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J Infect Dis. 2017 Dec 12;216(11):1352-1361. doi: 10.1093/infdis/jix481.

Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine Coadministered With Seasonal Influenza Vaccine in Adults Aged 50 Years or Older.

Author information

1
Central Laboratory and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital, Würzburg.
2
Aggarwal and Associates, Brampton, Ontario, Canada.
3
Gemeinschaftspraxis Dr Michael und Dr Beate Möckesch, Weinheim.
4
Klinische Forschung, Berlin, Germany.
5
GSK Vaccines, Wavre, Belgium.
6
Janssen Vaccines & Prevention, Leiden, the Netherlands.
7
GSK Vaccines, King of Prussia, Pennsylvania.
8
Genocea Biosciences, Cambridge, Massachusetts.
9
Pfizer Inc, Collegeville, Pennsylvania.

Abstract

Background:

The immunogenicity and safety of an adjuvanted herpes zoster subunit (HZ/su) vaccine when coadministered with a quadrivalent seasonal inactivated influenza vaccine (IIV4) was investigated in a phase 3, open-label, randomized clinical trial in adults aged ≥50 years.

Methods:

Subjects were randomized 1:1 to receive either HZ/su (varicella zoster virus glycoprotein E; AS01B Adjuvant System) and IIV4 at day 0 followed by a second HZ/su dose at month 2 (coadministration group), or IIV4 at month 0 and HZ/su at months 2 and 4 (control group). The primary objectives were the HZ/su vaccine response rate in the coadministration group and the noninferiority of the antibody responses to HZ/su and IIV4 in the coadministration compared with the control group. Safety information was collected throughout the duration of the study.

Results:

A total of 413 subjects were vaccinated in the coadministration group and 415 in the control group. The HZ/su vaccine response rate in the coadministration group was 95.8% (95% confidence interval, 93.3%-97.6%) and the anti-glycoprotein E GMCControl/Coadmin ratio was 1.08 (.97-1.20). The primary noninferiority objectives were met. No safety concerns were observed.

Conclusions:

No interference in the immune responses to either vaccine was observed when the vaccines were coadministered, and no safety concerns were identified.

Clinical Trials Registration:

NCT01954251.

KEYWORDS:

adjuvant; coadministration; herpes zoster; influenza; subunit vaccine

PMID:
29029224
PMCID:
PMC5853904
DOI:
10.1093/infdis/jix481
[Indexed for MEDLINE]
Free PMC Article

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