional, Francis, Matthew J., additional, and Bartels, Dorothee B., additional

Published
2020
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42. Phase 1 Assessment of the Safety and Immunogenicity of an mRNA- Lipid Nanoparticle Vaccine Candidate Against SARS-CoV-2 in Human Volunteers

Author

Kremsner, Peter, primary, Mann, Philipp, additional, Bosch, Jacobus, additional, Fendel, Rolf, additional, Gabor, Julian J., additional, Kreidenweiss, Andrea, additional, Kroidl, Arne, additional, Leroux-Roels, Isabel, additional, Leroux-Roels, Geert, additional, Schindler, Christoph, additional, Schunk, Mirjam, additional, Velavan, Thirumalaisamy P., additional, Fotin-Mleczek, Mariola, additional, Müller, Stefan, additional, Quintini, Gianluca, additional, Schönborn-Kellenberger, Oliver, additional, Vahrenhorst, Dominik, additional, Verstraeten, Thomas, additional, Walz, Lisa, additional, Wolz, Olaf-Oliver, additional, and Oostvogels, Lidia, additional

Published
2020
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47. Diabetes mellitus as a vaccine-effect modifier: a review

Author

Verstraeten, Thomas, primary, Fletcher, Mark A., additional, Suaya, Jose A., additional, Jackson, Sally, additional, Hall-Murray, Cassandra K., additional, Scott, Daniel A., additional, Schmöle-Thoma, Beate, additional, Isturiz, Raul E., additional, and Gessner, Bradford D., additional

Published
2020
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