Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation A Randomized Clinical Trial
| العنوان: | Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation A Randomized Clinical Trial |
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| المؤلفون: | Bastidas, A, de la Serna, J, El Idrissi, M, Oostvogels, L, Quittet, P, Lopez-Jimenez, J, Vural, F, Pohlreich, D, Zuckerman, T, Issa, NC, Gaidano, G, Lee, JJ, Abhyankar, S, Solano, C, de Oteyza, JP, Satlin, MJ, Schwartz, S, Campins, M, Rocci, A, Llamas, CV, Lee, DG, Tan, SM, Johnston, AM, Grigg, A, Boeckh, MJ, Campora, L, Lopez-Fauqued, M, Heineman, TC, Stadtmauer, EA, Sullivan, KM, Alonso, AA, Anagnostopoulos, A, Andreadis, C, Angelopoulou, M, Anttila, VJ, Aoun, M, Barista, I, Berkahn, L, Bloor, AJC, Broady, R, Brossart, P, Buadi, FK, Bulabois, CE, Cantin, G, Cellini, C, Chandrasekar, PH, Chauncey, T, Cuneo, A, Dadwal, SS, Dickinson, M, Eom, H, Sanfeliu, AE, Coll, CF, Flomenberg, PR, Gonzalez-Rodriguez, AP, Gottlieb, DJ, Grisariu, S, Guenther, A, Gutman, J, Hahn, U, Heinz, WJ, Heras, I, Ikeda, T, Jarque, I, Karthaus, M, Kerre, T, Kiani, A, Klein, AK, Kofla, G, Kryuchkova, IV, Kuo, CY, Kuruvilla, J, Kuvshinov, A, Kwak, JY, Lee, JH, Lepretre, S, Lie, AKW, Lucchesi, A, Maertens, J, Marijt, EWA, Munoz, CM, Michieli, M, Milliken, ST, Milpied, N, Coll, JM, Mossad, SB, Murphy, J, Matilla, MBN, Novak, J, Olney, HJ, Navarrete, RO, Cascon, MJP, Peniket, A, Penka, G, Piatkowska-Jakubas, B, Zarzuela, MP, Quiel, D, Rowley, SD, Sabry, W, Salmi, TM, Selleslag, DLD, Shea, TC, Silling, G, Sinisalo, UM, Sohn, SK, Staib, P, Szer, J, Theunissen, K, Topcuoglu, P, Tyurina, NG, Uvarov, M, Wahid, FSA, San Segundo, LY, Yegin, ZA, Yeh, SP, Yip, SF, Yoon, SS, Young, JAH, Zachee, P, Zaja, F, ZOE-HSCT Study Grp Collaborators |
| المصدر: | JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA instname r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe |
| بيانات النشر: | AMER MEDICAL ASSOC, 2019. |
| سنة النشر: | 2019 |
| الوصف: | IMPORTANCE Herpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster. OBJECTIVE To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients. DESIGN, SETTING, AND PARTICIPANTS Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT. INTERVENTIONS Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n=922) or placebo (n=924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter. MAIN OUTCOMES AND MEASURES The primary end point was occurrence of confirmed herpes zoster cases. RESULTS Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P |
| تدمد: | 0161-0414 0098-7484 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::7102e1e81d564949be13be354e28e639Test https://www.fundanet.incliva.es/publicaciones/ProdCientif/PublicacionFrw.aspx?id=3823Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.dedup.wf.001..7102e1e81d564949be13be354e28e639 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 01610414 00987484 |
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