دورية أكاديمية

Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older

التفاصيل البيبلوغرافية
العنوان: Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older
المؤلفون: Cunningham A. L., Lal H., Kovac M., Chlibek R., Hwang S. -J., Diez-Domingo J., Godeaux O., Levin M. J., McElhaney J. E., Puig-Barbera J., Vanden Abeele C., Vesikari T., Watanabe D., Zahaf T., Ahonen A., Athan E., Barba-Gomez J. F., Campora L., De Looze F., Downey H. J., Ghesquiere W., Gorfinkel I., Korhonen T., Leung E., McNeil S. A., Oostvogels L., Rombo L., Smetana J., Weckx L., Yeo W., Heineman T. C., Eizenberg P, Avelino-Silva TJ, Neto JL, Santos RR, Zerbini CA, Gauthier JS, Toma A, Poder A, Forsten A, Karppa T, Seppä I, Esen M, Schwarz TF, Desole MG, Icardi G, Pellegrino A, Staniscia T, Volpi A, Ikematsu H, Choi WS, Mascarenas de Los Santos A, Tinoco JC, Brotons C, Caso C, Narejos Perez S, Rodriguez de la Pinta ML, Berglund J, Blom KB, Liu B, Pauksens K, Thompson A, Andrews C, Jackson Downey H, Freedman M, Levin M, Arbi MB, Catteau G, Curran D, Marion S, Oujaa M, Ravault S, Abeele CV, Vastiau I, Junqueira T, Berndtsson Blom K, Downey H, Rodriguez ML, Zerbini C, Heineman T, Puig J
المساهمون: Cunningham, A. L., Lal, H., Kovac, M., Chlibek, R., Hwang, S. -J., Diez-Domingo, J., Godeaux, O., Levin, M. J., Mcelhaney, J. E., Puig-Barbera, J., Vanden Abeele, C., Vesikari, T., Watanabe, D., Zahaf, T., Ahonen, A., Athan, E., Barba-Gomez, J. F., Campora, L., De Looze, F., Downey, H. J., Ghesquiere, W., Gorfinkel, I., Korhonen, T., Leung, E., Mcneil, S. A., Oostvogels, L., Rombo, L., Smetana, J., Weckx, L., Yeo, W., Heineman, T. C., Athan, E, Cunningham, Al, de Looze, F, Eizenberg, P, Yeo, W, Avelino-Silva, Tj, Neto, Jl, Santos, Rr, Weckx, L, Zerbini, Ca, Gauthier, J, Ghesquiere, W, Gorfinkel, I, Mcelhaney, Je, Mcneil, Sa, Toma, A, Chlibek, R, Smetana, J, Poder, A, Ahonen, A, Forsten, A, Karppa, T, Korhonen, T, Seppä, I, Vesikari, T, Esen, M, Schwarz, Tf, Leung, E, Desole, Mg, Icardi, G, Pellegrino, A, Staniscia, T, Volpi, A, Ikematsu, H, Watanabe, D, Choi, W, Barba-Gomez, Jf, Mascarenas de Los Santos, A, Tinoco, Jc, Brotons, C, Caso, C, Diez-Domingo, J, Narejos Perez, S, Puig-Barberà, J, Rodriguez de la Pinta, Ml, Berglund, J, Blom, Kb, Liu, B, Pauksens, K, Rombo, L, Hwang, Sj, Thompson, A, Andrews, C, Jackson Downey, H, Freedman, M, Levin, M, Arbi, Mb, Campora, L, Catteau, G, Curran, D, Godeaux, O, Heineman, Tc, Kovac, M, Lal, H, Marion, S, Oostvogels, L, Oujaa, M, Ravault, S, Abeele, Cv
بيانات النشر: Massachussetts Medical Society
WALTHAM WOODS CENTER, 860 WINTER ST,, WALTHAM, MA 02451-1413 USA
سنة النشر: 2016
مصطلحات موضوعية: Aged, 80 and over, Double-Blind Method, Female, Herpes Zoster, Human, Kaplan-Meier Estimate, Male, Middle Aged, Neuralgia, Postherpetic, Risk, Vaccines, Subunit, Herpes Zoster Vaccine, psy, demo
الوصف: A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01B adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older (ZOE-70). METHODS This randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50. RESULTS In ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70 (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). Solicited reports of injection-site and systemic reactions within 7 days after injection were more frequent among HZ/su recipients than among placebo recipients (79.0% vs. 29.5%). Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two study groups. CONCLUSIONS In our trial, HZ/su .
نوع الوثيقة: article in journal/newspaper
اللغة: English
العلاقة: https://hdl.handle.net/11567/956745Test
الإتاحة: https://hdl.handle.net/11567/956745Test
حقوق: undefined
رقم الانضمام: edsbas.825A6354
قاعدة البيانات: BASE