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Title: Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older
Authors: 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.
Abeele, C. Vanden
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. [UNIFESP]
Yeo, W.
Heineman, T. C.
Issue Date: 2016
Publisher: Massachusetts Medical Soc
Citation: New England Journal Of Medicine. Waltham, v. 375, n. 11, p. 1019-1032, 2016.
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 AS01(B) 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.govnumbers, NCT01165177 and NCT01165229.)
ISSN: 0028-4793
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