Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial

التفاصيل البيبلوغرافية
العنوان:	Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial
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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الوصف
DOI:	10.1016/S1473-3099(19)30310-X