Cited by 2,412Herpesvirus Infections and TreatmentsCytomegalovirus and herpesvirus researchViral Infections and Immunology Research

A Vaccine to Prevent Herpes Zoster and Postherpetic Neuralgia in Older Adults

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Oxman, M.N., Levin, M.J., Johnson, G.R., Schmader, K.E., Straus, S.E., Gelb, L.D., Arbeit, R.D., Simberkoff, M.S. +42 more·2005·New England Journal of Medicine

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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  • The live-attenuated herpes zoster vaccine reduces the incidence of herpes zoster by 51.3% and post-herpetic neuralgia by 66.5% compared to placebo.

    “A live-attenuated vaccine is available, which has been shown to reduce the incidence of herpes zoster by 51.3% (95% CI: 44.2–57.6) and of post-herpetic neuralgia, a severe complication occurring frequently in the elderly, by 66.5% (95% CI: 44.5–79.2) in the vaccinated population compared to placebo [170].”
  • The protective effect of the live-attenuated herpes zoster vaccine against post-herpetic neuralgia was independent of age, whereas clinical efficacy against herpes zoster declined to 27.6% in persons older than 69 years.

    “The protective effect against post-herpetic neuralgia was independent of age, whereas clinical efficacy against herpes zoster declined to only 27.6% in persons older than 69 years.”

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Research works printed but not linked: 4

  1. Hope-Simpson RE. Postherpetic neu- ralgia. J R Coll Gen Pract 1975;25:571-5.
  2. Kost RG, Straus SE. Postherpetic neu- ralgia -pathogenesis, treatment, and pre- vention. N Engl J Med 1996;335:32-42.
  3. Dworkin RH, Schmader KE. The treat- ment and prevention of postherpetic neural- gia. Clin Infect Dis 2003;36:877-82.
  4. Coplan PM, Schmader K, Nikas A, et al. Development of a measure of the burden of The New England Journal of Medicine Downloaded from nejm.org on August 29, 2023. For personal use only. No other uses without permission. Copyright © 2005 Massachusetts Medical Society. All rights reserved. n engl j med 352;22

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Authors
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. H., 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, G. 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.
Affiliations
  • University of California San Diego (US)
  • Durham VA Medical Center (US)
  • Duke Medical Center (US)
  • National Institutes of Health (US)
  • Washington University in St. Louis (US)
  • VA Boston Healthcare System (US)
  • VA NY Harbor Healthcare System (US)
  • Columbia University (US)
  • New Mexico VA Health Care System (US)
  • National Institute of Allergy and Infectious Diseases (US)
  • VA San Diego Healthcare System (US)
  • VA Ann Arbor Healthcare System (US)
  • Edward Hines, Jr. VA Hospital (US)
  • VA Puget Sound Health Care System (US)
  • University of Rochester Medicine (US)
  • Vanderbilt University Medical Center (US)
  • Baltimore VA Medical Center (US)
  • VA Palo Alto Health Care System (US)
  • Baylor College of Medicine (US)
  • The University of Texas at San Antonio Health Science Center (US)
  • Northport VA Medical Center (US)
  • James A. Haley Veterans' Hospital (US)
  • Lexington VA Health Care System (US)
  • University of California, Los Angeles (US)
Venue
New England Journal of Medicine
Published
2005-06-02
Volume
352
Issue
22
Pages
2271-2284
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2131041950
Cited by
2,412
References
40
Citations by year
2026: 51 · 2025: 90 · 2024: 63 · 2023: 92 · 2022: 60 · 2021: 95 · 2020: 97 · 2019: 111 · 2018: 145 · 2017: 155 · 2016: 158 · 2015: 133 · 2014: 126 · 2013: 149 · 2012: 110
FWCI
89.86
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • U.S. Department of Veterans Affairs
  • Office of Research and Development
Topics
  • Health Sciences › Medicine › Epidemiology › Herpesvirus Infections and Treatments
  • Health Sciences › Medicine › Epidemiology › Cytomegalovirus and herpesvirus research
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Viral Infections and Immunology Research
Keywords
herpes zoster, postherpetic neuralgia, varicella-zoster virus, live attenuated zoster vaccine, older adults, vaccine efficacy, disease burden, cell-mediated immunity, injection site reactions
MeSH terms
Aged, Double-Blind Method, Female, Follow-Up Studies, Herpes Zoster, Humans, Immunologic Memory, Male, Middle Aged, Neuralgia, Vaccines, Attenuated, Herpesvirus 3, Human, Virus Activation, Incidence, Cost of Illness, Chickenpox Vaccine

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