Format

Send to

Choose Destination
Vaccine. 2018 Jan 2;36(1):148-154. doi: 10.1016/j.vaccine.2017.11.019. Epub 2017 Nov 22.

Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study.

Author information

1
GSK, 709 Swedeland Road, King of Prussia, PA 19406, USA. Electronic address: himallal@yahoo.com.
2
Kliiniliste Uuringute Keskus, 54 Sobra, 50160 Tartu, Estonia. Electronic address: airi.poder@std.ee.
3
GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: laura.e.campora@gsk.com.
4
GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: brecht.r.geeraerts@gsk.com.
5
GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: lidia.oostvogels@gsk.com.
6
GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: carline.c.vanden-abeele@gsk.com.
7
GSK, 709 Swedeland Road, King of Prussia, PA 19406, USA. Electronic address: thomas.heineman@genocea.com.

Abstract

BACKGROUND:

In phase III trials, 2 doses of a herpes zoster (HZ) subunit vaccine (HZ/su; 50 µg varicella-zoster virus glycoprotein E [gE] and AS01B Adjuvant System) administered 2-months apart in older adults (≥50 and ≥70 years) demonstrated >90% efficacy in preventing HZ and had a clinically acceptable safety profile. Here we report immunogenicity, reactogenicity and safety following administration of 2 HZ/su doses at intervals longer than 2 months.

METHODS:

In this Phase III, open-label trial conducted in the US and Estonia, 354 adults ≥50 years were randomized 1:1:1 to receive 2 HZ/su doses 2, 6, or 12 months apart. gE-specific humoral immune responses were evaluated at pre-vaccination, 1 and 12 months post-dose 2. Co-primary objectives were to compare immune responses to HZ/su 1 month post-dose 2 when given 6-months or 12-months apart to those administered 2-months apart. For each participant, safety information was collected from dose 1 to 12 months post-dose 2.

RESULTS:

346 participants completed the study and 343 were included in the according-to-protocol cohort for immunogenicity. One month post-dose 2, vaccine response rates were 96.5% (97.5% confidence interval [CI]: 90.4; 99.2) and 94.5% (97.5% CI: 87.6; 98.3) for the 0, 6- and 0, 12-month schedules, respectively, both schedules meeting the pre-defined criterion. Non-inferiority of anti-gE geometric mean concentrations was demonstrated for HZ/su administered on 0, 6-month compared to a 0, 2-month schedule; however, HZ/su administered on a 0, 12-month schedule did not meet the non-inferiority criterion. Injection site pain was the most commonly reported solicited adverse event (AE). 26 participants each reported at least 1 serious AE; none were assessed as related to vaccination.

CONCLUSIONS:

Immune responses to HZ/su administered at 0, 6-month were non-inferior to those elicited by a 0, 2-month schedule. HZ/su exhibited a clinically acceptable safety profile for all dosing intervals.

CLINICAL TRIALS REGISTRATION:

Clinicaltrials.gov (NCT01751165).

KEYWORDS:

HZ/su; Herpes zoster; Immunogenicity; Shingles; Vaccine; Varicella-zoster virus

PMID:
29174683
DOI:
10.1016/j.vaccine.2017.11.019
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center