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

• Main Authors: Romulo Colindres (Author), Valentine Wascotte (Author), Alain Brecx (Author), Christopher Clarke (Author), Caroline Hervé (Author), Joon Hyung Kim (Author), Myron J. Levin (Author), Lidia Oostvogels (Author), Toufik Zahaf (Author), Anne Schuind (Author), Anthony L. Cunningham (Author)
• Format: Book
• Published: Taylor & Francis Group, 2020-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

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.

Item Description

2164-5515
2164-554X
10.1080/21645515.2020.1741312