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N Engl J Med. 2016 Sep 15;375(11):1019-32. doi: 10.1056/NEJMoa1603800.

Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older.

Collaborators (180)

Athan E, Cunningham AL, de Looze F, Eizenberg P, Yeo W, Avelino-Silva TJ, Neto JL, Santos RR, Weckx L, Zerbini CA, Gauthier JS, 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 WS, 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, Vastiau I, Zahaf T, Godeaux O, Heineman TC, Lal H, Zahaf T, Ahonen A, Andrews C, Athan E, Junqueira T, Barba-Gomez JF, Berglund J, Berndtsson Blom K, Brotons C, Caso C, Chlibek R, Choi WS, Cunningham AL, de Looze F, Diez-Domingo J, Downey H, Eizenberg P, Esen M, Forsten A, Freedman M, Gauthier JS, Ghesquiere W, Desole MG, Hwang SJ, Icardi G, Ikematsu H, Karppa T, Korhonen T, Liu B, Mascarenas de Los Santos A, McElhaney JE, McNeil SA, Narejos Perez S, Leung E, Neto JL, Pauksens K, Pellegrino A, Poder A, Puig-Barberà J, Santos RR, Rodriguez ML, Rombo L, Schwarz TF, Seppä I, Smetana J, Staniscia T, Thompson A, Tinoco JC, Toma A, Vesikari T, Volpi A, Weckx L, Yeo W, Zerbini C, Arbi MB, Catteau G, Curran D, Marion S, Oujaa M, Abeele CV, Zahaf T, Ahonen A, Athan E, Barba-Gomez JF, Campora L, Chlibek R, Cunningham AL, de Looze F, Diez-Domingo J, Jackson Downey H, Ghesquiere W, Godeaux O, Gorfinkel I, Heineman T, Hwang SJ, Korhonen T, Kovac M, Lal H, Leung E, Levin MJ, McElhaney JE, McNeil SA, Oostvogels L, Puig J, Ravault S, Rombo L, Smetana J, Abeele CV, Vastiau I, Vesikari T, Watanabe D, Weckx L, Yeo W, Zahaf T, Chlibek R, Cunningham AL, Diez-Domingo J, Heineman T, Hwang SJ, Kovac M, Lal H, Levin MJ, McElhaney JE, Oostvogels L, Puig-Barberà J, Heineman TC.

Author information

1
From Westmead Institute for Medical Research, Westmead, NSW (A.L.C.), University of Sydney, Sydney (A.L.C.), the Department of Infectious Disease, Barwon Health, Deakin University, Geelong, VIC (E.A.), AusTrials and the Discipline of General Practice, School of Medicine, University of Queensland, Brisbane (F.L.), and Illawarra Health and Medical Research Institute, Graduate School of Medicine, University of Wollongong, Wollongong, NSW (W.Y.) - all in Australia; GSK Vaccines, King of Prussia, PA (H.L., T.C.H.); GSK Vaccines, Wavre, Belgium (M.K., O.G., C.V.A., T.Z., L.C., L.O.); Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic (R.C., J.S.); the Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taipei, Taiwan (S.-J.H.); the Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain (J.D.-D., J.P.-B.); the Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.J.L.); Health Sciences North Research Institute, Sudbury, ON (J.E.M.), the Section of Infectious Diseases, University of British Colombia, Victoria (W.G.), PrimeHealth Clinical Research, Toronto (I.G.), and the Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie University, Halifax (S.A.M.) - all in Canada; Vaccine Research Center, University of Tampere, Tampere, Finland (T.V., A.A., T.K.); the Department of Dermatology, Aichi Medical University, Nagakute, Japan (D.W.); Instituto Dermatologico de Jalisco Dr. José Barba Rubio, Zapopan, Mexico (J.F.B.-G.); Jacksonville Center for Clinical Research, Jacksonville, FL (H.J.D.); the Division of Geriatric Medicine, Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong (E.L.); Center for Clinical Research, Sörmland County Council, Eskilstuna, and Uppsala University, Uppsala - both in Sweden (L.R.); and

Abstract

BACKGROUND:

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 was found to reduce the risks of herpes zoster and postherpetic neuralgia among adults 70 years of age or older. (Funded by GlaxoSmithKline Biologicals; ZOE-50 and ZOE-70 ClinicalTrials.gov numbers, NCT01165177 and NCT01165229 .).

PMID:
27626517
DOI:
10.1056/NEJMoa1603800
[Indexed for MEDLINE]
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