Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials

Vaccine. 2019 Oct 8;37(43):6262-6267. doi: 10.1016/j.vaccine.2019.09.028. Epub 2019 Sep 16.

Abstract

Background: Herpes zoster (HZ) risk appears to vary by sex and geographic ancestry/ethnicity.

Methods: In 2 randomized clinical trials, participants received 2 doses of adjuvanted recombinant zoster vaccine (RZV) or placebo intramuscularly, 2 months apart. In this post-hoc analysis, we investigate efficacy of RZV against HZ and postherpetic neuralgia (PHN) by sex, geographic region, and geographic ancestry/ethnicity in ≥50-year-olds (ZOE-50: NCT01165177) and ≥70-year-olds (pooled data from ZOE-50 and ZOE-70: NCT01165229).

Results: Vaccine efficacy against HZ or PHN was similar in women and men. Across geographic regions, efficacy against HZ ranged between 95.7 and 97.2% in ≥50-year-olds, and between 87.3% and 95.1% in ≥70-year-olds; efficacy against PHN ranged between 86.8 and 100% in ≥70-year-olds. Across ancestral/ethnic groups, efficacy ranged between 88.1 and 100% against HZ and between 65.9 and 100% against PHN in ≥70-year-olds.

Conclusions: While the ZOE-50/70 studies were not powered or pre-designed for these post-hoc analyses, RZV appears efficacious against HZ and PHN irrespective of sex, region, or geographic ancestry/ethnicity.

Keywords: Efficacy; Geographic ancestry/ethnicity; Herpes zoster; Recombinant zoster vaccine; Region; Sex.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / administration & dosage*
  • Aged
  • Aged, 80 and over
  • Data Interpretation, Statistical
  • Ethnic Groups
  • Female
  • Geography
  • Herpes Zoster / prevention & control*
  • Herpes Zoster Vaccine / genetics
  • Herpes Zoster Vaccine / immunology*
  • Herpesvirus 3, Human
  • Humans
  • Male
  • Middle Aged
  • Neuralgia, Postherpetic / prevention & control
  • Sex Factors
  • Vaccine Potency*
  • Vaccines, Subunit / administration & dosage
  • Vaccines, Subunit / immunology
  • Vaccines, Synthetic / administration & dosage
  • Vaccines, Synthetic / immunology

Substances

  • Adjuvants, Immunologic
  • Herpes Zoster Vaccine
  • Vaccines, Subunit
  • Vaccines, Synthetic

Associated data

  • ClinicalTrials.gov/NCT01165177
  • ClinicalTrials.gov/NCT01165229