دورية أكاديمية
Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial
العنوان: | Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial |
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المؤلفون: | Mullane K. M., Morrison V. A., Camacho L. H., Arvin A., McNeil S. A., Durrand J., Campbell B., Su S. -C., Chan I. S. F., Parrino J., Kaplan S. S., Popmihajlov Z., Annunziato P. W., Cerana S., Dictar M. O., Bonvehi P., Tregnaghi J. P., Fein L., Ashley D., Singh M., Hayes T., Playford G., Morrissey O., Thaler J., Kuehr T., Greil R., Pecherstorfer M., Duck L., Van Eygen K., Aoun M., De Prijck B., Franke F. A., Barrios C. H. E., Mendes A. V. A., Serrano S. V., Garcia R. F., Moore F., Camargo J. F. C., Pires L. A., Alves R. S., Radinov A., Oreshkov K., Minchev V., Hubenova A. I., Koynova T., Ivanov I., Rabotilova B., Petrov P. A., Chilingirov P., Karanikolov S., Raynov J., Grimard D., McNeil S., Kumar D., Larratt L. M., Weiss K., Delage R., Diaz-Mitoma F. J., Cano P. O., Couture F., Carvajal P., Yepes A., Torres Ulloa R., Fardella P., Caglevic C., Rojas C., Orellana E., Gonzalez P., Acevedo A., Galvez K. M., Gonzalez M. E., Franco S., Restrepo J. G., Rojas C. A., Bonilla C., Florez L. E., Ospina A. V., Manneh R., Zorica R., Vrdoljak D. V., Samarzija M., Petruzelka L., Vydra J., Mayer J., Cibula D., Prausova J., Paulson G., Ontaneda M., Palk K., Vahlberg A., Rooneem R., Galtier F., Postil D., Lucht F., Laine F., Launay O., Laurichesse H., Duval X., Cornely O. A., Camerer B., Panse J., Zaiss M., Derigs H. -G., Menzel H., Verbeek M., Georgoulias V., Mavroudis D., Anagnostopoulos A., Terpos E., Cortes D., Umanzor J., Bejarano S., Galeano R. W., Wong R. S. M., Hui P., Pedrazzoli P., Ruggeri L., Aversa F., Bosi A., Gentile G., Rambaldi A., Contu A., Marei L., Abbadi A., Hayajneh W., Kattan J., Farhat F., Chahine G., Rutkauskiene J., Marfil Rivera L. J., Lopez Chuken Y. A., Franco Villarreal H., Lopez Hernandez J., Blacklock H., Lopez R. I., Alvarez R., Gomez A. M., Quintana T. S., Moreno Larrea M. D. C., Zorrilla S. J., Alarcon E., Samanez F. C. A., Caguioa P. B., Tiangco B. J., Mora E. M., Betancourt-Garcia R. D., Hallman-Navarro D., Feliciano-Lopez L. J., Velez-Cortes H. A., Cabanillas F., Ganea D. E., Ciuleanu T. E., Ghizdavescu D. G., Miron L., Cebotaru C. L., Cainap C. I., Anghel R., Dvorkin M. V., Gladkov O. A., Fadeeva N. V., Kuzmin A. A., Lipatov O. N., Zbarskaya I. I., Akhmetzyanov F. S., Litvinov I. V., Afanasyev B. V., Cherenkova M., Lioznov D., Lisukov I. A., Smirnova Y. A., Kolomietz S., Halawani H., Goh Y. T., Drgona L., Chudej J., Matejkova M., Reckova M., Rapoport B. L., Szpak W. M., Malan D. R., Jonas N., Jung C. W., Lee D. G., Yoon S. S., Lopez Jimenez J., Duran Martinez I., Rodriguez Moreno J. F., Solano Vercet C., de la Camara R., Batlle Massana M., Yeh S. -P., Chen C. -Y., Chou H. -H., Tsai C. -M., Chiu C. -H., Siritanaratkul N., Norasetthada L., Sriuranpong V., Seetalarom K., Akan H., Dane F., Ozcan M. A., Ozsan G. H., Kalayoglu Besisik S. F., Cagatay A., Yalcin S., Peniket A., Mullan S. R., Dakhil K. M., Sivarajan K., Suh J. J. -G., Sehgal A., Marquez F., Gomez E. G., Mullane M. R., Skinner W. L., Behrens R. J., Trevarthe D. R., Mazurczak M. A., Lambiase E. A., Vidal C. A., Anac S. Y., Rodrigues G. A., Baltz B., Boccia R., Wertheim M. S., Holladay C. S., Zenk D., Fusselman W., Wade III J. L., Jaslowsk A. J., Keegan J., Robinson M. O., Go R. S., Farnen J., Amin B., Jurgens D., Risi G. F., Beatty P. G., Naqvi T., Parshad S., Hansen V. L., Ahmed M., Steen P. D., Badarinath S., Dekker A., Scouros M. A., Young D. E., Graydon Harker W., Kendall S. D., Citron M. L., Chedid S., Posada J. G., Gupta M. K., Rafiyath S., Buechler-Price J., Sreenivasappa S., Chay C. H., Burke J. M., Young S. E., Mahmood A., Kugler J. W., Gerstner G., Fuloria J., Belman N. D., Geller R., Nieva J., Whittenberger B. P., Wong B. M. Y., Cescon T. P., Abesada-Terk G., Guarino M. J., Zweibach A., Ibrahim E. N., Takahashi G., Garrison M. A., Mowat R. B., Choi B. S., Oliff I. A., Singh J., Guter K. A., Ayrons K., Rowland K. M., Noga S. J., Rao S. B., Columbie A., Nualart M. T., Cecchi G. R., Campos L. T., Mohebtash M., Flores M. R., Rothstein-Rubin R., O'Connor B. M., Soori G., Knapp M., Miranda F. G., Goodgame B. W., Kassem M., Belani R., Sharma S., Ortiz T., Sonneborn H. L., Markowitz A. B., Wilbur D., Meiri E., Koo V. S., Jhangiani H. S., Wong L., Sanani S., Lawrence S. J., Jones C. M., Murray C., Papageorgiou C., Gurtler J. S., Ascensao J. L., Venigalla M. L., D'Andrea M., De Las Casas C., Haile D. J., Qazi F. U., Santander J. L., Thomas M. R., Rao V. P., Craig M., Garg R. J., Robles R., Lyons R. M., Stegemoller R. K., Goel S., Garg S., Lowry P., Lynch C., Lash B., Repka T., Baker J., Goueli B. S., Campbell T. C., Van Echo D. A., Lee Y. J., Reyes E. A., Senecal F. M., Donnelly G., Byeff P., Weiss R., Reid T., Roeland E., Goel A., Prow D. M., Brandt D. S., Kaplan H. G., Payne J. E., Boeckh M. G., Rosen P. J., Mena R. R., Khan R., Betts R. F., Sharp S. A., Fitz-Patrick D., Congdon J., Erickson N., Abbasi R., Henderson S., Mehdi A., Wos E. J., Rehmus E., Beltzer L., Tamayo R. A., Mahmood T., Reboli A. C., Moore A., Brown J. M., Cruz J., Quick D. P., Potz J. L., Kotz K. W., Hutchins M., Chowhan N. M., Devabhaktuni Y. D., Braly P., Berenguer R. A., Shambaugh S. C., O'Rourke T. J., Conkright W. A., Winkler C. F., Addo F. E. K., Duic J. P., High K. P., Kutner M. E., Collins R., Carrizosa D. R., Perry D. J., Kailath E., Rosen N., Sotolongo R., Shoham S., Chen T. |
المساهمون: | Mullane, K. M., Morrison, V. A., Camacho, L. H., Arvin, A., Mcneil, S. A., Durrand, J., Campbell, B., Su, S. -C., Chan, I. S. F., Parrino, J., Kaplan, S. S., Popmihajlov, Z., Annunziato, P. W., Cerana, S., Dictar, M. O., Bonvehi, P., Tregnaghi, J. P., Fein, L., Ashley, D., Singh, M., Hayes, T., Playford, G., Morrissey, O., Thaler, J., Kuehr, T., Greil, R., Pecherstorfer, M., Duck, L., Van Eygen, K., Aoun, M., De Prijck, B., Franke, F. A., Barrios, C. H. E., Mendes, A. V. A., Serrano, S. V., Garcia, R. F., Moore, F., Camargo, J. F. C., Pires, L. A., Alves, R. S., Radinov, A., Oreshkov, K., Minchev, V., Hubenova, A. I., Koynova, T., Ivanov, I., Rabotilova, B., Petrov, P. A., Chilingirov, P., Karanikolov, S., Raynov, J., Grimard, D., Mcneil, S., Kumar, D., Larratt, L. M., Weiss, K., Delage, R., Diaz-Mitoma, F. J., Cano, P. O., Couture, F., Carvajal, P., Yepes, A., Torres Ulloa, R., Fardella, P., Caglevic, C., Rojas, C., Orellana, E., Gonzalez, P., Acevedo, A., Galvez, K. M., Gonzalez, M. E., Franco, S., Restrepo, J. G., Rojas, C. A., Bonilla, C., Florez, L. E., Ospina, A. V., Manneh, R., Zorica, R., Vrdoljak, D. V., Samarzija, M., Petruzelka, L., Vydra, J., Mayer, J., Cibula, D., Prausova, J., Paulson, G., Ontaneda, M., Palk, K., Vahlberg, A., Rooneem, R., Galtier, F., Postil, D., Lucht, F., Laine, F., Launay, O., Laurichesse, H., Duval, X., Cornely, O. A., Camerer, B. |
بيانات النشر: | Lancet Publishing Group THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND |
سنة النشر: | 2019 |
المجموعة: | Sapienza Università di Roma: CINECA IRIS |
مصطلحات موضوعية: | vaccine, varicella-zoster, herpes-zoster, immunocompromised, haematological malignancies |
الوصف: | Background Patients who are immunocompromised because of malignancy have an increased risk of herpes zoster and herpes zoster-related complications. We aimed to investigate the efficacy and safety of an inactivated varicella zoster virus (VZV) vaccine for herpes zoster prevention in patients with solid tumour or haematological malignancies.Methods This phase 3, two-ann, randomised, double-blind, placebo-controlled, inulticentre trial with an adaptive design was done in 329 centres across 40 countries. The trial included adult patients with solid tumour malignancies receiving chemotherapy and those with haematological malignancies, either receiving or not receiving chemotherapy. Patients were randomly assigned (1:1) to receive four doses of VZV vaccine inactivated by v irradiation or placebo approximately 30 days apart. The patients, investigators, trial site staff, clinical adjudication committee, and sponsor's clinical and laboratory personnel were masked to the group assignment. The primary efficacy endpoint was herpes zoster incidence in patients with solid tumour malignancies receiving chemotherapy, which was assessed in the modified intention-to-treat population (defined as all randomly assigned patients who received at least one dose of inactivated VZV vaccine or placebo). The primary safety endpoint was serious adverse events up to 28 days after the fourth dose in patients with solid tumour malignancies receiving chemotherapy. Safety endpoints were assessed in all patients who received at least one dose of inactivated VZV vaccine or placebo and had follow-up data. This trial is registered (NCT01254630 and EudraCT 2010-023156-89).Findings Between June 27, 2011, and April 11,2017,5286 patients were randomly assigned to receive VZV vaccine inactivated by gamma irradiation (n=2637) or placebo (n=2649). The haematological malignancy arm was terminated early because of evidence of futility at a planned interim analysis; therefore, all prespecified haematological malignancy endpoints were deemed exploratory. In ... |
نوع الوثيقة: | article in journal/newspaper |
اللغة: | English |
العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/:31399378; info:eu-repo/semantics/altIdentifier/wos/WOS:000484017800032; volume:19; issue:9; firstpage:1001; lastpage:1012; numberofpages:12; journal:THE LANCET INFECTIOUS DISEASES; http://hdl.handle.net/11573/1331005Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85071372218 |
DOI: | 10.1016/S1473-3099(19)30310-X |
الإتاحة: | https://doi.org/10.1016/S1473-3099Test(19)30310-X http://hdl.handle.net/11573/1331005Test |
حقوق: | info:eu-repo/semantics/closedAccess |
رقم الانضمام: | edsbas.CB6E58B4 |
قاعدة البيانات: | BASE |
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edsbas BASE edsbas.CB6E58B4 834 3 Academic Journal academicJournal 833.687927246094 |
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M.</searchLink><br /><searchLink fieldCode="AR" term="%22Hui+P%2E%22">Hui P.</searchLink><br /><searchLink fieldCode="AR" term="%22Pedrazzoli+P%2E%22">Pedrazzoli P.</searchLink><br /><searchLink fieldCode="AR" term="%22Ruggeri+L%2E%22">Ruggeri L.</searchLink><br /><searchLink fieldCode="AR" term="%22Aversa+F%2E%22">Aversa F.</searchLink><br /><searchLink fieldCode="AR" term="%22Bosi+A%2E%22">Bosi A.</searchLink><br /><searchLink fieldCode="AR" term="%22Gentile+G%2E%22">Gentile G.</searchLink><br /><searchLink fieldCode="AR" term="%22Rambaldi+A%2E%22">Rambaldi A.</searchLink><br /><searchLink fieldCode="AR" term="%22Contu+A%2E%22">Contu A.</searchLink><br /><searchLink fieldCode="AR" term="%22Marei+L%2E%22">Marei L.</searchLink><br /><searchLink fieldCode="AR" term="%22Abbadi+A%2E%22">Abbadi A.</searchLink><br /><searchLink fieldCode="AR" term="%22Hayajneh+W%2E%22">Hayajneh W.</searchLink><br /><searchLink fieldCode="AR" term="%22Kattan+J%2E%22">Kattan J.</searchLink><br /><searchLink fieldCode="AR" term="%22Farhat+F%2E%22">Farhat F.</searchLink><br /><searchLink fieldCode="AR" term="%22Chahine+G%2E%22">Chahine G.</searchLink><br /><searchLink fieldCode="AR" term="%22Rutkauskiene+J%2E%22">Rutkauskiene J.</searchLink><br /><searchLink fieldCode="AR" term="%22Marfil+Rivera+L%2E+J%2E%22">Marfil Rivera L. J.</searchLink><br /><searchLink fieldCode="AR" term="%22Lopez+Chuken+Y%2E+A%2E%22">Lopez Chuken Y. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Franco+Villarreal+H%2E%22">Franco Villarreal H.</searchLink><br /><searchLink fieldCode="AR" term="%22Lopez+Hernandez+J%2E%22">Lopez Hernandez J.</searchLink><br /><searchLink fieldCode="AR" term="%22Blacklock+H%2E%22">Blacklock H.</searchLink><br /><searchLink fieldCode="AR" term="%22Lopez+R%2E+I%2E%22">Lopez R. I.</searchLink><br /><searchLink fieldCode="AR" term="%22Alvarez+R%2E%22">Alvarez R.</searchLink><br /><searchLink fieldCode="AR" term="%22Gomez+A%2E+M%2E%22">Gomez A. M.</searchLink><br /><searchLink fieldCode="AR" term="%22Quintana+T%2E+S%2E%22">Quintana T. S.</searchLink><br /><searchLink fieldCode="AR" term="%22Moreno+Larrea+M%2E+D%2E+C%2E%22">Moreno Larrea M. D. C.</searchLink><br /><searchLink fieldCode="AR" term="%22Zorrilla+S%2E+J%2E%22">Zorrilla S. J.</searchLink><br /><searchLink fieldCode="AR" term="%22Alarcon+E%2E%22">Alarcon E.</searchLink><br /><searchLink fieldCode="AR" term="%22Samanez+F%2E+C%2E+A%2E%22">Samanez F. C. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Caguioa+P%2E+B%2E%22">Caguioa P. B.</searchLink><br /><searchLink fieldCode="AR" term="%22Tiangco+B%2E+J%2E%22">Tiangco B. J.</searchLink><br /><searchLink fieldCode="AR" term="%22Mora+E%2E+M%2E%22">Mora E. M.</searchLink><br /><searchLink fieldCode="AR" term="%22Betancourt-Garcia+R%2E+D%2E%22">Betancourt-Garcia R. D.</searchLink><br /><searchLink fieldCode="AR" term="%22Hallman-Navarro+D%2E%22">Hallman-Navarro D.</searchLink><br /><searchLink fieldCode="AR" term="%22Feliciano-Lopez+L%2E+J%2E%22">Feliciano-Lopez L. J.</searchLink><br /><searchLink fieldCode="AR" term="%22Velez-Cortes+H%2E+A%2E%22">Velez-Cortes H. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Cabanillas+F%2E%22">Cabanillas F.</searchLink><br /><searchLink fieldCode="AR" term="%22Ganea+D%2E+E%2E%22">Ganea D. E.</searchLink><br /><searchLink fieldCode="AR" term="%22Ciuleanu+T%2E+E%2E%22">Ciuleanu T. E.</searchLink><br /><searchLink fieldCode="AR" term="%22Ghizdavescu+D%2E+G%2E%22">Ghizdavescu D. G.</searchLink><br /><searchLink fieldCode="AR" term="%22Miron+L%2E%22">Miron L.</searchLink><br /><searchLink fieldCode="AR" term="%22Cebotaru+C%2E+L%2E%22">Cebotaru C. L.</searchLink><br /><searchLink fieldCode="AR" term="%22Cainap+C%2E+I%2E%22">Cainap C. I.</searchLink><br /><searchLink fieldCode="AR" term="%22Anghel+R%2E%22">Anghel R.</searchLink><br /><searchLink fieldCode="AR" term="%22Dvorkin+M%2E+V%2E%22">Dvorkin M. V.</searchLink><br /><searchLink fieldCode="AR" term="%22Gladkov+O%2E+A%2E%22">Gladkov O. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Fadeeva+N%2E+V%2E%22">Fadeeva N. V.</searchLink><br /><searchLink fieldCode="AR" term="%22Kuzmin+A%2E+A%2E%22">Kuzmin A. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Lipatov+O%2E+N%2E%22">Lipatov O. N.</searchLink><br /><searchLink fieldCode="AR" term="%22Zbarskaya+I%2E+I%2E%22">Zbarskaya I. I.</searchLink><br /><searchLink fieldCode="AR" term="%22Akhmetzyanov+F%2E+S%2E%22">Akhmetzyanov F. S.</searchLink><br /><searchLink fieldCode="AR" term="%22Litvinov+I%2E+V%2E%22">Litvinov I. V.</searchLink><br /><searchLink fieldCode="AR" term="%22Afanasyev+B%2E+V%2E%22">Afanasyev B. V.</searchLink><br /><searchLink fieldCode="AR" term="%22Cherenkova+M%2E%22">Cherenkova M.</searchLink><br /><searchLink fieldCode="AR" term="%22Lioznov+D%2E%22">Lioznov D.</searchLink><br /><searchLink fieldCode="AR" term="%22Lisukov+I%2E+A%2E%22">Lisukov I. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Smirnova+Y%2E+A%2E%22">Smirnova Y. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Kolomietz+S%2E%22">Kolomietz S.</searchLink><br /><searchLink fieldCode="AR" term="%22Halawani+H%2E%22">Halawani H.</searchLink><br /><searchLink fieldCode="AR" term="%22Goh+Y%2E+T%2E%22">Goh Y. T.</searchLink><br /><searchLink fieldCode="AR" term="%22Drgona+L%2E%22">Drgona L.</searchLink><br /><searchLink fieldCode="AR" term="%22Chudej+J%2E%22">Chudej J.</searchLink><br /><searchLink fieldCode="AR" term="%22Matejkova+M%2E%22">Matejkova M.</searchLink><br /><searchLink fieldCode="AR" term="%22Reckova+M%2E%22">Reckova M.</searchLink><br /><searchLink fieldCode="AR" term="%22Rapoport+B%2E+L%2E%22">Rapoport B. L.</searchLink><br /><searchLink fieldCode="AR" term="%22Szpak+W%2E+M%2E%22">Szpak W. M.</searchLink><br /><searchLink fieldCode="AR" term="%22Malan+D%2E+R%2E%22">Malan D. R.</searchLink><br /><searchLink fieldCode="AR" term="%22Jonas+N%2E%22">Jonas N.</searchLink><br /><searchLink fieldCode="AR" term="%22Jung+C%2E+W%2E%22">Jung C. W.</searchLink><br /><searchLink fieldCode="AR" term="%22Lee+D%2E+G%2E%22">Lee D. G.</searchLink><br /><searchLink fieldCode="AR" term="%22Yoon+S%2E+S%2E%22">Yoon S. S.</searchLink><br /><searchLink fieldCode="AR" term="%22Lopez+Jimenez+J%2E%22">Lopez Jimenez J.</searchLink><br /><searchLink fieldCode="AR" term="%22Duran+Martinez+I%2E%22">Duran Martinez I.</searchLink><br /><searchLink fieldCode="AR" term="%22Rodriguez+Moreno+J%2E+F%2E%22">Rodriguez Moreno J. 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A.</searchLink><br /><searchLink fieldCode="AR" term="%22Ozsan+G%2E+H%2E%22">Ozsan G. H.</searchLink><br /><searchLink fieldCode="AR" term="%22Kalayoglu+Besisik+S%2E+F%2E%22">Kalayoglu Besisik S. F.</searchLink><br /><searchLink fieldCode="AR" term="%22Cagatay+A%2E%22">Cagatay A.</searchLink><br /><searchLink fieldCode="AR" term="%22Yalcin+S%2E%22">Yalcin S.</searchLink><br /><searchLink fieldCode="AR" term="%22Peniket+A%2E%22">Peniket A.</searchLink><br /><searchLink fieldCode="AR" term="%22Mullan+S%2E+R%2E%22">Mullan S. R.</searchLink><br /><searchLink fieldCode="AR" term="%22Dakhil+K%2E+M%2E%22">Dakhil K. M.</searchLink><br /><searchLink fieldCode="AR" term="%22Sivarajan+K%2E%22">Sivarajan K.</searchLink><br /><searchLink fieldCode="AR" term="%22Suh+J%2E+J%2E+-G%2E%22">Suh J. J. -G.</searchLink><br /><searchLink fieldCode="AR" term="%22Sehgal+A%2E%22">Sehgal A.</searchLink><br /><searchLink fieldCode="AR" term="%22Marquez+F%2E%22">Marquez F.</searchLink><br /><searchLink fieldCode="AR" term="%22Gomez+E%2E+G%2E%22">Gomez E. G.</searchLink><br /><searchLink fieldCode="AR" term="%22Mullane+M%2E+R%2E%22">Mullane M. R.</searchLink><br /><searchLink fieldCode="AR" term="%22Skinner+W%2E+L%2E%22">Skinner W. L.</searchLink><br /><searchLink fieldCode="AR" term="%22Behrens+R%2E+J%2E%22">Behrens R. J.</searchLink><br /><searchLink fieldCode="AR" term="%22Trevarthe+D%2E+R%2E%22">Trevarthe D. R.</searchLink><br /><searchLink fieldCode="AR" term="%22Mazurczak+M%2E+A%2E%22">Mazurczak M. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Lambiase+E%2E+A%2E%22">Lambiase E. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Vidal+C%2E+A%2E%22">Vidal C. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Anac+S%2E+Y%2E%22">Anac S. Y.</searchLink><br /><searchLink fieldCode="AR" term="%22Rodrigues+G%2E+A%2E%22">Rodrigues G. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Baltz+B%2E%22">Baltz B.</searchLink><br /><searchLink fieldCode="AR" term="%22Boccia+R%2E%22">Boccia R.</searchLink><br /><searchLink fieldCode="AR" term="%22Wertheim+M%2E+S%2E%22">Wertheim M. S.</searchLink><br /><searchLink fieldCode="AR" term="%22Holladay+C%2E+S%2E%22">Holladay C. S.</searchLink><br /><searchLink fieldCode="AR" term="%22Zenk+D%2E%22">Zenk D.</searchLink><br /><searchLink fieldCode="AR" term="%22Fusselman+W%2E%22">Fusselman W.</searchLink><br /><searchLink fieldCode="AR" term="%22Wade+III+J%2E+L%2E%22">Wade III J. L.</searchLink><br /><searchLink fieldCode="AR" term="%22Jaslowsk+A%2E+J%2E%22">Jaslowsk A. J.</searchLink><br /><searchLink fieldCode="AR" term="%22Keegan+J%2E%22">Keegan J.</searchLink><br /><searchLink fieldCode="AR" term="%22Robinson+M%2E+O%2E%22">Robinson M. O.</searchLink><br /><searchLink fieldCode="AR" term="%22Go+R%2E+S%2E%22">Go R. S.</searchLink><br /><searchLink fieldCode="AR" term="%22Farnen+J%2E%22">Farnen J.</searchLink><br /><searchLink fieldCode="AR" term="%22Amin+B%2E%22">Amin B.</searchLink><br /><searchLink fieldCode="AR" term="%22Jurgens+D%2E%22">Jurgens D.</searchLink><br /><searchLink fieldCode="AR" term="%22Risi+G%2E+F%2E%22">Risi G. F.</searchLink><br /><searchLink fieldCode="AR" term="%22Beatty+P%2E+G%2E%22">Beatty P. G.</searchLink><br /><searchLink fieldCode="AR" term="%22Naqvi+T%2E%22">Naqvi T.</searchLink><br /><searchLink fieldCode="AR" term="%22Parshad+S%2E%22">Parshad S.</searchLink><br /><searchLink fieldCode="AR" term="%22Hansen+V%2E+L%2E%22">Hansen V. L.</searchLink><br /><searchLink fieldCode="AR" term="%22Ahmed+M%2E%22">Ahmed M.</searchLink><br /><searchLink fieldCode="AR" term="%22Steen+P%2E+D%2E%22">Steen P. D.</searchLink><br /><searchLink fieldCode="AR" term="%22Badarinath+S%2E%22">Badarinath S.</searchLink><br /><searchLink fieldCode="AR" term="%22Dekker+A%2E%22">Dekker A.</searchLink><br /><searchLink fieldCode="AR" term="%22Scouros+M%2E+A%2E%22">Scouros M. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Young+D%2E+E%2E%22">Young D. E.</searchLink><br /><searchLink fieldCode="AR" term="%22Graydon+Harker+W%2E%22">Graydon Harker W.</searchLink><br /><searchLink fieldCode="AR" term="%22Kendall+S%2E+D%2E%22">Kendall S. D.</searchLink><br /><searchLink fieldCode="AR" term="%22Citron+M%2E+L%2E%22">Citron M. L.</searchLink><br /><searchLink fieldCode="AR" term="%22Chedid+S%2E%22">Chedid S.</searchLink><br /><searchLink fieldCode="AR" term="%22Posada+J%2E+G%2E%22">Posada J. G.</searchLink><br /><searchLink fieldCode="AR" term="%22Gupta+M%2E+K%2E%22">Gupta M. K.</searchLink><br /><searchLink fieldCode="AR" term="%22Rafiyath+S%2E%22">Rafiyath S.</searchLink><br /><searchLink fieldCode="AR" term="%22Buechler-Price+J%2E%22">Buechler-Price J.</searchLink><br /><searchLink fieldCode="AR" term="%22Sreenivasappa+S%2E%22">Sreenivasappa S.</searchLink><br /><searchLink fieldCode="AR" term="%22Chay+C%2E+H%2E%22">Chay C. H.</searchLink><br /><searchLink fieldCode="AR" term="%22Burke+J%2E+M%2E%22">Burke J. M.</searchLink><br /><searchLink fieldCode="AR" term="%22Young+S%2E+E%2E%22">Young S. E.</searchLink><br /><searchLink fieldCode="AR" term="%22Mahmood+A%2E%22">Mahmood A.</searchLink><br /><searchLink fieldCode="AR" term="%22Kugler+J%2E+W%2E%22">Kugler J. W.</searchLink><br /><searchLink fieldCode="AR" term="%22Gerstner+G%2E%22">Gerstner G.</searchLink><br /><searchLink fieldCode="AR" term="%22Fuloria+J%2E%22">Fuloria J.</searchLink><br /><searchLink fieldCode="AR" term="%22Belman+N%2E+D%2E%22">Belman N. D.</searchLink><br /><searchLink fieldCode="AR" term="%22Geller+R%2E%22">Geller R.</searchLink><br /><searchLink fieldCode="AR" term="%22Nieva+J%2E%22">Nieva J.</searchLink><br /><searchLink fieldCode="AR" term="%22Whittenberger+B%2E+P%2E%22">Whittenberger B. P.</searchLink><br /><searchLink fieldCode="AR" term="%22Wong+B%2E+M%2E+Y%2E%22">Wong B. M. Y.</searchLink><br /><searchLink fieldCode="AR" term="%22Cescon+T%2E+P%2E%22">Cescon T. P.</searchLink><br /><searchLink fieldCode="AR" term="%22Abesada-Terk+G%2E%22">Abesada-Terk G.</searchLink><br /><searchLink fieldCode="AR" term="%22Guarino+M%2E+J%2E%22">Guarino M. J.</searchLink><br /><searchLink fieldCode="AR" term="%22Zweibach+A%2E%22">Zweibach A.</searchLink><br /><searchLink fieldCode="AR" term="%22Ibrahim+E%2E+N%2E%22">Ibrahim E. N.</searchLink><br /><searchLink fieldCode="AR" term="%22Takahashi+G%2E%22">Takahashi G.</searchLink><br /><searchLink fieldCode="AR" term="%22Garrison+M%2E+A%2E%22">Garrison M. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Mowat+R%2E+B%2E%22">Mowat R. B.</searchLink><br /><searchLink fieldCode="AR" term="%22Choi+B%2E+S%2E%22">Choi B. S.</searchLink><br /><searchLink fieldCode="AR" term="%22Oliff+I%2E+A%2E%22">Oliff I. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Singh+J%2E%22">Singh J.</searchLink><br /><searchLink fieldCode="AR" term="%22Guter+K%2E+A%2E%22">Guter K. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Ayrons+K%2E%22">Ayrons K.</searchLink><br /><searchLink fieldCode="AR" term="%22Rowland+K%2E+M%2E%22">Rowland K. M.</searchLink><br /><searchLink fieldCode="AR" term="%22Noga+S%2E+J%2E%22">Noga S. J.</searchLink><br /><searchLink fieldCode="AR" term="%22Rao+S%2E+B%2E%22">Rao S. B.</searchLink><br /><searchLink fieldCode="AR" term="%22Columbie+A%2E%22">Columbie A.</searchLink><br /><searchLink fieldCode="AR" term="%22Nualart+M%2E+T%2E%22">Nualart M. T.</searchLink><br /><searchLink fieldCode="AR" term="%22Cecchi+G%2E+R%2E%22">Cecchi G. R.</searchLink><br /><searchLink fieldCode="AR" term="%22Campos+L%2E+T%2E%22">Campos L. T.</searchLink><br /><searchLink fieldCode="AR" term="%22Mohebtash+M%2E%22">Mohebtash M.</searchLink><br /><searchLink fieldCode="AR" term="%22Flores+M%2E+R%2E%22">Flores M. R.</searchLink><br /><searchLink fieldCode="AR" term="%22Rothstein-Rubin+R%2E%22">Rothstein-Rubin R.</searchLink><br /><searchLink fieldCode="AR" term="%22O'Connor+B%2E+M%2E%22">O'Connor B. M.</searchLink><br /><searchLink fieldCode="AR" term="%22Soori+G%2E%22">Soori G.</searchLink><br /><searchLink fieldCode="AR" term="%22Knapp+M%2E%22">Knapp M.</searchLink><br /><searchLink fieldCode="AR" term="%22Miranda+F%2E+G%2E%22">Miranda F. G.</searchLink><br /><searchLink fieldCode="AR" term="%22Goodgame+B%2E+W%2E%22">Goodgame B. 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O.<br />Couture, F.<br />Carvajal, P.<br />Yepes, A.<br />Torres Ulloa, R.<br />Fardella, P.<br />Caglevic, C.<br />Rojas, C.<br />Orellana, E.<br />Gonzalez, P.<br />Acevedo, A.<br />Galvez, K. M.<br />Gonzalez, M. E.<br />Franco, S.<br />Restrepo, J. G.<br />Rojas, C. A.<br />Bonilla, C.<br />Florez, L. E.<br />Ospina, A. V.<br />Manneh, R.<br />Zorica, R.<br />Vrdoljak, D. V.<br />Samarzija, M.<br />Petruzelka, L.<br />Vydra, J.<br />Mayer, J.<br />Cibula, D.<br />Prausova, J.<br />Paulson, G.<br />Ontaneda, M.<br />Palk, K.<br />Vahlberg, A.<br />Rooneem, R.<br />Galtier, F.<br />Postil, D.<br />Lucht, F.<br />Laine, F.<br />Launay, O.<br />Laurichesse, H.<br />Duval, X.<br />Cornely, O. A.<br />Camerer, B. ) Array ( [Name] => Publisher [Label] => Publisher Information [Group] => PubInfo [Data] => Lancet Publishing Group<br />THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND ) Array ( [Name] => DatePubCY [Label] => Publication Year [Group] => Date [Data] => 2019 ) Array ( [Name] => Subset [Label] => Collection [Group] => HoldingsInfo [Data] => Sapienza Università di Roma: CINECA IRIS ) Array ( [Name] => Subject [Label] => Subject Terms [Group] => Su [Data] => <searchLink fieldCode="DE" term="%22vaccine%22">vaccine</searchLink><br /><searchLink fieldCode="DE" term="%22varicella-zoster%22">varicella-zoster</searchLink><br /><searchLink fieldCode="DE" term="%22herpes-zoster%22">herpes-zoster</searchLink><br /><searchLink fieldCode="DE" term="%22immunocompromised%22">immunocompromised</searchLink><br /><searchLink fieldCode="DE" term="%22haematological+malignancies%22">haematological malignancies</searchLink> ) Array ( [Name] => Abstract [Label] => Description [Group] => Ab [Data] => Background Patients who are immunocompromised because of malignancy have an increased risk of herpes zoster and herpes zoster-related complications. We aimed to investigate the efficacy and safety of an inactivated varicella zoster virus (VZV) vaccine for herpes zoster prevention in patients with solid tumour or haematological malignancies.Methods This phase 3, two-ann, randomised, double-blind, placebo-controlled, inulticentre trial with an adaptive design was done in 329 centres across 40 countries. The trial included adult patients with solid tumour malignancies receiving chemotherapy and those with haematological malignancies, either receiving or not receiving chemotherapy. Patients were randomly assigned (1:1) to receive four doses of VZV vaccine inactivated by v irradiation or placebo approximately 30 days apart. The patients, investigators, trial site staff, clinical adjudication committee, and sponsor's clinical and laboratory personnel were masked to the group assignment. The primary efficacy endpoint was herpes zoster incidence in patients with solid tumour malignancies receiving chemotherapy, which was assessed in the modified intention-to-treat population (defined as all randomly assigned patients who received at least one dose of inactivated VZV vaccine or placebo). The primary safety endpoint was serious adverse events up to 28 days after the fourth dose in patients with solid tumour malignancies receiving chemotherapy. Safety endpoints were assessed in all patients who received at least one dose of inactivated VZV vaccine or placebo and had follow-up data. This trial is registered (NCT01254630 and EudraCT 2010-023156-89).Findings Between June 27, 2011, and April 11,2017,5286 patients were randomly assigned to receive VZV vaccine inactivated by gamma irradiation (n=2637) or placebo (n=2649). The haematological malignancy arm was terminated early because of evidence of futility at a planned interim analysis; therefore, all prespecified haematological malignancy endpoints were deemed exploratory. In ... ) Array ( [Name] => TypeDocument [Label] => Document Type [Group] => TypDoc [Data] => article in journal/newspaper ) Array ( [Name] => Language [Label] => Language [Group] => Lang [Data] => English ) Array ( [Name] => NoteTitleSource [Label] => Relation [Group] => SrcInfo [Data] => info:eu-repo/semantics/altIdentifier/pmid/:31399378; info:eu-repo/semantics/altIdentifier/wos/WOS:000484017800032; volume:19; issue:9; firstpage:1001; lastpage:1012; numberofpages:12; journal:THE LANCET INFECTIOUS DISEASES; http://hdl.handle.net/11573/1331005; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85071372218 ) Array ( [Name] => DOI [Label] => DOI [Group] => ID [Data] => 10.1016/S1473-3099(19)30310-X ) Array ( [Name] => URL [Label] => Availability [Group] => URL [Data] => https://doi.org/10.1016/S1473-3099(19)30310-X<br />http://hdl.handle.net/11573/1331005 ) Array ( [Name] => Copyright [Label] => Rights [Group] => Cpyrght [Data] => info:eu-repo/semantics/closedAccess ) Array ( [Name] => AN [Label] => Accession Number [Group] => ID [Data] => edsbas.CB6E58B4 ) |
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