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28 results on '"Caso, Covadonga"'

1. Evaluación de la prueba fecal Liaison® Calprotectin de DiaSorin adaptada al derrame pleural

Author

de Paz Poves Cristina, Barneo-Caragol Clara, Cillero Sánchez Ana Isabel, Jiménez Mendiguchia Lucía, Quirós Caso Covadonga, Moreno Rodríguez María, López González Francisco J., and Prieto García Mª Belén

Subjects
automatización, calprotectina, quimioluminiscencia, líquido pleural, validación, Medical technology, R855-855.5
Abstract

La calprotectina (CP) es una proteína de unión a calcio y zinc que se suele determinar en muestras fecales, aunque su cuantificación en otros fluidos biológicos podría ser de interés. El objetivo del presente estudio es validar la determinación de CP en líquido pleural mediante quimioluminiscencia.

Published
2023
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2. Evaluation of DiaSorin Liaison® calprotectin fecal assay adapted for pleural effusion

Author

de Paz Poves Cristina, Barneo-Caragol Clara, Cillero Sánchez Ana Isabel, Jimenez Mendiguchia Lucía, Quirós Caso Covadonga, Moreno Rodríguez María, López González Francisco J., and Prieto García Mᵃ Belén

Subjects
automation, calprotectin, chemiluminescence, pleural fluid, validation, Medical technology, R855-855.5
Abstract

Calprotectin (CP) is a calcium and zinc binding protein that is widely measured on faecal samples but its determination in other biological fluids might be of interest. The aim of this work was to validate the measurement of CP in pleural fluid by chemiluminescence.

Published
2023
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3. Baseline immunophenotypic profile of bone marrow leukemia cells in acute myeloid leukemia with nucleophosmin-1 gene mutation: a EuroFlow study

Author

Matarraz, Sergio, Leoz, Pilar, Yeguas-Bermejo, Ana, van der Velden, Vincent, Bras, Anne E., Sánchez Gallego, Jose I., Lecrevisse, Quentin, Ayala-Bueno, Rosa, Teodosio, Cristina, Criado, Ignacio, González-González, María, Flores-Montero, Juan, Avendaño, Alejandro, Vidriales, María B., Chillón, María C., González, Teresa, García-Sanz, Ramón, Prieto Conde, María I., Villamor, Neus, Magnano, Laura, Colado, Enrique, Fernández, Paula, Sonneveld, Edwin, Philippé, Jan, Reiterová, Michaela, Caballero Berrocal, Juan C., Diaz-Gálvez, Francisco J., Ramos, Fernando, Dávila Valls, Julio, Manjón Sánchez, Raquel, Solano Tovar, Jackeline, Calvo, Xavier, García Alonso, Luis, Arenillas, Leonor, Alonso, Sara, Fonseca, Ariana, Quirós Caso, Covadonga, van Dongen, Jacques J. M., and Orfao, Alberto

Published
2023
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4. On Economic Applications of Information Theory

Author

Pérez, Rigoberto, López, Ana Jesús, Caso, Covadonga, Alvargonzález, Mercedes, Río, María Jesús, Kacprzyk, Janusz, Series Editor, Gil, Eduardo, editor, Gil, Eva, editor, Gil, Juan, editor, and Gil, María Ángeles, editor

Published
2018
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5. Barley-ß-glucans reduce systemic inflammation, renal injury and aortic calcification through ADAM17 and neutral-sphingomyelinase2 inhibition

Author

Arcidiacono, Maria Vittoria, Carrillo-López, Natalia, Panizo, Sara, Castro-Grattoni, Anabel L., Valcheva, Petya, Ulloa, Catalina, Rodríguez-Carrio, Javier, Cardús, Anna, Quirós-Caso, Covadonga, Martínez-Arias, Laura, Martínez-Salgado, Carlos, Motilva, María José, Rodriguez-Suarez, Carmen, Cannata-Andía, Jorge B., and Dusso, Adriana S.

Published
2019
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6. Baseline immunophenotypic profile of bone marrow leukemia cells in acute myeloid leukemia with nucleophosmin-1 gene mutation:a EuroFlow study

Author

Matarraz, Sergio, Leoz, Pilar, Yeguas-Bermejo, Ana, van der Velden, Vincent, Bras, Anne E., Sánchez Gallego, Jose I., Lecrevisse, Quentin, Ayala-Bueno, Rosa, Teodosio, Cristina, Criado, Ignacio, González-González, María, Flores-Montero, Juan, Avendaño, Alejandro, Vidriales, María B., Chillón, María C., González, Teresa, García-Sanz, Ramón, Prieto Conde, María I., Villamor, Neus, Magnano, Laura, Colado, Enrique, Fernández, Paula, Sonneveld, Edwin, Philippé, Jan, Reiterová, Michaela, Caballero Berrocal, Juan C., Diaz-Gálvez, Francisco J., Ramos, Fernando, Dávila Valls, Julio, Manjón Sánchez, Raquel, Solano Tovar, Jackeline, Calvo, Xavier, García Alonso, Luis, Arenillas, Leonor, Alonso, Sara, Fonseca, Ariana, Quirós Caso, Covadonga, van Dongen, Jacques J.M., Orfao, Alberto, Matarraz, Sergio, Leoz, Pilar, Yeguas-Bermejo, Ana, van der Velden, Vincent, Bras, Anne E., Sánchez Gallego, Jose I., Lecrevisse, Quentin, Ayala-Bueno, Rosa, Teodosio, Cristina, Criado, Ignacio, González-González, María, Flores-Montero, Juan, Avendaño, Alejandro, Vidriales, María B., Chillón, María C., González, Teresa, García-Sanz, Ramón, Prieto Conde, María I., Villamor, Neus, Magnano, Laura, Colado, Enrique, Fernández, Paula, Sonneveld, Edwin, Philippé, Jan, Reiterová, Michaela, Caballero Berrocal, Juan C., Diaz-Gálvez, Francisco J., Ramos, Fernando, Dávila Valls, Julio, Manjón Sánchez, Raquel, Solano Tovar, Jackeline, Calvo, Xavier, García Alonso, Luis, Arenillas, Leonor, Alonso, Sara, Fonseca, Ariana, Quirós Caso, Covadonga, van Dongen, Jacques J.M., and Orfao, Alberto

Published
2023

7. Prognostic Value of Measurable Residual Disease in Patients with AML Undergoing HSCT: A Multicenter Study

Author

Instituto de Salud Carlos III, Red de Terapia Celular (España), Redes de Investigación Cooperativa Orientadas a Resultados en Salud (España), Caballero-Velázquez, Teresa, Pérez-López, Olga, Yeguas Bermejo, Ana, Rodríguez-Arbolí, Eduardo, Colado, Enrique, Sempere, Amparo, Vidriales, Maria Belén, Solé Rodriguez, María, Quirós Caso, Covadonga, Pérez-López, Estefanía, Reinoso-Segura, Marta, Prats-Martín, Concepción, Montesinos, Pau, Pérez-Simón, José A., Instituto de Salud Carlos III, Red de Terapia Celular (España), Redes de Investigación Cooperativa Orientadas a Resultados en Salud (España), Caballero-Velázquez, Teresa, Pérez-López, Olga, Yeguas Bermejo, Ana, Rodríguez-Arbolí, Eduardo, Colado, Enrique, Sempere, Amparo, Vidriales, Maria Belén, Solé Rodriguez, María, Quirós Caso, Covadonga, Pérez-López, Estefanía, Reinoso-Segura, Marta, Prats-Martín, Concepción, Montesinos, Pau, and Pérez-Simón, José A.

Abstract

Allogeneic hematopoietic stem cell transplantation (HSCT) represents the best therapeutic option for many patients with acute myeloid leukemia (AML). However, relapse remains the main cause of mortality after transplantation. The detection of measurable residual disease (MRD) by multiparameter flow cytometry (MFC) in AML, before and after HSCT, has been described as a powerful predictor of outcome. Nevertheless, multicenter and standardized studies are lacking. A retrospective analysis was performed, including 295 AML patients undergoing HSCT in 4 centers that worked according to recommendations from the Euroflow consortium. Among patients in complete remission (CR), MRD levels prior to transplantation significantly influenced outcomes, with overall (OS) and leukemia free survival (LFS) at 2 years of 76.7% and 67.6% for MRD-negative patients, 68.5% and 49.7% for MRD-low patients (MRD < 0.1), and 50.5% and 36.6% for MRD-high patients (MRD ≥ 0.1) (p < 0.001), respectively. MRD level did influence the outcome, irrespective of the conditioning regimen. In our patient cohort, positive MRD on day +100 after transplantation was associated with an extremely poor prognosis, with a cumulative incidence of relapse of 93.3%. In conclusion, our multicenter study confirms the prognostic value of MRD performed in accordance with standardized recommendations.

Published
2023

8. Baseline immunophenotypic profile of bone marrow leukemia cells in acute myeloid leukemia with nucleophosmin-1 gene mutation: a EuroFlow study

Author

Instituto de Salud Carlos III, European Commission, Ministerio de Economía y Competitividad (España), Ministerio de Ciencia e Innovación (España), Ministry of Health of the Czech Republic, Matarraz, Sergio, Leoz, Pilar, Yeguas Bermejo, Ana, Velden, Vincent H. J. van der, Bras, A. E., Sánchez Gallego, Jose I., Lécrevisse, Quentin, Ayala Bueno, Rosa, Teodosio, Cristina, Criado, Ignacio, González-González, María, Flores-Montero, Juan, Avendaño, Alejandro, Vidriales, Maria Belén, Chillón, M. del Carmen, González, Teresa, García-Sanz, Ramón, Prieto Conde, María I., Villamor, Neus, Magnano, Laura, Colado, Enrique, Fernández, Paula, Sonneveld, Edwin, Philippé, J., Reiterová, Michaela, Caballero‐Berrocal, Juan C., Díaz Gálvez, Francisco Javier, Ramos, Fernando, Dávila, Julio, Manjón Sánchez, Raquel, Solano Tovar, Jackeline, Calvo, Xavier, García Alonso, Luis, Arenillas, Leonor, Alonso, Sara, Fonseca, Ariana, Quirós Caso, Covadonga, Dongen, J. J. M. van, Orfao, Alberto, Instituto de Salud Carlos III, European Commission, Ministerio de Economía y Competitividad (España), Ministerio de Ciencia e Innovación (España), Ministry of Health of the Czech Republic, Matarraz, Sergio, Leoz, Pilar, Yeguas Bermejo, Ana, Velden, Vincent H. J. van der, Bras, A. E., Sánchez Gallego, Jose I., Lécrevisse, Quentin, Ayala Bueno, Rosa, Teodosio, Cristina, Criado, Ignacio, González-González, María, Flores-Montero, Juan, Avendaño, Alejandro, Vidriales, Maria Belén, Chillón, M. del Carmen, González, Teresa, García-Sanz, Ramón, Prieto Conde, María I., Villamor, Neus, Magnano, Laura, Colado, Enrique, Fernández, Paula, Sonneveld, Edwin, Philippé, J., Reiterová, Michaela, Caballero‐Berrocal, Juan C., Díaz Gálvez, Francisco Javier, Ramos, Fernando, Dávila, Julio, Manjón Sánchez, Raquel, Solano Tovar, Jackeline, Calvo, Xavier, García Alonso, Luis, Arenillas, Leonor, Alonso, Sara, Fonseca, Ariana, Quirós Caso, Covadonga, Dongen, J. J. M. van, and Orfao, Alberto

Abstract

Molecular techniques are the gold standard method for the diagnosis of AML with mutated nucleophosmin gene (NPM1mut). However, their worldwide availability is limited and they provide limited insight into disease heterogeneity. Hence, surrogate markers of NPM1mut are used for fast diagnostic screening of the disease [1], including, among others, immunohistochemical detection of cytoplasmic NPM1 (NPM1c) [2], cup-like nuclear morphology [3], normal karyotype, and/or recurrent flow cytometry profiles -e.g., CD34 negativity, and/or a phenotype resembling acute promyelocytic leukemia (APL)- [4]. Nevertheless, some of these methods are also not widely available, they show limited sensitivity (e.g., low or absent NPM1c expression, particularly among monoblastic/monocytic AML-NPM1mut) [5], frequently lack standardized procedures [1], and they might also bring limited information about disease heterogeneity.

Published
2023

9. Evaluación de la prueba fecal Liaison® Calprotectin de DiaSorin adaptada al derrame pleural.

Author

de Paz Poves, Cristina, Barneo-Caragol, Clara, Cillero Sánchez, Ana Isabel, Jiménez Mendiguchia, Lucía, Quirós Caso, Covadonga, Moreno Rodríguez, María, López González, Francisco J., and Prieto García, Mª Belén

Abstract

Copyright of Advances in Laboratory Medicine / Avances en Medicina de Laboratorio is the property of De Gruyter and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2023
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10. Evaluation of DiaSorin Liaison® calprotectin fecal assay adapted for pleural effusion.

Author

de Paz Poves, Cristina, Barneo-Caragol, Clara, Cillero Sánchez, Ana Isabel, Jimenez Mendiguchia, Lucía, Quirós Caso, Covadonga, Moreno Rodríguez, María, López González, Francisco J., and Prieto García, Mᵃ Belén

Subjects
ZINC metabolism, FECAL analysis, PLEURAL effusions, PLEURA, AUTOANALYZERS, IMMUNOASSAY, QUALITY assurance, RESEARCH funding, DESCRIPTIVE statistics, AUTOMATION, CALCIUM-binding proteins, SENSITIVITY & specificity (Statistics), CARRIER proteins
Abstract

Calprotectin (CP) is a calcium and zinc binding protein that is widely measured on faecal samples but its determination in other biological fluids might be of interest. The aim of this work was to validate the measurement of CP in pleural fluid by chemiluminescence. LIAISON®XL, a fully automated chemiluminescence analyzer, was used for CP quantification on pleural fluid. A validation protocol was designed using both quality control materials provided by the manufacturer and pools of pleural fluid samples. Stability, imprecision, bias, linearity, detection capability and carry over effect were evaluated. CP was stable on pleural fluid at least one week, under refrigerated conditions, and four weeks at −80 °C. The observed intra- and inter-day imprecision was between 2.2 and 6.49 %, with a negative bias under 5.51 %. The linearity of the method was verified up to 2,000 ng/mL. The LoQ for the assay was 48.52 ng/mL. A statistically significant carry-over effect was observed after measuring CP concentrations above the upper limit of linearity, but given the observed magnitude, a clinically relevant impact should not be expected. DiaSorin Liaison® calprotectin assay allows reliable measurement of CP in pleural fluid. [ABSTRACT FROM AUTHOR]

Published
2023
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11. Prognostic Value of Measurable Residual Disease in Patients with AML Undergoing HSCT: A Multicenter Study

Author

Caballero-Velázquez, Teresa, primary, Pérez-López, Olga, additional, Yeguas Bermejo, Ana, additional, Rodríguez Arbolí, Eduardo, additional, Colado Varela, Enrique, additional, Sempere Talens, Amparo, additional, Vidriales, María Belén, additional, Solé-Rodríguez, María, additional, Quirós Caso, Covadonga, additional, Pérez López, Estefanía, additional, Reinoso Segura, Marta, additional, Prats-Martín, Concepción, additional, Montesinos, Pau, additional, and Pérez-Simón, Jose A., additional

Published
2023
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12. Routine flow cytometry approach for the evaluation of solid tumor neoplasms and immune cells in minimally invasive samples

Author

Quirós‐Caso, Covadonga, primary, Arias Fernández, Tamara, additional, Fonseca‐Mourelle, Ariana, additional, Torres, Héctor, additional, Fernández, Luis, additional, Moreno‐Rodríguez, Maria, additional, Ariza‐Prota, Miguel Ángel, additional, López‐González, Francisco Julián, additional, Carvajal‐Álvarez, Miguel, additional, Alonso‐Álvarez, Sara, additional, Moro‐García, Marco Antonio, additional, and Colado, Enrique, additional

Published
2022
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13. The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster : Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70

Author

Boutry, Céline, Hastie, Andrew, Diez-Domingo, Javier, Tinoco, Juan Carlos, Yu, Chong-Jen, Andrews, Charles, Beytout, Jean, Caso, Covadonga, Cheng, Huey-Shinn, Cheong, Hee Jin, Choo, Eun Ju, Curiac, Dan, Di Paolo, Emmanuel, Dionne, Marc, Eckermann, Tamara, Esen, Meral, Ferguson, Murdo, Ghesquiere, Wayne, Hwang, Shinn-Jang, Avelino-Silva, Thiago Junqueira, Kosina, Pavel, Liu, Chiu-Shong, Markkula, Jukka, Moeckesch, Beate, de Oliveira, Cláudia Murta, Park, Dae Won, Pauksens, Karlis, Pirrotta, Paola, Plassmann, Georg, Pretswell, Carol, Rombo, Lars, Salaun, Bruno, Sanmartin Berglund, Johan, Schenkenberger, Isabelle, Schwarz, Tino, Shi, Meng, Ukkonen, Benita, Zahaf, Toufik, Zerbini, Cristiano, Schuind, Anne, Cunningham, Anthony L, Boutry, Céline, Hastie, Andrew, Diez-Domingo, Javier, Tinoco, Juan Carlos, Yu, Chong-Jen, Andrews, Charles, Beytout, Jean, Caso, Covadonga, Cheng, Huey-Shinn, Cheong, Hee Jin, Choo, Eun Ju, Curiac, Dan, Di Paolo, Emmanuel, Dionne, Marc, Eckermann, Tamara, Esen, Meral, Ferguson, Murdo, Ghesquiere, Wayne, Hwang, Shinn-Jang, Avelino-Silva, Thiago Junqueira, Kosina, Pavel, Liu, Chiu-Shong, Markkula, Jukka, Moeckesch, Beate, de Oliveira, Cláudia Murta, Park, Dae Won, Pauksens, Karlis, Pirrotta, Paola, Plassmann, Georg, Pretswell, Carol, Rombo, Lars, Salaun, Bruno, Sanmartin Berglund, Johan, Schenkenberger, Isabelle, Schwarz, Tino, Shi, Meng, Ukkonen, Benita, Zahaf, Toufik, Zerbini, Cristiano, Schuind, Anne, and Cunningham, Anthony L

Abstract

Efficacy against herpes zoster and immune responses to the adjuvanted recombinant zoster vaccine plateaued at high levels between 5.1 and 7.1 years (mean) post-vaccination, suggesting that its clinical benefit in older adults is sustained for at least 7 years post-vaccination. Background This ongoing follow-up study evaluated the persistence of efficacy and immune responses for 6 additional years in adults vaccinated with the glycoprotein E (gE)-based adjuvanted recombinant zoster vaccine (RZV) at age >= 50 years in 2 pivotal efficacy trials (ZOE-50 and ZOE-70). The present interim analysis was performed after >= 2 additional years of follow-up (between 5.1 and 7.1 years [mean] post-vaccination) and includes partial data for year (Y) 8 post-vaccination. Methods Annual assessments were performed for efficacy against herpes zoster (HZ) from Y6 post-vaccination and for anti-gE antibody concentrations and gE-specific CD4[2+] T-cell (expressing >= 2 of 4 assessed activation markers) frequencies from Y5 post-vaccination. Results Of 7413 participants enrolled for the long-term efficacy assessment, 7277 (mean age at vaccination, 67.2 years), 813, and 108 were included in the cohorts evaluating efficacy, humoral immune responses, and cell-mediated immune responses, respectively. Efficacy of RZV against HZ through this interim analysis was 84.0% (95% confidence interval [CI], 75.9-89.8) from the start of this follow-up study and 90.9% (95% CI, 88.2-93.2) from vaccination in ZOE-50/70. Annual vaccine efficacy estimates were >84% for each year since vaccination and remained stable through this interim analysis. Anti-gE antibody geometric mean concentrations and median frequencies of gE-specific CD4[2+] T cells reached a plateau at approximately 6-fold above pre-vaccination levels. Conclusions Efficacy against HZ and immune responses to RZV remained high, suggesting that the clinical benefit of RZV in older adults is sustained for at least 7 years post-vaccination., Zoster-049 Study Groupopen access

Published
2022
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14. Prognosis Value of Measurable Residual Disease By Multiparameter Flow Cytotometry in Patients with Acute Myeloblastic Leukemia Prior to Allogeneic Hematopoietic Cell Transplantation

Author

Caballero, Teresa, primary, Pérez-López, Olga, additional, Yeguas Bermejo, Ana, additional, Rodriguez Arbolí, Eduardo, additional, Colado Varela, Enrique, additional, Sampere Talens, Maria Desamparados, additional, Belén Vidriales, María, additional, Quirós Caso, Covadonga, additional, Reinoso Segura, Marta, additional, Prats-Martín, Concepción, additional, Montesinos, Pau, additional, and Perez-Simon, Jose A., additional

Published
2021
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16. Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label study in previous ZOE-50 and ZOE-70 placebo recipients

Author

Dominicus Rolf, Ferrera Giuseppe, Freire Antônio Tarcísio, Lachance Pierre, Patrick Janice, Céline Boutry, Rodríguez de la Pinta Maria Luisa, Schaefer Axel, Hui David Shu Cheong, Schmidt Juergen, Plassmann Georg, Looze de Ferdinandus, Schenkenberger Isabelle, Josephine Ocran-Appiah, Toursarkissian Nicole, Grosskopf Josef, Beytout Jean, Staniscia Tommaso, Zahharova Irina, Klaff Leslie, Wachter Juergen, Kim Hyo Youl, Mueller Michael, Eto Takashi, Barbanti Piero, Lipetz Robert, Virta Miia, Ahonen Anitta, Ogata Hiroaki, Pauksens Karlis, McNally Damien, Grigat Christine, Geller Steven, Bengtsson Niklas, Poder Airi, Wilson Jonathan, Houser Patricia, Hwang Shinn-Jang, Berglund Johan Sanmartin, Jung Thomas, Rombo Lars, Datta Susan, Chlibeck Roman, Schubert Christian, Athan Eugene, Desole Maria Giuseppina, Huong Yieng, Dionne Marc, Stockhausen Juergen, Houle Pierre-Alain, Yunes Elsa Maria, Anne Schuind, Eckermann Tamara, Sueki Hirohiko, Schwarz Tino, Núñez López Concepción, Åke Olsson, Yeo Wilfred, Powell Calvin, Hartley Paul, Gerlach Beatrice, Curiac Dan, Hoeltz-Roehrig Susanne, Suzuki Shin, Mascareñas de Los Santos Abiel, Finneran Matthew, Ellison William, Narejos Pérez Silvia, Caroline Hervé, Pérez Vera Mercè, Powell Stephanie, Berndtsson Blom Katarina, Irimajiri Junya, Aldea Novo Marta, Dahmen Antje, Jacob Wilson, Kuroki Rie, Eizenberg Peter, Seppa Ilkka, Goldani Luciano, McNeil Shelly, Scott John, Liu Bo, Downey Herman Jackson, Andrews Charles, Caso Covadonga, Cunningham Anthony L, Toma Azhar, Lee Jacob, Ferguson Murdo, Weckx Lily, Berger-Roscher Juergen, Sauter Joachim, Park Dae Won, Forsten Aino, Barba-Gómez Jose-Fernando, Migliorino Guglielmo, Horacek Thomas, Levin Michael, Rosen Robert, Brotons Cuixart Carles, Koskinen Pekka, Schmitt Bernhard, Linnhoff Anneliese, Koenig Hans-Joachim, Tinoco Juan Carlos, Ghesquiere Wayne, Song Young Goo, Gauthier Jean-Sebastien, Icardi Giancarlo, Kokko Satu, Sha Edmund Kwok Yiu, Nakamura Kenjiro, Diez-Domingo Javier, Choo Eun-Ju, Lundvall Martin, Munir Abul Kashem, Jyoti Soni, Esen Meral, Arya Mark, Moeckesch Beate, Heaton Ken, Malempati Srikanth, Ervin John, Naritomi Yuji, Gorfinkel Iris, Manning Mary Beth, Tellier Guy, Poling Terry, and Lee Jin-Soo

Subjects
Vaccine safety, Adult, medicine.medical_specialty, Herpesvirus 3, Human, 030231 tropical medicine, Disease, Placebo, Herpes Zoster, 03 medical and health sciences, 0302 clinical medicine, Open label study, Adjuvants, Immunologic, Internal medicine, medicine, Herpes Zoster Vaccine, Humans, 030212 general & internal medicine, Adverse effect, Vaccines, Synthetic, General Veterinary, General Immunology and Microbiology, business.industry, Incidence (epidemiology), Public Health, Environmental and Occupational Health, Middle Aged, Vaccination, Infectious Diseases, Molecular Medicine, Zoster vaccine, business, medicine.drug
Abstract

Background Efficacy of the adjuvanted recombinant zoster vaccine (RZV) against herpes zoster (HZ) was demonstrated in pivotal trials ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). This study was designed to offer RZV to placebo recipients of these parent studies. Methods Vaccine safety and suspected HZ episode occurrence were assessed for 12 months following vaccination. Results Of the 14,550 eligible participants, 8687 received RZV and 97.8% completed the 2-dose schedule. During the 30-day post-vaccination period, 5175 (59.6%) participants experienced ≥ 1 unsolicited adverse event (AE), 4422 (50.9%) were vaccination-related. The most common AEs were injection-site reactions, pyrexia, and headache. During the study, 734 (8.4%) participants reported ≥ 1 serious AE (SAE) and 62 (0.7%) reported ≥ 1 potential immune-mediated disease (pIMD); 2 of each were assessed as vaccination-related. Suspected HZ episodes were reported by 30 participants (0.3%). Conclusions Nature and incidence of AEs, SAEs, and pIMDs were as expected and in line with the parent studies.

Published
2020

17. Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70.

Author

Boutry, Céline, Hastie, Andrew, Diez-Domingo, Javier, Tinoco, Juan Carlos, Yu, Chong-Jen, Andrews, Charles, Beytout, Jean, Caso, Covadonga, Cheng, Huey-Shinn, Cheong, Hee Jin, Choo, Eun Ju, Curiac, Dan, Paolo, Emmanuel Di, Dionne, Marc, Eckermann, Tamara, Esen, Meral, Ferguson, Murdo, Ghesquiere, Wayne, Hwang, Shinn-Jang, and Avelino-Silva, Thiago Junqueira

Subjects
BIOMARKERS, CONFIDENCE intervals, IMMUNOGLOBULINS, TIME, IMMUNOMODULATORS, VACCINE effectiveness, RANDOMIZED controlled trials, ANTIBODY formation, HERPES zoster vaccines, GLYCOPROTEINS, HERPES zoster, IMMUNITY, DESCRIPTIVE statistics, T cells, CELLULAR immunity, LONGITUDINAL method, EVALUATION, MIDDLE age, OLD age
Abstract

Background This ongoing follow-up study evaluated the persistence of efficacy and immune responses for 6 additional years in adults vaccinated with the glycoprotein E (gE)-based adjuvanted recombinant zoster vaccine (RZV) at age ≥50 years in 2 pivotal efficacy trials (ZOE-50 and ZOE-70). The present interim analysis was performed after ≥2 additional years of follow-up (between 5.1 and 7.1 years [mean] post-vaccination) and includes partial data for year (Y) 8 post-vaccination. Methods Annual assessments were performed for efficacy against herpes zoster (HZ) from Y6 post-vaccination and for anti-gE antibody concentrations and gE-specific CD4[2+] T-cell (expressing ≥2 of 4 assessed activation markers) frequencies from Y5 post-vaccination. Results Of 7413 participants enrolled for the long-term efficacy assessment, 7277 (mean age at vaccination, 67.2 years), 813, and 108 were included in the cohorts evaluating efficacy, humoral immune responses, and cell-mediated immune responses, respectively. Efficacy of RZV against HZ through this interim analysis was 84.0% (95% confidence interval [CI], 75.9–89.8) from the start of this follow-up study and 90.9% (95% CI, 88.2–93.2) from vaccination in ZOE-50/70. Annual vaccine efficacy estimates were >84% for each year since vaccination and remained stable through this interim analysis. Anti-gE antibody geometric mean concentrations and median frequencies of gE-specific CD4[2+] T cells reached a plateau at approximately 6-fold above pre-vaccination levels. Conclusions Efficacy against HZ and immune responses to RZV remained high, suggesting that the clinical benefit of RZV in older adults is sustained for at least 7 years post-vaccination. Clinical Trials Registration. NCT02723773. [ABSTRACT FROM AUTHOR]

Published
2022
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18. Altered Immunophenotypes on Leukemic and/or Monocytic Cells from Acute Myeloid Leukemia Highly Predict for Nucleophosmin Gene Mutation

Author

Matarraz, Sergio, primary, Leoz, Pilar, additional, Calvo, Xavier, additional, García Alonso, Luis, additional, Ayala Bueno, Rosa, additional, Sánchez-Gallego, José Ignacio, additional, Villamor, Neus, additional, Colado, Enrique, additional, Belén Vidriales, María, additional, Prieto Conde, María Isabel, additional, Chillon, Maria Carmen, additional, García-Sanz, Ramón, additional, Van Der Velden, Vincent H.J., additional, López Cadenas, Félix, additional, Díez-Campelo, María, additional, Arenillas, Leonor, additional, Alonso, Sara, additional, Fonseca, Ariana, additional, Quirós Caso, Covadonga, additional, Magnano, Laura, additional, Garcia Vela, José Antonio, additional, Fernandez, Carlos, additional, Damasceno, Daniela, additional, Mayado, Andrea, additional, Barrena, Susana, additional, and Orfao, Alberto, additional

Published
2019
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19. Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials

Author

Willer, David O., primary, Oostvogels, Lidia, additional, Cunningham, Anthony L., additional, Gervais, Pierre, additional, Gorfinkel, Iris, additional, Hyung Kim, Joon, additional, Talarico, Carla, additional, Wascotte, Valentine, additional, Zahaf, Toufik, additional, Colindres, Romulo, additional, Schuind, Anne, additional, Ahonen, Anitta, additional, Andrews, Charles, additional, Athan, Eugene, additional, Avelino-Silva, Thiago Junqueira, additional, Barba-Gomez, Jose-Fernando, additional, Berglund, Johan, additional, Cuixart, Carles Brotons, additional, Caso, Covadonga, additional, Chlibek, Roman, additional, Choi, Won Suk, additional, de Looze, Ferdinandus, additional, Desole, Maria Giuseppina, additional, Domingo, Javier Diez, additional, Downey, Jackson H., additional, Eizenberg, Peter, additional, Esen, Meral, additional, Ghesquiere, Wayne, additional, Hui, David Shu Cheong, additional, Hwang, Shinn-Jang, additional, Ikematsu, Hideyuki, additional, Johnson, Robert W., additional, Korhonen, Tiina, additional, Leung, Edward, additional, Levin, Myron, additional, de Los Santos, Abiel Mascarenas, additional, McElhaney, Janet, additional, McNeil, Shelly, additional, Narejos Perez, Silvia, additional, Pauksens, Karlis, additional, Pellegrino, Angelo, additional, Poder, Airi, additional, Barbera, Joan Puig, additional, dos Santos, Rodrigo Ribeiro, additional, de la Pinta, Maria Luisa Rodriguez, additional, Rombo, Lars, additional, Schwarz, Tino F., additional, Seppa, Ilkka, additional, Smetana, Jan, additional, Staniscia, Tommaso, additional, Thompson, Alexander, additional, Tinoco, Juan Carlos, additional, Toma, Azhar, additional, Watanabe, Daisuke, additional, Weckx, Lily, additional, and Wilfred, Yeo, additional

Published
2019
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20. Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Author

López-Fauqued, Marta, primary, Campora, Laura, additional, Delannois, Frédérique, additional, El Idrissi, Mohamed, additional, Oostvogels, Lidia, additional, De Looze, Ferdinandus J., additional, Diez-Domingo, Javier, additional, Heineman, Thomas C., additional, Lal, Himal, additional, McElhaney, Janet E., additional, McNeil, Shelly A., additional, Yeo, Wilfred, additional, Tavares-Da-Silva, Fernanda, additional, Ahonen, Anitta, additional, Avelino-Silva, Thiago Junquera, additional, Barba-Gomez, Jose Fernando, additional, Berglund, Johan, additional, Cuixart, Carlos Brotons, additional, Caso, Covadonga, additional, Chlibek, Roman, additional, Choi, Won Suk, additional, Cunningham, Anthony L., additional, Desole, Maria Guiseppina, additional, Eizenberg, Peter, additional, Esen, Meral, additional, Espié, Emmanuelle, additional, Gervais, Pierre, additional, Ghesquiere, Wayne, additional, Godeaux, Olivier, additional, Gorfinkel, Iris, additional, Hui, David Shu Cheong, additional, Hwang, Shinn-Jang, additional, Korhonen, Tiina, additional, Kovac, Martina, additional, Ledent, Edouard, additional, Leung, Edward, additional, Levin, Myron J., additional, Perez, Silvia Narejos, additional, Neto, Jose Luiz, additional, Pauksens, Karlis, additional, Poder, Airi, additional, de la Pinta, Maria Luisa Rodriguez, additional, Rombo, Lars, additional, Schwarz, Tino F., additional, Smetana, Jan, additional, Staniscia, Tommaso, additional, Tinoco, Juan Carlos, additional, Toma, Azhar, additional, Vastiau, Ilse, additional, Vesikari, Timo, additional, Volpi, Antonio, additional, Watanabe, Daisuke, additional, Weckx, Lily Yin, additional, and Zahaf, Toufik, additional

Published
2019
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21. Safety profile of the adjuvanted recombinant zoster vaccine : Pooled analysis of two large randomised phase 3 trials

Author

Lopez-Fauqued, Marta, Campora, Laura, Delannois, Frederique, El Idrissi, Mohamed, Oostvogels, Lidia, De Looze, Ferdinandus J., Diez-Domingo, Javier, Heineman, Thomas C., Lal, Himal, McElhaney, Janet E., McNeil, Shelly A., Yeo, Wilfred, Tavares-Da-Silva, Fernanda, Ahonen, Anitta, Avelino-Silva, Thiago Junquera, Fernando Barba-Gomez, Jose, Berglund, Johan, Brotons Cuixart, Carlos, Caso, Covadonga, Chlibek, Roman, Choi, Won Suk, Cunningham, Anthony L., Desole, Maria Guiseppina, Eizenberg, Peter, Esen, Meral, Espie, Emmanuelle, Gervais, Pierre, Ghesquiere, Wayne, Godeaux, Olivier, Gorfinkel, Iris, Hui, David Shu Cheong, Hwang, Shinn-Jang, Korhonen, Tiina, Kovac, Martina, Ledent, Edouard, Leung, Edward, Levin, Myron J., Narejos Perez, Silvia, Neto, Jose Luiz, Pauksen, Karlis, Poder, Airi, Rodriguez de la Pinta, Maria Luisa, Rombo, Lars, Schwarz, Tino F., Smetana, Jan, Staniscia, Tommaso, Tinoco, Juan Carlos, Toma, Azhar, Vastiau, Ilse, Vesikari, Timo, Volpi, Antonio, Watanabe, Daisuke, Weckx, Lily Yin, Zahaf, Toufik, Lopez-Fauqued, Marta, Campora, Laura, Delannois, Frederique, El Idrissi, Mohamed, Oostvogels, Lidia, De Looze, Ferdinandus J., Diez-Domingo, Javier, Heineman, Thomas C., Lal, Himal, McElhaney, Janet E., McNeil, Shelly A., Yeo, Wilfred, Tavares-Da-Silva, Fernanda, Ahonen, Anitta, Avelino-Silva, Thiago Junquera, Fernando Barba-Gomez, Jose, Berglund, Johan, Brotons Cuixart, Carlos, Caso, Covadonga, Chlibek, Roman, Choi, Won Suk, Cunningham, Anthony L., Desole, Maria Guiseppina, Eizenberg, Peter, Esen, Meral, Espie, Emmanuelle, Gervais, Pierre, Ghesquiere, Wayne, Godeaux, Olivier, Gorfinkel, Iris, Hui, David Shu Cheong, Hwang, Shinn-Jang, Korhonen, Tiina, Kovac, Martina, Ledent, Edouard, Leung, Edward, Levin, Myron J., Narejos Perez, Silvia, Neto, Jose Luiz, Pauksen, Karlis, Poder, Airi, Rodriguez de la Pinta, Maria Luisa, Rombo, Lars, Schwarz, Tino F., Smetana, Jan, Staniscia, Tommaso, Tinoco, Juan Carlos, Toma, Azhar, Vastiau, Ilse, Vesikari, Timo, Volpi, Antonio, Watanabe, Daisuke, Weckx, Lily Yin, and Zahaf, Toufik

Abstract

Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was >= 90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged >= 50 (ZOE-50) and >= 70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV.

Published
2019
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23. Arquitectura efímera y metodología proyectual en los pabellones de la Serpentine Gallery de Londres

Author

Celigueta Caso, Covadonga and Serrano Bergera, José Ignacio

Abstract

La inquietud por explorar a fondo aquellas manifestaciones arquitectónicas no estudiadas específicamente a lo largo de la carrera sirvió como motivación para realizar un estudio analítico de la arquitectura efímera. El interés por conocer las motivaciones y destrezas de aquellos arquitectos que las proyectan bajo unas condiciones de tiempo y economía estrictas me llevó a escoger los pabellones de la Serpentine Gallery como objeto de análisis. A pesar de que mucha gente relaciona los pabellones efímeros con los ensayos formales y el diseño más que con la arquitectura, este trabajo demuestra como arquitectos de renombre internacional presentan una profunda inquietud y aprovechan esta oportunidad para experimentar con las soluciones contemporáneas constructivas y cómo, gracias a la libertad creativa, logran incorporar propuestas innovadoras tanto en el ámbito constructivo como espacial, logrando en bastantes casos una conexión sensorial y personal casi inmediata con los usuarios de los proyectos.

Published
2017

25. Superior antigen-specific CD4+T-cell response with AS03-adjuvantation of a trivalent influenza vaccine in a randomised trial of adults aged 65 and older

Author

Couch, Robert B, primary, Bayas, José M, additional, Caso, Covadonga, additional, Mbawuike, Innocent Nnadi, additional, López, Concepción Núñez, additional, Claeys, Carine, additional, El Idrissi, Mohamed, additional, Hervé, Caroline, additional, Laupèze, Béatrice, additional, Oostvogels, Lidia, additional, and Moris, Philippe, additional

Published
2014
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26. Superior antigen-specific CD4+ T-cell response with AS03-adjuvantation of a trivalent influenza vaccine in a randomised trial of adults aged 65 and older.

Author

Couch, Robert B., Bayas, José M., Caso, Covadonga, Mbawuike, Innocent Nnadi, Núñez López, Concepción, Claeys, Carine, El Idrissi, Mohamed, Hervé, Caroline, Laupèze, Béatrice, Oostvogels, Lidia, and Moris, Philippe

Abstract

Background: The effectiveness of trivalent influenza vaccines may be reduced in older versus younger adults because of age-related immunosenescence. The use of an adjuvant in such a vaccine is one strategy that may combat immunosenescence, potentially by bolstering T-cell mediated responses. Methods: This observer-blind study, conducted in the United States (US) and Spain during the 2008–2009 influenza season, evaluated the effect of Adjuvant System AS03 on specific T-cell responses to a seasonal trivalent influenza vaccine (TIV) in ≥65 year-old adults. Medically-stable adults aged ≥65 years were randomly allocated to receive a single dose of AS03-adjuvanted TIV (TIV/AS03) or TIV. Healthy adults aged 18–40 years received only TIV. Blood samples were collected on Day 0, Day 21, Day 42 and Day 180. Influenza-specific CD4+ T cells, defined by the induction of the immune markers CD40L, IL-2, IFN-γ, or TNF-α, were measured in ex vivo cultures of antigen-stimulated peripheral blood mononuclear cells. Results: A total of 192 adults were vaccinated: sixty nine and seventy three ≥65 year olds received TIV/AS03 and TIV, respectively; and fifty 18 − 40 year olds received TIV. In the ≥65 year-old group on Day 21, the frequency of CD4+ T cells specific to the three vaccine strains was superior in the TIV/AS03 recipients to the frequency in TIV (p < 0.001). On Days 42 and 180, the adjusted-geometric mean specific CD4+ T-cell frequencies were also higher in the TIV/AS03 recipients than in the TIV recipients (p < 0.001). Furthermore, the adjusted-geometric mean specific CD4+ T-cell frequencies were higher in the ≥65 year-old recipients of TIV/AS03 than in the 18 − 40 year old recipients of TIV on Days 21 (p = 0.006) and 42 (p = 0.011). Conclusion: This positive effect of AS03 Adjuvant System on the CD4+ T-cell response to influenza vaccine strains in older adults could confer benefit in protection against clinical influenza disease in this population. [ABSTRACT FROM AUTHOR]

Published
2014
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