A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults

M. N. Oxman, M. J. Levin, G. R. Johnson, K. E. Schmader, S. E. Straus, L. D. Gelb, R. D. Arbeit, M. S. Simberkoff, A. A. Gershon, L. E. Davis, A. Weinberg, K. D. Boardman, H. M. Williams, J. Hongyuan Zhang, P. N. Peduzzi, C. E. Beisel, V. A. Morrison, J. C. Guatelli, P. A. Brooks, C. A. Kauffman & 30 others C. T. Pachucki, K. M. Neuzil, R. F. Betts, P. F. Wright, M. R. Griffin, P. Brunell, N. E. Soto, A. R. Marques, S. K. Keay, R. P. Goodman, D. J. Cotton, J. W. Gnann, J. Loutit, M. Holodniy, W. A. Keitel, George E Crawford, S. S. Yeh, Z. Lobo, J. F. Toney, R. N. Greenberg, P. M. Keller, R. Harbecke, A. R. Hayward, M. R. Irwin, T. C. Kyriakides, C. Y. Chan, I. S F Chan, W. W B Wang, P. W. Annunziato, J. L. Silber

Research output: Contribution to journalArticle

1665 Citations (Scopus)

Abstract

BACKGROUND The incidence and severity of herpes zoster and postherpetic neuralgia increase with age in association with a progressive decline in cell-mediated immunity to varicella-zoster virus (VZV). We tested the hypothesis that vaccination against VZV would decrease the incidence, severity, or both of herpes zoster and postherpetic neuralgia among older adults. METHODS We enrolled 38,546 adults 60 years of age or older in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated Oka/Merck VZV vaccine ("zoster vaccine"). Herpes zoster was diagnosed according to clinical and laboratory criteria. The pain and discomfort associated with herpes zoster were measured repeatedly for six months. The primary end point was the burden of illness due to herpes zoster, a measure affected by the incidence, severity, and duration of the associated pain and discomfort. The secondary end point was the incidence of postherpetic neuralgia. RESULTS More than 95 percent of the subjects continued in the study to its completion, with a median of 3.12 years of surveillance for herpes zoster. A total of 957 confirmed cases of herpes zoster (315 among vaccine recipients and 642 among placebo recipients) and 107 cases of postherpetic neuralgia (27 among vaccine recipients and 80 among placebo recipients) were included in the efficacy analysis. The use of the zoster vaccine reduced the burden of illness due to herpes zoster by 61.1 percent (P<0.001), reduced the incidence of postherpetic neuralgia by 66.5 percent (P<0.001), and reduced the incidence of herpes zoster by 51.3 percent (P<0.001). Reactions at the injection site were more frequent among vaccine recipients but were generally mild. CONCLUSIONS The zoster vaccine markedly reduced morbidity from herpes zoster and postherpetic neuralgia among older adults.

Original languageEnglish (US)
JournalNew England Journal of Medicine
Volume352
Issue number22
DOIs
StatePublished - Jun 2 2005
Externally publishedYes

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Postherpetic Neuralgia
Herpes Zoster
Vaccines
Herpes Zoster Vaccine
Human Herpesvirus 3
Incidence
Cost of Illness
Placebos
Pain
Cellular Immunity
Vaccination

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Oxman, M. N., Levin, M. J., Johnson, G. R., Schmader, K. E., Straus, S. E., Gelb, L. D., ... Silber, J. L. (2005). A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. New England Journal of Medicine, 352(22). https://doi.org/10.1056/NEJMoa051016

A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. / Oxman, M. N.; Levin, M. J.; Johnson, G. R.; Schmader, K. E.; Straus, S. E.; Gelb, L. D.; Arbeit, R. D.; Simberkoff, M. S.; Gershon, A. A.; Davis, L. E.; Weinberg, A.; Boardman, K. D.; Williams, H. M.; Zhang, J. Hongyuan; Peduzzi, P. N.; Beisel, C. E.; Morrison, V. A.; Guatelli, J. C.; Brooks, P. A.; Kauffman, C. A.; Pachucki, C. T.; Neuzil, K. M.; Betts, R. F.; Wright, P. F.; Griffin, M. R.; Brunell, P.; Soto, N. E.; Marques, A. R.; Keay, S. K.; Goodman, R. P.; Cotton, D. J.; Gnann, J. W.; Loutit, J.; Holodniy, M.; Keitel, W. A.; Crawford, George E; Yeh, S. S.; Lobo, Z.; Toney, J. F.; Greenberg, R. N.; Keller, P. M.; Harbecke, R.; Hayward, A. R.; Irwin, M. R.; Kyriakides, T. C.; Chan, C. Y.; Chan, I. S F; Wang, W. W B; Annunziato, P. W.; Silber, J. L.

In: New England Journal of Medicine, Vol. 352, No. 22, 02.06.2005.

Research output: Contribution to journalArticle

Oxman, MN, Levin, MJ, Johnson, GR, Schmader, KE, Straus, SE, Gelb, LD, Arbeit, RD, Simberkoff, MS, Gershon, AA, Davis, LE, Weinberg, A, Boardman, KD, Williams, HM, Zhang, JH, Peduzzi, PN, Beisel, CE, Morrison, VA, Guatelli, JC, Brooks, PA, Kauffman, CA, Pachucki, CT, Neuzil, KM, Betts, RF, Wright, PF, Griffin, MR, Brunell, P, Soto, NE, Marques, AR, Keay, SK, Goodman, RP, Cotton, DJ, Gnann, JW, Loutit, J, Holodniy, M, Keitel, WA, Crawford, GE, Yeh, SS, Lobo, Z, Toney, JF, Greenberg, RN, Keller, PM, Harbecke, R, Hayward, AR, Irwin, MR, Kyriakides, TC, Chan, CY, Chan, ISF, Wang, WWB, Annunziato, PW & Silber, JL 2005, 'A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults', New England Journal of Medicine, vol. 352, no. 22. https://doi.org/10.1056/NEJMoa051016
Oxman, M. N. ; Levin, M. J. ; Johnson, G. R. ; Schmader, K. E. ; Straus, S. E. ; Gelb, L. D. ; Arbeit, R. D. ; Simberkoff, M. S. ; Gershon, A. A. ; Davis, L. E. ; Weinberg, A. ; Boardman, K. D. ; Williams, H. M. ; Zhang, J. Hongyuan ; Peduzzi, P. N. ; Beisel, C. E. ; Morrison, V. A. ; Guatelli, J. C. ; Brooks, P. A. ; Kauffman, C. A. ; Pachucki, C. T. ; Neuzil, K. M. ; Betts, R. F. ; Wright, P. F. ; Griffin, M. R. ; Brunell, P. ; Soto, N. E. ; Marques, A. R. ; Keay, S. K. ; Goodman, R. P. ; Cotton, D. J. ; Gnann, J. W. ; Loutit, J. ; Holodniy, M. ; Keitel, W. A. ; Crawford, George E ; Yeh, S. S. ; Lobo, Z. ; Toney, J. F. ; Greenberg, R. N. ; Keller, P. M. ; Harbecke, R. ; Hayward, A. R. ; Irwin, M. R. ; Kyriakides, T. C. ; Chan, C. Y. ; Chan, I. S F ; Wang, W. W B ; Annunziato, P. W. ; Silber, J. L. / A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. In: New England Journal of Medicine. 2005 ; Vol. 352, No. 22.
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abstract = "BACKGROUND The incidence and severity of herpes zoster and postherpetic neuralgia increase with age in association with a progressive decline in cell-mediated immunity to varicella-zoster virus (VZV). We tested the hypothesis that vaccination against VZV would decrease the incidence, severity, or both of herpes zoster and postherpetic neuralgia among older adults. METHODS We enrolled 38,546 adults 60 years of age or older in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated Oka/Merck VZV vaccine ({"}zoster vaccine{"}). Herpes zoster was diagnosed according to clinical and laboratory criteria. The pain and discomfort associated with herpes zoster were measured repeatedly for six months. The primary end point was the burden of illness due to herpes zoster, a measure affected by the incidence, severity, and duration of the associated pain and discomfort. The secondary end point was the incidence of postherpetic neuralgia. RESULTS More than 95 percent of the subjects continued in the study to its completion, with a median of 3.12 years of surveillance for herpes zoster. A total of 957 confirmed cases of herpes zoster (315 among vaccine recipients and 642 among placebo recipients) and 107 cases of postherpetic neuralgia (27 among vaccine recipients and 80 among placebo recipients) were included in the efficacy analysis. The use of the zoster vaccine reduced the burden of illness due to herpes zoster by 61.1 percent (P<0.001), reduced the incidence of postherpetic neuralgia by 66.5 percent (P<0.001), and reduced the incidence of herpes zoster by 51.3 percent (P<0.001). Reactions at the injection site were more frequent among vaccine recipients but were generally mild. CONCLUSIONS The zoster vaccine markedly reduced morbidity from herpes zoster and postherpetic neuralgia among older adults.",
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TY - JOUR

T1 - A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults

AU - Oxman, M. N.

AU - Levin, M. J.

AU - Johnson, G. R.

AU - Schmader, K. E.

AU - Straus, S. E.

AU - Gelb, L. D.

AU - Arbeit, R. D.

AU - Simberkoff, M. S.

AU - Gershon, A. A.

AU - Davis, L. E.

AU - Weinberg, A.

AU - Boardman, K. D.

AU - Williams, H. M.

AU - Zhang, J. Hongyuan

AU - Peduzzi, P. N.

AU - Beisel, C. E.

AU - Morrison, V. A.

AU - Guatelli, J. C.

AU - Brooks, P. A.

AU - Kauffman, C. A.

AU - Pachucki, C. T.

AU - Neuzil, K. M.

AU - Betts, R. F.

AU - Wright, P. F.

AU - Griffin, M. R.

AU - Brunell, P.

AU - Soto, N. E.

AU - Marques, A. R.

AU - Keay, S. K.

AU - Goodman, R. P.

AU - Cotton, D. J.

AU - Gnann, J. W.

AU - Loutit, J.

AU - Holodniy, M.

AU - Keitel, W. A.

AU - Crawford, George E

AU - Yeh, S. S.

AU - Lobo, Z.

AU - Toney, J. F.

AU - Greenberg, R. N.

AU - Keller, P. M.

AU - Harbecke, R.

AU - Hayward, A. R.

AU - Irwin, M. R.

AU - Kyriakides, T. C.

AU - Chan, C. Y.

AU - Chan, I. S F

AU - Wang, W. W B

AU - Annunziato, P. W.

AU - Silber, J. L.

PY - 2005/6/2

Y1 - 2005/6/2

N2 - BACKGROUND The incidence and severity of herpes zoster and postherpetic neuralgia increase with age in association with a progressive decline in cell-mediated immunity to varicella-zoster virus (VZV). We tested the hypothesis that vaccination against VZV would decrease the incidence, severity, or both of herpes zoster and postherpetic neuralgia among older adults. METHODS We enrolled 38,546 adults 60 years of age or older in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated Oka/Merck VZV vaccine ("zoster vaccine"). Herpes zoster was diagnosed according to clinical and laboratory criteria. The pain and discomfort associated with herpes zoster were measured repeatedly for six months. The primary end point was the burden of illness due to herpes zoster, a measure affected by the incidence, severity, and duration of the associated pain and discomfort. The secondary end point was the incidence of postherpetic neuralgia. RESULTS More than 95 percent of the subjects continued in the study to its completion, with a median of 3.12 years of surveillance for herpes zoster. A total of 957 confirmed cases of herpes zoster (315 among vaccine recipients and 642 among placebo recipients) and 107 cases of postherpetic neuralgia (27 among vaccine recipients and 80 among placebo recipients) were included in the efficacy analysis. The use of the zoster vaccine reduced the burden of illness due to herpes zoster by 61.1 percent (P<0.001), reduced the incidence of postherpetic neuralgia by 66.5 percent (P<0.001), and reduced the incidence of herpes zoster by 51.3 percent (P<0.001). Reactions at the injection site were more frequent among vaccine recipients but were generally mild. CONCLUSIONS The zoster vaccine markedly reduced morbidity from herpes zoster and postherpetic neuralgia among older adults.

AB - BACKGROUND The incidence and severity of herpes zoster and postherpetic neuralgia increase with age in association with a progressive decline in cell-mediated immunity to varicella-zoster virus (VZV). We tested the hypothesis that vaccination against VZV would decrease the incidence, severity, or both of herpes zoster and postherpetic neuralgia among older adults. METHODS We enrolled 38,546 adults 60 years of age or older in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated Oka/Merck VZV vaccine ("zoster vaccine"). Herpes zoster was diagnosed according to clinical and laboratory criteria. The pain and discomfort associated with herpes zoster were measured repeatedly for six months. The primary end point was the burden of illness due to herpes zoster, a measure affected by the incidence, severity, and duration of the associated pain and discomfort. The secondary end point was the incidence of postherpetic neuralgia. RESULTS More than 95 percent of the subjects continued in the study to its completion, with a median of 3.12 years of surveillance for herpes zoster. A total of 957 confirmed cases of herpes zoster (315 among vaccine recipients and 642 among placebo recipients) and 107 cases of postherpetic neuralgia (27 among vaccine recipients and 80 among placebo recipients) were included in the efficacy analysis. The use of the zoster vaccine reduced the burden of illness due to herpes zoster by 61.1 percent (P<0.001), reduced the incidence of postherpetic neuralgia by 66.5 percent (P<0.001), and reduced the incidence of herpes zoster by 51.3 percent (P<0.001). Reactions at the injection site were more frequent among vaccine recipients but were generally mild. CONCLUSIONS The zoster vaccine markedly reduced morbidity from herpes zoster and postherpetic neuralgia among older adults.

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