Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years

Clinical Infectious Diseases

Volumn 54, Issue 7, 2012, Pages 922-928

  Schmader, Kenneth E ^a,b   Levin, Myron J ^c   Gnann, John W ^d,e   McNeil, Shelly A ^f   Vesikari, Timo ^g   Betts, Robert F ^h   Keay, Susan ⁱ   Stek, Jon E ^j   Bundick, Nickoya D ^j   Su, Shu Chih ^j   Zhao, Yanli ^j   Li, Xiaoming ^j   Chan, Ivan S F ^j   Annunziato, Paula W ^j   Parrino, Janie ^j  

^a DUKE UNIVERSITY   (United States)

^b DURHAM VA MEDICAL CENTER   (United States)

^c UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^e BIRMINGHAM VA MEDICAL CENTER   (United States)

^f DALHOUSIE UNIVERSITY   (Canada)

^g TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

^h UNIVERSITY OF ROCHESTER   (United States)

ⁱ VETERANS AFFAIRS MEDICAL CENTER   (United States)

^j MERCK RESEARCH LABORATORIES   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; VARICELLA ZOSTER VACCINE; VIRUS DNA;

ADULT; ARTICLE; CONFIDENCE INTERVAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EUROPE; FEMALE; HEADACHE; HERPES ZOSTER; HUMAN; INCIDENCE; INJECTION SITE REACTION; LICENCE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NORTH AMERICA; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; VACCINATION REACTION; VARICELLA ZOSTER VIRUS;

DOUBLE-BLIND METHOD; DRUG TOXICITY; EUROPE; FEMALE; HERPES ZOSTER; HERPES ZOSTER VACCINE; HUMANS; INCIDENCE; MALE; MIDDLE AGED; NORTH AMERICA; PLACEBOS;

EID: 84863289439     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cir970     Document Type: Article

References (29)

1. Gnann JW Jr, Whitley RJ. Clinical practice: herpes zoster. N Engl JMed 2002; 347:340-6.
2. Katz J, Cooper EM, Walther RR, Sweeney EW, Dworkin RH. Acute pain in herpes zoster and its impact on health-related quality of life. Clin Infect Dis 2004; 39:342-8. (Pubitemid 39050481)
3. Schmader KE, Sloane R, Pieper C, et al. The impact of acute herpes zoster pain and discomfort on functional status and quality of life in older adults. Clin J Pain 2007; 23:490-6. (Pubitemid 46956185)
4. Johnson RW, Bouhassira D, Kassianos G, Leplège A, Schmader KE, Weinke T. The impact of herpes zoster and post-herpetic neuralgia on quality-of-life. BMC Med 2010; 8:37.
5. Hempenstall K, Nurmikko TJ, Johnson RW, A'Hern RP, Rice AS. Analgesic therapy in postherpetic neuralgia: a quantitative systematic review. PLoS Med 2005; 2:e164.
6. Hope-Simpson RE. The nature of herpes zoster: a long-term study and a new hypothesis. Proc R Soc Med 1965; 58:9-20.
7. Mullooly JP, Riedlinger K, Chun C,Weinmann S, Houston H. Incidence of herpes zoster, 1997-2002. Epidemiol Infect 2005; 133:245-53.
8. Yawn BP, Saddier P, Wollan PC, St Sauver JL, Kurland MJ, Sy LS. A population-based study of the incidence and complication rates of herpes zoster before zoster vaccine introduction. Mayo Clin Proc 2007; 82:1341-9. (Pubitemid 350060129)
9. Kost RG, Straus SE. Postherpetic neuralgia-pathogenesis, treatment, and prevention. N Engl J Med 1996; 335:32-42.
10. Dworkin RH, Johnson RW, Breuer J, et al. Recommendations for the management of herpes zoster. Clin Infect Dis 2007; 44:S1-26. (Pubitemid 44956795)
11. Ragozzino MW, Melton LJ, Kurland LT, Chu CP, Perry HO. Population-based study of herpes zoster and its sequelae. Medicine (Baltimore) 1982; 61:310-6. (Pubitemid 12031812)
12. Oxman MN, Levin MJ, Johnson GR, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med 2005; 352:2271-84.
13. Zostavax (zoster vaccine, live) [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp., 2009. Available at: http://www.fda.gov/ downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm132831.pdf. Accessed 25 January 2011.
14. LevinMJ, OxmanMN, Zhang JH, et al. VZV-Specific immune responses in elderly recipients of a herpes zoster vaccine. J Infect Dis 2008; 197: 825-35. (Pubitemid 351417005)
15. Weinberg A, Zhang JH, Oxman MN, et al. VZV-Specific immune responses to herpes zoster in elderly participants in a trial of a clinically effective herpes zoster vaccine. J Infect Dis 2009; 200:1068-77.
16. Oxman MN. Zoster vaccine: current status and future prospects. Clin Infect Dis 2010; 51:197-213.
17. Miller AE. Selective decline in cellular immune response to varicellazoster in the elderly. Neurology 1980; 30:582-7. (Pubitemid 10073082)
18. Burke BL, Steele RW, Beard OW, Wood JS, Cain TD, Marmer DJ. Immune response to varicella-zoster in the aged. Arch Intern Med 1982; 142:291-3.
19. Weinberg A, Lazar AA, Zerbe G, et al. Influence of age and nature of primary infection on varicella-zoster virus-specific cell-mediated immune responses. J Infect Dis 2010; 201:1024-30.
20. Sutradhar SC, Wang WW, Schlienger K, et al. 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. Clin Vaccine Immunol 2009; 16:646-52.
21. Harbecke R, Keller PM, Oxman MN, et al. A real-time PCR assay to identify and discriminate among wild-type and vaccine strains of varicella-zoster virus and herpes simplex virus in clinical specimens. J Med Virol 2009; 81:1310-22.
22. Coplan PM, Schmader K, Nikas A, et al. Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory. J Pain 2004; 5:344-56. (Pubitemid 39164674)
23. Chan IS, Bohidar NR. Exact power and sample size for vaccine efficacy studies. Commun Stat Theory Meth 1998; 27:1305-22. (Pubitemid 128694297)
24. Kerzner B, Murray AV, Cheng E, et al. Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older. J Am Geriatr Soc 2007; 55:1499-507.
25. Gilderman LI, Lawless FJ, Nolen TM, et al. A double-blind, randomized, controlled, multicenter safety and immunogenicity study of a refrigeratorstable formulation of ZOSTAVAX-. Clin Vaccine Immunol 2008; 15:314-9. (Pubitemid 352025537)
26. Comment in: Clin Vaccine Immunol. 2009;16:1381; author reply 1381-2.
27. Schmader KE, Johnson GR, Saddier P, et al. Effect of a zoster vaccine on herpes zoster-related interference with functional status and healthrelated quality of life measures in older adults. J Am Geriatr Soc 2010; 58:1634-41.
28. Brisson M, Drolet M, Oxman M, et al. A prospective study of herpes zoster severity of illness. Clin J Pain 2010; 26:656-66.
29. White RR, Lenhart G, Singhal PK, et al. Incremental 1-year medical resource utilization and costs for patients with herpes zoster from a set of US health plans. Pharmacoeconomics 2009; 27:781-92.