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.
Source Information
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.
Extract |
Full Text |
PDF
N Engl J Med 2005;
353:1414-1415, Sep 29, 2005.
Correspondence
This article has been cited by other articles:
Ji, G., Niu, J., Shi, Y., Hou, L., Lu, Y., Xiong, L.
(2009). The Effectiveness of Repetitive Paravertebral Injections with Local Anesthetics and Steroids for the Prevention of Postherpetic Neuralgia in Patients with Acute Herpes Zoster. Anesth. Analg.
109: 1651-1655
[Abstract][Full Text]
McGuigan, C., Balzarini, J.
(2009). FV100 as a new approach for the possible treatment of varicella-zoster virus infection. J Antimicrob Chemother
64: 671-673
[Abstract][Full Text]
Levin, M. J., Oxman, M. N., Johnson, G. R., Zhang, J. H., Hayward, A. R., Weinberg, A., Gilderman, L. I., Chan, I. S. F., Silber, J.
(2009). Immune Response to a Refrigerator-Stable Zoster Vaccine. CVI
16: 1381-1382
[Full Text]
Fardet, L., Rybojad, M., Gain, M., Kettaneh, A., Cherin, P., Bachelez, H., Dubertret, L., Lebbe, C., Morel, P., Dupuy, A.
(2009). Incidence, Risk Factors, and Severity of Herpesvirus Infections in a Cohort of 121 Patients With Primary Dermatomyositis and Dermatomyositis Associated With a Malignant Neoplasm. Arch Dermatol
145: 889-893
[Abstract][Full Text]
Whitley, R. J.
(2009). A 70-Year-Old Woman With Shingles: Review of Herpes Zoster. JAMA
302: 73-80
[Abstract][Full Text]
SINGH, A., ENGLUND, K.
(2009). IN REPLY:. Cleveland Clinic Journal of Medicine
76: 330-330
[Full Text]
Sutradhar, S. C., Wang, W. W. B., Schlienger, K., Stek, J. E., Xu, J., Chan, I. S. F., Silber, J. L.
(2009). Comparison of the Levels of Immunogenicity and Safety of Zostavax in Adults 50 to 59 Years Old and in Adults 60 Years Old or Older. CVI
16: 646-652
[Abstract][Full Text]
Gates, I. V., Zhang, Y., Shambaugh, C., Bauman, M. A., Tan, C., Bodmer, J.-L.
(2009). Quantitative Measurement of Varicella-Zoster Virus Infection by Semiautomated Flow Cytometry. Appl. Environ. Microbiol.
75: 2027-2036
[Abstract][Full Text]
Holmes, M. V., Atabani, S. F, Khan, N., Steiner, K., Haque, T., Slapak, G.
(2009). A case for varicella vaccination in the immunosuppressed. BMJ Case Reports
2009: bcr0720080461-bcr0720080461
[Abstract][Full Text]
Chia, J. K, Chia, A. A
(2009). Varicella-zoster virus reactivation during acute enterovirus infection is associated with CD8 lymphocytopenia. BMJ Case Reports
2009: bcr0820080803-bcr0820080803
[Abstract][Full Text]
Sampathkumar, P., Drage, L. A., Martin, D. P.
(2009). Herpes Zoster (Shingles) and Postherpetic Neuralgia. Mayo Clin Proc.
84: 274-280
[Abstract][Full Text]
Strangfeld, A., Listing, J., Herzer, P., Liebhaber, A., Rockwitz, K., Richter, C., Zink, A.
(2009). Risk of Herpes Zoster in Patients With Rheumatoid Arthritis Treated With Anti-TNF-{alpha} Agents. JAMA
301: 737-744
[Abstract][Full Text]
Whitley, R. J., Gnann, J. W. Jr
(2009). Herpes Zoster in the Age of Focused Immunosuppressive Therapy. JAMA
301: 774-775
[Full Text]
Fuks, L., Shitrit, D., Fox, B. D., Amital, A., Raviv, Y., Bakal, I., Kramer, M. R.
(2009). Herpes zoster after lung transplantation: incidence, timing, and outcome.. Ann. Thorac. Surg.
87: 423-426
[Abstract][Full Text]
SINGH, A., ENGLUND, K.
(2009). Q: Who should receive the shingles vaccine?. Cleveland Clinic Journal of Medicine
76: 45-48
[Full Text]
Cho, H. J., Lavretsky, H., Olmstead, R., Levin, M. J., Oxman, M. N., Irwin, M. R.
(2008). Sleep Disturbance and Depression Recurrence in Community-Dwelling Older Adults: A Prospective Study. Am. J. Psychiatry
165: 1543-1550
[Abstract][Full Text]
Brittle, E. E., Wang, F., Lubinski, J. M., Bunte, R. M., Friedman, H. M.
(2008). A Replication-Competent, Neuronal Spread-Defective, Live Attenuated Herpes Simplex Virus Type 1 Vaccine. J. Virol.
82: 8431-8441
[Abstract][Full Text]
Higashimoto, Y., Ihira, M., Ohta, A., Inoue, S., Usui, C., Asano, Y., Yoshikawa, T.
(2008). Discriminating between Varicella-Zoster Virus Vaccine and Wild-Type Strains by Loop-Mediated Isothermal Amplification. J. Clin. Microbiol.
46: 2665-2670
[Abstract][Full Text]
Stacy, S., Pasquali, A., Sexton, V. L., Cantwell, A. M., Kraig, E., Dube, P. H.
(2008). An Age-Old Paradigm Challenged: Old Baboons Generate Vigorous Humoral Immune Responses to LcrV, A Plague Antigen. J. Immunol.
181: 109-115
[Abstract][Full Text]
Hicks, L. D., Cook-Norris, R. H., Mendoza, N., Madkan, V., Arora, A., Tyring, S. K.
(2008). Family History as a Risk Factor for Herpes Zoster: A Case-Control Study. Arch Dermatol
144: 603-608
[Abstract][Full Text]
Opstelten, W., Eekhof, J., Neven, A. K., Verheij, T.
(2008). Treatment of herpes zoster. cfp
54: 373-377
[Abstract][Full Text]
Ward, T. M., Traina-Dorge, V., Davis, K. A., Gray, W. L.
(2008). Recombinant simian varicella viruses expressing respiratory syncytial virus antigens are immunogenic. J. Gen. Virol.
89: 741-750
[Abstract][Full Text]
Weikert, B. C., Blumberg, E. A.
(2008). Viral Infection after Renal Transplantation: Surveillance and Management. CJASN
3: S76-S86
[Abstract][Full Text]
Gilderman, L. I., Lawless, J. F., Nolen, T. M., Sterling, T., Rutledge, R. Z., Fernsler, D. A., Azrolan, N., Sutradhar, S. C., Wang, W. W., Chan, I. S. F., Schlienger, K., Schodel, F., Silber, J. L., for the Zostavax Protocol 010 Study Group,
(2008). A Double-Blind, Randomized, Controlled, Multicenter Safety and Immunogenicity Study of a Refrigerator-Stable Formulation of Zostavax. CVI
15: 314-319
[Abstract][Full Text]
Gershon, A. A.
(2008). Varicella-Zoster Virus Infections. Pediatr. Rev.
29: 5-11
[Full Text]
Moss, S. M.
(2007). Emerging vaccines: Evidence and considerations for practice integration. cfp
53: 2150-2156
[Full Text]
Curtis, K. K., Vikram, H. R.
(2007). 66-Year-Old Man With Inarticulate Speech. Mayo Clin Proc.
82: 1562-1565
[Full Text]
Roderick, M., Ramanan, A. V, Finn, A.
(2007). Should the UK introduce varicella vaccine?. Arch. Dis. Child.
92: 1051-1052
[Full Text]
Roush, S. W., Murphy, T. V., and the Vaccine-Preventable Disease Table Working,
(2007). Historical Comparisons of Morbidity and Mortality for Vaccine-Preventable Diseases in the United States. JAMA
298: 2155-2163
[Abstract][Full Text]
Galluzzi, K. E.
(2007). Managing Neuropathic Pain. JAOA: Journal of the American Osteopathic Association
107: ES39-ES48
[Abstract][Full Text]
Yawn, B. P., Saddier, P., Wollan, P. C., Sauver, J. L. St., Kurland, M. J., Sy, L. S.
(2007). A Population-Based Study of the Incidence and Complication Rates of Herpes Zoster Before Zoster Vaccine Introduction. Mayo Clin Proc.
82: 1341-1349
[Abstract][Full Text]
Erard, V., Guthrie, K. A., Varley, C., Heugel, J., Wald, A., Flowers, M. E. D., Corey, L., Boeckh, M.
(2007). One-year acyclovir prophylaxis for preventing varicella-zoster virus disease after hematopoietic cell transplantation: no evidence of rebound varicella-zoster virus disease after drug discontinuation. Blood
110: 3071-3077
[Abstract][Full Text]
Zerboni, L., Reichelt, M., Jones, C. D., Zehnder, J. L., Ito, H., Arvin, A. M.
(2007). From the Cover: Aberrant infection and persistence of varicella-zoster virus in human dorsal root ganglia in vivo in the absence of glycoprotein I. Proc. Natl. Acad. Sci. USA
104: 14086-14091
[Abstract][Full Text]
Woo, E. J., Ball, R., Braun, M. M., Good, C. B., Keller, D. L., Lang, P.-O., Herrmann, F., Michel, J.-P., Senanayake, S. N.
(2007). Varicella-Zoster Vaccine. NEJM
357: 88-90
[Full Text]
Committee on Infectious Diseases,
(2007). Prevention of Varicella: Recommendations for Use of Varicella Vaccines in Children, Including a Recommendation for a Routine 2-Dose Varicella Immunization Schedule. Pediatrics
120: 221-231
[Abstract][Full Text]
Wareham, D. W, Breuer, J.
(2007). Herpes zoster. BMJ
334: 1211-1215
[Full Text]
Schott, G. D.
(2007). Pain past, present and future: the unhappy paradox of scientific advances and therapeutic standstill. Brain
130: 1704-1708
[Full Text]
Kimberlin, D. W., Whitley, R. J.
(2007). Varicella-Zoster Vaccine for the Prevention of Herpes Zoster. NEJM
356: 1338-1343
[Full Text]
Norberg, P., Liljeqvist, J.-A., Bergstrom, T., Sammons, S., Schmid, D. S., Loparev, V. N.
(2006). Complete-Genome Phylogenetic Approach to Varicella-Zoster Virus Evolution: Genetic Divergence and Evidence for Recombination. J. Virol.
80: 9569-9576
[Abstract][Full Text]
Hornberger, J., Robertus, K.
(2006). Cost-effectiveness of a vaccine to prevent herpes zoster and postherpetic neuralgia in older adults.. ANN INTERN MED
145: 317-325
[Abstract][Full Text]
Koplan, J. P., Harpaz, R.
(2006). Shingles vaccine: effective and costly or cost-effective?. ANN INTERN MED
145: 386-387
[Full Text]
Goldman, G. S.
(2006). The Case against Universal Varicella Vaccination. International Journal of Toxicology
25: 313-317
[Abstract][Full Text]
Gilron, I., Watson, C. P. N., Cahill, C. M., Moulin, D. E.
(2006). Neuropathic pain: a practical guide for the clinician.. CMAJ
175: 265-275
[Abstract][Full Text]
Gregoire, S M, van Pesch, V, Goffette, S, Peeters, A, Sindic, C J M
(2006). Polymerase chain reaction analysis and oligoclonal antibody in the cerebrospinal fluid from 34 patients with varicella-zoster virus infection of the nervous system. J. Neurol. Neurosurg. Psychiatry
77: 938-942
[Abstract][Full Text]
Knight, C. L., Fihn, S. D.
(2006). Update in General Internal Medicine. ANN INTERN MED
145: 52-61
[Full Text]
(2006). Zostavax: A New Vaccine to Reduce the Risk for Herpes Zoster in Older Adults. JWatch Infect. Diseases
2006: 12-12
[Full Text]
Gary, L., Gilden, D. H., Cohrs, R. J.
(2006). Epigenetic regulation of varicella-zoster virus open reading frames 62 and 63 in latently infected human trigeminal Ganglia.. J. Virol.
80: 4921-4926
[Abstract][Full Text]
Cohrs, R. J., Gilden, D. H., Gomi, Y., Yamanishi, K., Cohen, J. I.
(2006). Comparison of Virus Transcription during Lytic Infection of the Oka Parental and Vaccine Strains of Varicella-Zoster Virus. J. Virol.
80: 2076-2082
[Abstract][Full Text]
Fekete, T.
(2005). A varicella-zoster virus vaccine reduced the burden of illness of herpes zoster in older adults. Evid. Based Med.
10: 177-177
[Full Text]
(2005). A Vaccine Against Herpes Zoster in Older People. JWatch Neurology
2005: 5-5
[Full Text]
Poland, G. A.
(2005). The Growing Paradigm of Preventing Disease: Vaccines To Prevent Herpes Zoster and Pertussis in Adults. ANN INTERN MED
143: 539-541
[Full Text]
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.
(2005). A vaccine to prevent herpes zoster.. NEJM
353: 1414-1415
[Full Text]
(2005). Herpes zoster vaccine is safe and effective for older adults. BMJ
331: -
[Full Text]
Galluzzi, K. E.
(2005). Management of Neuropathic Pain. JAOA: Journal of the American Osteopathic Association
105: S12-S19
[Abstract][Full Text]
Tenser, R. B., Dworkin, R. H.
(2005). Herpes zoster and the prevention of postherpetic neuralgia: Beyond antiviral therapy. Neurology
65: 349-350
[Full Text]
Weir, E.
(2005). Vaccination boosts adult immunity to varicella zoster virus. CMAJ
173: 249-249
[Full Text]
(2005). A Vaccine to Prevent Herpes Zoster in Elders. JWatch Women's Health
2005: 6-6
[Full Text]
(2005). A Vaccine to Prevent Shingles. JWatch Gastroenterology
2005: 10-10
[Full Text]