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

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 stud...

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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.
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042 |a dc 
100 1 0 |a Romulo Colindres  |e author 
700 1 0 |a Valentine Wascotte  |e author 
700 1 0 |a Alain Brecx  |e author 
700 1 0 |a Christopher Clarke  |e author 
700 1 0 |a Caroline Hervé  |e author 
700 1 0 |a Joon Hyung Kim  |e author 
700 1 0 |a Myron J. Levin  |e author 
700 1 0 |a Lidia Oostvogels  |e author 
700 1 0 |a Toufik Zahaf  |e author 
700 1 0 |a Anne Schuind  |e author 
700 1 0 |a Anthony L. Cunningham  |e author 
245 0 0 |a Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials 
260 |b Taylor & Francis Group,   |c 2020-11-01T00:00:00Z. 
500 |a 2164-5515 
500 |a 2164-554X 
500 |a 10.1080/21645515.2020.1741312 
520 |a 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. 
546 |a EN 
690 |a recombinant herpes zoster vaccine 
690 |a reactogenicity 
690 |a doses 
690 |a healthcare professionals 
690 |a adverse events 
690 |a Immunologic diseases. Allergy 
690 |a RC581-607 
690 |a Therapeutics. Pharmacology 
690 |a RM1-950 
655 7 |a article  |2 local 
786 0 |n Human Vaccines & Immunotherapeutics, Vol 16, Iss 11, Pp 2628-2633 (2020) 
787 0 |n http://dx.doi.org/10.1080/21645515.2020.1741312 
787 0 |n https://doaj.org/toc/2164-5515 
787 0 |n https://doaj.org/toc/2164-554X 
856 4 1 |u https://doaj.org/article/a426b076a4c9441b8ceb65db156795c0  |z Connect to this object online.