Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults

Vaccine. 2016 Feb 3;34(6):863-8. doi: 10.1016/j.vaccine.2015.09.073. Epub 2015 Oct 1.


Background: An investigational subunit vaccine containing the varicella-zoster virus (VZV) glycoprotein E (gE) and the AS01B adjuvant system is being evaluated for the prevention of herpes zoster (HZ) in older adults. A phase II trial evaluating different formulations of this vaccine (containing 25μg, 50μg, or 100μg gE) was conducted in adults ≥60 years of age and showed that all formulations elicited robust cellular and humoral immune responses for up to 3 years after vaccination. In this follow-up study in subjects who received two doses of the 50μg gE/AS01B formulation (HZ/su), we assessed the persistence of the immune responses for up to 6 years after vaccination.

Methods: This phase II, open-label, multicenter, single-group trial conducted in the Czech Republic, Germany, Sweden, and the Netherlands followed 129 subjects who had received two doses (2 months apart) of HZ/su during the initial trial. Vaccine-induced immune responses (frequencies of gE-specific CD4(+) T cells expressing ≥2 activation markers and serum anti-gE antibody concentrations) were evaluated at 48, 60, and 72 months after the first HZ/su dose.

Results: Six years after vaccination with HZ/su, gE-specific cell-mediated immune responses and anti-gE antibody concentrations had decreased by 20-25% from month 36, but remained higher than the prevaccination values. At month 72, the gE-specific cell-mediated immune response was 3.8 times higher than the prevaccination value (477.3 vs. 119.4 activated gE-specific CD4(+) T cells per 10(6) cells), and the anti-gE antibody concentration was 7.3 times higher than the prevaccination value (8159.0 vs. 1121.3mIU/mL). No vaccine-related serious adverse events were reported between months 36 and 72.

Conclusions: gE-specific cellular and humoral immune responses persisted for 6 years after two-dose vaccination with HZ/su in healthy older adults. No safety concerns were identified.

Keywords: Glycoprotein E; Immunogenicity; NCT01295320; Persistence; Subunit vaccine; Varicella-zoster virus.

Publication types

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

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antibodies, Viral / blood
  • CD4-Positive T-Lymphocytes / immunology
  • Drug Combinations
  • Female
  • Follow-Up Studies
  • Herpes Zoster / prevention & control*
  • Herpes Zoster Vaccine / immunology
  • Herpes Zoster Vaccine / therapeutic use*
  • Humans
  • Immunity, Cellular*
  • Immunity, Humoral*
  • Lipid A / administration & dosage
  • Lipid A / analogs & derivatives
  • Male
  • Middle Aged
  • Saponins / administration & dosage
  • Vaccines, Subunit / immunology
  • Vaccines, Subunit / therapeutic use*
  • Viral Envelope Proteins / immunology*


  • Antibodies, Viral
  • Drug Combinations
  • Herpes Zoster Vaccine
  • Lipid A
  • Saponins
  • Vaccines, Subunit
  • Viral Envelope Proteins
  • adjuvant system 01