Safety and tolerability of a high-potency zoster vaccine in adults ≥50 years of age

Stephen K. Tyring, Francisco Diaz-Mitoma, Larry G. Padget, Margarita Nunez, Gregory Poland, William M. Cassidy, Nickoya D. Bundick, Jianjun Li, Ivan S.F. Chan, Jon E. Stek, Paula W. Annunziato

Research output: Contribution to journalArticle

34 Scopus citations

Abstract

Background: Herpes zoster (HZ) incidence rises with age, especially after 50 years of age, probably due to waning varicella-zoster virus (VZV)-specific immunity. The Shingles Prevention Study [Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults, N Engl J Med 2005;352:2271-84], enrolled people ≥60 years of age and showed that zoster vaccine prevents HZ and postherpetic neuralgia (PHN), presumably through boosting VZV-specific immunity. This study of people ≥50 years of age compared the safety and tolerability of two zoster vaccine potencies. Methods: Adults ≥50 years old enrolled in a randomized, double-blind, multicenter study to compare the safety and tolerability of one dose of two zoster vaccine potencies, ∼58,000 and ∼207,000 plaque-forming units/dose. Adverse experiences (AEs) were recorded on a standardized Vaccination Report Card for 42 days postvaccination. For assessment of injection-site AEs, clinically acceptable tolerability was predefined based on experience with PNEUMOVAX™ 23, a licensed vaccine recommended for use in older people. Results: Six hundred and ninety-eight subjects (age 50-90 years, median 64 years) were enrolled. No serious vaccine-related AEs were reported. Similar AE rates were observed in the higher and lower potency groups (overall systemic AEs: 37.5 and 39.3%, vaccine-related systemic AEs: 10.9 and 13.2%, injection-site AEs: 63.0 and 59.8%). Rates for a combined endpoint of moderate or severe injection-site pain/tenderness/soreness and swelling were 17.2% (95% CI 13.9, 21.0) and 9.0% (95% CI 5.6, 13.4), respectively. Most combined endpoint events were reported as moderate in intensity. Conclusions: Both vaccine potencies were generally well tolerated in this study of people ≥50 years of age. Although rates of some moderate or severe injection-site AEs were greater in the higher potency group, all rates met the prespecified criteria for clinically acceptable tolerability.

Original languageEnglish (US)
Pages (from-to)1877-1883
Number of pages7
JournalVaccine
Volume25
Issue number10
DOIs
StatePublished - Feb 26 2007

Keywords

  • Safety
  • Tolerability
  • Zoster vaccine

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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    Tyring, S. K., Diaz-Mitoma, F., Padget, L. G., Nunez, M., Poland, G., Cassidy, W. M., Bundick, N. D., Li, J., Chan, I. S. F., Stek, J. E., & Annunziato, P. W. (2007). Safety and tolerability of a high-potency zoster vaccine in adults ≥50 years of age. Vaccine, 25(10), 1877-1883. https://doi.org/10.1016/j.vaccine.2006.10.027