Safety and tolerability of a high-potency zoster vaccine in adults >/= 50 or years of age.

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 or 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 or years of age compared the safety and tolerability of two zoster vaccine potencies.

METHODS:

Adults >/= 50 or years old enrolled in a randomized, double-blind, multicenter study to compare the safety and tolerability of one dose of two zoster vaccine potencies, approximately 58,000 and approximately 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 > or 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.

• Authors: 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, Protocol 009 Study Group
• Journal: Vaccine (Vaccine) Vol. 25 Issue 10 Pg. 1877-83 (Feb 26 2007) ISSN: 0264-410X [Print] Netherlands
• PMID: 17227688 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Herpes Zoster Vaccine

Topics

• Aged
• Aged, 80 and over
• Double-Blind Method
• Edema
• Female
• Herpes Zoster (prevention & control)
• Herpes Zoster Vaccine (administration & dosage, adverse effects)
• Humans
• Male
• Middle Aged
• Pain