School of Medicine, Aurora; 4University of Alabama at Birmingham, 5Birmingham Veterans Affairs Medical Center, Alabama; 6Dalhousie University,
Halifax, Nova Scotia, Canada; 7University of Tampere, Finland; 8University of Rochester, New York, 9Veterans Affairs Maryland Health Care System,
Baltimore, and 10Merck, Sharp, and Dohme Corp, Whitehouse Station, New Jersey
Herpes zoster (HZ), caused by reactivation of latent quality of life [2–5]. The incidence, severity, and duration
varicella zoster virus (VZV) within dorsal root or cranial of HZ pain and PHN increase with increasing age [6–10].
nerve ganglia, is a unilateral vesicular rash and pain in the Among individuals aged 50–59 years in the United States,
involved dermatome [1]. The acute and chronic pain the incidence of HZ is 4.2–5.3 per 1000 persons-years,
(postherpetic neuralgia [PHN]) associated with HZ in- and HZ affects 168 000–212 000 persons per year [7, 8].
terferes with daily functioning and lowers health-related A large population-based study in adults aged $22 years
showed that the proportion of people with HZ who
suffered acute pain lasting ,30 days was similar in those
Received 30 June 2011; accepted 28 October 2011; electronically published 30 aged 50–59 years and those aged 60–69 years (87% vs
January 2012.
Presented in part: 48th Annual Meeting of the Infectious Diseases Society of
83%, respectively) and that non-pain complications, such
America, Vancouver, Canada, 2010, Abstract 3363. as neurological, ocular, and skin complications, were
Correspondence: Janie Parrino, MD, Merck, Sharp, and Dohme Corp, PO Box
1000, UG3CD-28, North Wales, PA 19454-1099 (janie_parrino@merck.com).
equally frequent in the 2 age groups [11].
Clinical Infectious Diseases 2012;54(7):922–8
The Shingles Prevention Study (SPS) demonstrated
Ó The Author 2012. Published by Oxford University Press on behalf of the Infectious that the live, attenuated zoster vaccine (ZV) (Zostavax;
Diseases Society of America. All rights reserved. For Permissions, please e-mail:
journals.permissions@oup.com.
Merck Sharp & Dohme Corp., Whitehouse Station, NJ)
DOI: 10.1093/cid/cir970 reduced the burden of illness due to HZ in persons aged
Among HZ cases, mean severity-by-duration scores were similar subjects reported $1 AE in the ZV group compared with 42%
in those who received ZV (49.8) and placebo (56.0). In both in the placebo group, primarily due to different rates of
groups, the worst pain scores were highest within the first 8 days injection-site AEs (ZV, 64%; placebo, 14%; risk difference, 49.5;
after HZ onset, and then generally decreased during the re- 95% CI, 48.4–50.6). Very low proportions of injection-site AEs
mainder of the 21-day follow-up period. Among HZ cases, were rated as severe in intensity (ZV, 0.7%; placebo, 0.1%).
57.1% of subjects in the ZV group and 62.2% of subjects in Systemic clinical AEs were reported by approximately 35% and
the placebo group had 2 or more reports of worst HZ pain 34% of ZV and placebo recipients, respectively. Among the
scores $3 on the ZBPI. reported systemic AEs, 6.7% in the ZV group and 4.7% in the
Safety placebo group were deemed to be vaccine-related (risk differ-
Safety follow-up was obtained for more than 99% of subjects ence, 2.0; 95% CI, 1.4–2.6).
in each vaccination group (Table 3). Approximately 73% of The most commonly reported systemic AE was headache (ZV,
9.4%; placebo, 8.2%), which was deemed vaccine-related in 3%
Table 1. Subject Characteristics and 2% in the ZV and placebo groups, respectively. When
headache was excluded from analyses, there was no significant
Zoster Vaccine Placebo difference in vaccine-related systemic AEs between the two vac-
(N 5 11 211) (N 5 11 228) cination groups (risk difference, 1.17; 95% CI, 20.0–2.4).
No. % No. %
The proportion of subjects reporting SAEs occurring within
the 42–days period postvaccination was similar in the ZV (0.6%)
Gender
and placebo (0.5%) groups (relative risk, 1.13; 95% CI,.81–1.60).
Male 4298 38.3 4256 37.9
Female 6913 61.7 6972 62.1 The proportion of subjects reporting SAEs occurring within the
Age (y) 182 days postvaccination was also similar in the ZV (2.1%) and
Mean 6 SD 54.9 6 2.8 54.8 6 2.8 placebo (1.9%) groups (relative risk, 1.11; 95% CI, .92–1.33).
Race The only SAE assessed as vaccine-related by a study investigator
White 10, 588 94.4 10 601 94.4 was an anaphylactic reaction 15 minutes following vaccination
Black or African 468 4.2 476 4.2 in a subject in the ZV group. The subject was treated with epi-
American
Asian 80 0.7 68 0.6
nephrine and methylprednisolone. A recurrence of symptoms
Othera 75 0.7 83 0.7 required re-treatment; the event resolved later the same day.
Forty-eight subjects had fatal SAEs over the duration of the
Abbreviation: SD, standard deviation.
a
Other includes American Indian or Alaska Native, Multiracial, Native
study (18 in ZV group, 30 in placebo group). For the entire study
Hawaiian or Other Pacific Islander. population, the observed mortality rates (per 1000 person-years)
Abrreviations: CI, confidence interval; HZ, herpes zoster; ITT, intent-to-treat population; MITT, modified intent-to-treat population.
a
Total follow-up calculated as person-years.
b
Estimated incidence calculated as per 1000 person-years.
were similar in both vaccination groups (1.18 in ZV group, 20% of cases of HZ occur in adults aged 50–59 years [8], so this
1.90 in placebo group; P 5 .11). None of the deaths was study result will be of interest to clinicians who take care of
The same subject may appear in different categories but is counted only once in each category.
Abbreviations: AEs, adverse events; CI, confidence interval.
a
Determined by the investigator to be possibly, probably, or definitely related to the vaccination.
b
All deaths were determined not vaccine-related by the investigator.
c
Relative risk of 1.13 (95% CI, .81–1.60).