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

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

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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adjuvants, Immunologic / adverse effects
  • Adjuvants, Immunologic / pharmacology*
  • Adjuvants, Pharmaceutic / administration & dosage
  • Adjuvants, Pharmaceutic / pharmacology
  • Aged
  • Antibodies, Viral / blood
  • Antibodies, Viral / immunology
  • Antibody Formation / immunology
  • Drug Combinations
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Female
  • Herpes Zoster / immunology*
  • Herpes Zoster / prevention & control*
  • Herpes Zoster Vaccine / adverse effects
  • Herpes Zoster Vaccine / immunology*
  • Herpesvirus 3, Human / immunology
  • Humans
  • Immunity, Cellular
  • Immunity, Humoral
  • Immunogenicity, Vaccine / immunology*
  • Influenza Vaccines / administration & dosage
  • Influenza Vaccines / immunology*
  • Influenza, Human / drug therapy
  • Male
  • Middle Aged
  • Seasons
  • Vaccination / methods
  • Vaccines, Inactivated
  • Vaccines, Subunit / administration & dosage
  • Vaccines, Subunit / adverse effects
  • Vaccines, Subunit / immunology*

Substances

  • Adjuvants, Immunologic
  • Adjuvants, Pharmaceutic
  • Antibodies, Viral
  • Drug Combinations
  • Herpes Zoster Vaccine
  • Influenza Vaccines
  • Vaccines, Inactivated
  • Vaccines, Subunit

Associated data

  • ClinicalTrials.gov/NCT01954251