Background The incidence and severity of herpes zoster and postherpeticneuralgia increase with age in association with a progressivedecline in cell-mediated immunity to varicellazostervirus (VZV). We tested the hypothesis that vaccination againstVZV would decrease the incidence, severity, or both of herpeszoster and postherpetic neuralgia among older adults.
Methods We enrolled 38,546 adults 60 years of age or older ina randomized, double-blind, placebo-controlled trial of an investigationallive attenuated Oka/Merck VZV vaccine ("zoster vaccine"). Herpeszoster was diagnosed according to clinical and laboratory criteria.The pain and discomfort associated with herpes zoster were measuredrepeatedly for six months. The primary end point was the burdenof 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 thestudy to its completion, with a median of 3.12 years of surveillancefor herpes zoster. A total of 957 confirmed cases of herpeszoster (315 among vaccine recipients and 642 among placebo recipients)and 107 cases of postherpetic neuralgia (27 among vaccine recipientsand 80 among placebo recipients) were included in the efficacyanalysis. The use of the zoster vaccine reduced the burden ofillness due to herpes zoster by 61.1 percent (P<0.001), reducedthe 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 vaccinerecipients but were generally mild.
Conclusions The zoster vaccine markedly reduced morbidity fromherpes zoster and postherpetic neuralgia among older adults.
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The authors' affiliations are listed in the Appendix.
Address reprint requests to Dr. Oxman at the Shingles Prevention Study (Mail code 111F-1), VA San Diego Healthcare System, 3350 La Jolla Village Dr., San Diego, CA 92161, or at mnoxman{at}ucsd.edu.
A Vaccine to Prevent Herpes Zoster
Kessler K. M., Carroll I., Gaeta R., Mackey S., Oxman M. N., Levin M. J., Johnson G. R., the Shingles Prevention Study Group , Tsai A. G., Gilden D. H.
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N Engl J Med 2005;
353:1414-1415, Sep 29, 2005.
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