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assessments. Injection-site reactions would potentially be
much higher with adjuvant versus saline 0.9% solution.
The follow-up period has only been 3.5 years, so the longterm durability of these results remains to be proven.
Reference: Cunningham AL, et al, 2016 (ZOE-70 trial)9
Study Design: Phase 3, randomized, double-blind, international, multicenter, placebo-controlled study, and
pooled analysis (ZOE-50 and ZOE-70)
Study Funding: GlaxoSmithKline Biologicals
Patients: 13 900 adults 70 years and older; the pooled
data set (ZOE-50 and ZOE-70) consisted of 16 596 evaluable adults 70 years and older. Exclusion criteria included
history of herpes zoster, previous vaccination against varicella or herpes zoster, an immunosuppressive condition,
or chronic use of immunosuppressants or other immunemodifying drugs within 6 months prior to the first vaccine
dose (prednisone less than 20 mg/day or equivalent was
allowed). In ZOE-70, the majority of participants were
from Europe (54%) and white (76.9%) and female
(54.9%). Mean age was 75.6 years; 22.1% were 80 years
and older.
Intervention: Subjects were randomized (1:1) to receive
intramuscular injections of Shingrix 0.5 mL or placebo
(saline 0.9% solution) at month 0 and month 2; subjects
were stratified according to region and age (70-79 years
vs 80 years and older). Participants were to be followed
for at least 30 months after the second dose through
monthly contacts and annual clinic visits.
Results
Primary End Point(s)
** The incidence rate of herpes zoster per 1000 personyears was 0.9 in the Shingrix group and 9.2 in the placebo group, corresponding to an overall vaccine
efficacy of 89.8% (95% CI, 84.2%-93.7%; P < .001).
Vaccine efficacy did not differ between age groups
(90% for 70-79 years and 89.1% for 80 years and
older).
** Pooled analysis from ZOE-50 and ZOE-70 subjects
70 years of age and older showed a vaccine efficacy of
91.3% (95% CI, 86.8%-94.5%; P < .001). Vaccine
efficacy did not differ between age groups (91.3% for
70-79 years, and 91.4% for 80 years and older).
Secondary End Point(s)
** Incidence rate of postherpetic neuralgia per 1000 person-years in a pooled analysis of all eligible participants enrolled in ZOE-50 and ZOE-70 (50 years and
older) was 0.1 in the Shingrix group and 0.9 in the
placebo group, resulting in a vaccine efficacy of
91.2% (95% CI, 75.9%-97.7%; P < .001). No subjects
younger than 70 years vaccinated with Shingrix developed postherpetic neuralgia. In the pooled analysis of

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subjects 70 years and older (N = 16 596), vaccine efficacy against postherpetic neuralgia was 88.8% (95%
CI, 68.7%-97.1%; P < .001).
** During the mean follow-up period of 4 years in ZOE70, overall rates of serious adverse effects were similar between groups (16.6% with Shingrix vs 17.5%
with placebo). Solicited reports of reactions within 7
days after vaccination were noted in 79% of the
Shingrix group compared with 29.5% of the placebo
group. Grade 3 injection-site solicited reactions were
reported in 8.5% of the Shingrix group and in 0.2% of
the placebo group. In those receiving Shingrix, pain
was the most commonly reported injection-site reaction (68.7%), and fatigue was the most commonly
reported systemic reaction (32.9%). Most adverse
reactions were transient, and the median duration was
2 to 3 days for injection-site reactions, 1 to 2 days for
systemic reactions, and 1 to 2 days for grade 3
reactions.
Comments: The study was conducted in 18 countries in
Europe, North America, Latin America, and AsiaAustralia. The study design was the same as that of ZOE50, and this study was conducted concurrently at the same
sites so that data from the 2 studies could be pooled. The
only difference was that ZOE-70 consisted only of subjects 70 years and older, resulting in different age group
stratification.
Limitations: The long-term durability of vaccine
response cannot be determined with an average follow-up
period of 4 years.

Contraindications, Warnings, and
Precautions
Contraindications
Shingrix vaccine should not be administered to individuals
with a history of severe allergic reaction to a previous dose of
Shingrix or to any component of the vaccine. Reconstituted
Shingrix vaccine contains recombinant VZV glycoprotein E
antigen, sucrose, polysorbate 80, sodium dihydrogen phosphate dehydrate, dipotassium phosphate, QS-21, MPL, liposomes (dioleoyl phosphatidylcholine [DOPC] and
cholesterol), phosphate-buffered solution, disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium
chloride, and water for injection.1

Warnings and Precautions
Prior to vaccination with Shingrix, patient immunization
history should be reviewed for any vaccine sensitivity and
previous vaccination-related adverse reactions to mitigate
any potential anaphylactic reactions following Shingrix
administration.1

Table of Contents for the Digital Edition of Hospital Pharmacy - June 2018