Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials

Hum Vaccin Immunother. 2020 Nov 1;16(11):2628-2633. doi: 10.1080/21645515.2020.1741312. Epub 2020 Apr 29.

Abstract

In two large clinical trials (ZOE-50 [NCT01165177] and ZOE-70 [NCT01165229]), two doses of the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster in adults ≥50 years of age. Solicited adverse events (AEs) were collected for 7 days post-each dose in a study sub-cohort. The incidence of reported solicited AEs was higher for RZV compared to placebo recipients. Since reactogenicity may contribute to a person's willingness to be vaccinated, knowing about expected reactogenicity might help keep high compliance with the second dose. This post hoc analysis assessed the intensity of solicited AEs post-dose 2 reported to the same event's intensity post-dose 1. Intensity was graded from 0 to 3, grade 3 indicating the highest severity. Of the vaccinees who did not experience a specific AE post-dose 1, 72.6-91.7% did not experience the same event after dose 2. Although the frequency of grade 3 AEs post-dose 2 was the highest in participants reporting the same AEs at grade 3 post-dose 1, 65.8-89.3% of vaccinees with grade 3 specific AEs post-dose 1 reported the same AEs at lower intensity post-dose 2. These data can help inform health-care professionals about the frequency and intensity of AEs post-dose 2 with respect to post-dose 1.

Keywords: Recombinant herpes zoster vaccine; adverse events; doses; healthcare professionals; reactogenicity.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Herpes Zoster Vaccine* / adverse effects
  • Herpes Zoster* / prevention & control
  • Herpesvirus 3, Human
  • Humans
  • Randomized Controlled Trials as Topic
  • Vaccines, Synthetic / adverse effects

Substances

  • Herpes Zoster Vaccine
  • Vaccines, Synthetic

Associated data

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

Grant support

This work was sponsored by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the conduct and analysis of the studies. GlaxoSmithKline Biologicals SA covered the costs associated with the development and the publishing of the present manuscript.