دورية أكاديمية
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, Adriana, de la Serna, Javier, El Idrissi, Mohamed, Oostvogels, Lidia, Quittet, Philippe, Lopez-Jimenez, Javier, Vural, Filiz, Pohlreich, David, Zuckerman, Tsila, Issa, Nicolas C, Gaidano, Gianluca, Lee, Je-Jung, Abhyankar, Sunil, Solano, Carlos, Perez de Oteyza, Jaime, Satlin, Michael J, Schwartz, Stefan, Campins, Magda, Rocci, Alberto, Llamas, Carlos Vallejo, Lee, Dong-Gun, Tan, Sen Mui, Johnston, Anna M, Grigg, Andrew, Boeckh, Michael J, Campora, Laura, Lopez-Fauqued, Marta, Heineman, Thomas C, Stadtmauer, Edward A, Sullivan, Keith M, Alonso Alonso, Aranzazu, Anagnostopoulos, Achilles, Andreadis, Charalambos (Babis), Angelopoulou, Maria, Anttila, Veli-Jukka, Aoun, Mickael, Barista, Ibrahim, Berkahn, Leanne, Bloor, Adrian JC, Broady, Raewyn, Brossart, Peter, Buadi, Francis K, Bulabois, Claude-Eric, Cantin, Guy, Cellini, Claudia, Chandrasekar, Pranatharthi Haran, Chauncey, Thomas, Cuneo, Antonio, Dadwal, Sanjeet Singh, Dickinson, Michael, Eom, HyeonSeok, Esquirol Sanfeliu, Albert, Ferra Coll, Christelle, Flomenberg, Phyllis R, Gonzalez-Rodriguez, Ana Pilar, Gottlieb, David J, Grisariu, Sigal, Guenther, Andreas, Gutman, Jonathan, Hahn, Uwe, Heinz, Werner J, Heras, Inmaculda, Ikeda, Takashi, Jarque, Isidro, Karthaus, Meinolf, Kerre, Tessa, Kiani, Alexander, Klein, Andreas K, Kofla, Grzegorz, Kryuchkova, Irina V, Kuo, Ching-Yuan, Kuruvilla, John, Kuvshinov, Aleksey, Kwak, Jae-Yong, Lee, Jae Hoon, Lepretre, Stephane, Lie, Albert Kwok-Wai, Lucchesi, Alessandro, Maertens, Johan, Marijt, Erik WA, Martinez Munoz, Carmen, Michieli, Mariagrazia, Milliken, Samuel T, Milpied, Noel, Monserrat Coll, Jorge, Mossad, Sherif Beniameen, Murphy, John, Navarro Matilla, Maria Belen, Novak, Jan, Olney, Harold J, Ona Navarrete, Raquel, Pascual Cascon, Maria Jesus, Peniket, Andy, Penka, Ganeva, Piatkowska-Jakubas, Beata, Polo Zarzuela, Marta, Quiel, Dimas, Rowley, Scott D, Sabry, Waleed, Salmi, Tommi Mikael, Selleslag, Dominik LD, Shea, Thomas C, Silling, Gerda, Sinisalo, Ulla Marjatta, Sohn, Sang Kyun, Staib, Peter, Szer, Jeff, Theunissen, Koen, Topcuoglu, Pervin, Tyurina, Natalya G, Uvarov, Mikhail, Wahid, Fadilah S Abdul, Yanez San Segundo, Lucrecia, Yegin, Zeynep Arzu, Yeh, Su-Peng, Yip, Sze-Fai, Yoon, Sung Soo, Young, Jo-Anne H, Zachee, Pierre, Zaja, Francesco |
| المصدر: | JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION ; ISSN: 0098-7484 ; ISSN: 1538-3598 |
| سنة النشر: | 2019 |
| المجموعة: | Ghent University Academic Bibliography |
| مصطلحات موضوعية: | Medicine and Health Sciences, SUBUNIT VACCINE, ANTIVIRAL PROPHYLAXIS, VIRUS, RECIPIENTS, IMMUNITY, SAFETY, EFFICACY, ADULTS |
| 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<.001), equivalent to 68.2% vaccine efficacy. Of 8 secondary end points, 3 showed significant reductions in incidence of postherpetic neuralgia (vaccine, n=1; placebo, n=9; IRR, 0.1; 95% CI, 0.00-0.78; P=.02) and of other prespecified herpes zoster-related complications (vaccine, n=3; placebo, n=13; IRR, 0.22; 95% CI, 0.04-0.81; P=.02) and in duration of severe worst herpes zoster-associated pain (vaccine, 892.0 days; placebo, 6275.0 days; hazard ratio, 0.62; 95% CI, 0.42-0.89; P=.01). Five secondary objectives were descriptive. Injection site reactions were recorded in ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://biblio.ugent.be/publication/8647063Test; http://hdl.handle.net/1854/LU-8647063Test; http://dx.doi.org/10.1001/jama.2019.9053Test; https://biblio.ugent.be/publication/8647063/file/8647064Test |
| DOI: | 10.1001/jama.2019.9053 |
| الإتاحة: | https://doi.org/10.1001/jama.2019.9053Test https://biblio.ugent.be/publication/8647063Test http://hdl.handle.net/1854/LU-8647063Test https://biblio.ugent.be/publication/8647063/file/8647064Test |
| حقوق: | No license (in copyright) ; info:eu-repo/semantics/restrictedAccess |
| رقم الانضمام: | edsbas.12D4951F |
| قاعدة البيانات: | BASE |
| DOI: | 10.1001/jama.2019.9053 |
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