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...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2020-11-01
|
| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2020.1741312 |
| _version_ | 1797677294275264512 |
|---|---|
| author | Romulo Colindres Valentine Wascotte Alain Brecx Christopher Clarke Caroline Hervé Joon Hyung Kim Myron J. Levin Lidia Oostvogels Toufik Zahaf Anne Schuind Anthony L. Cunningham |
| author_facet | Romulo Colindres Valentine Wascotte Alain Brecx Christopher Clarke Caroline Hervé Joon Hyung Kim Myron J. Levin Lidia Oostvogels Toufik Zahaf Anne Schuind Anthony L. Cunningham |
| author_sort | Romulo Colindres |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T22:43:08Z |
| format | Article |
| id | doaj.art-a426b076a4c9441b8ceb65db156795c0 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:43:08Z |
| publishDate | 2020-11-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-a426b076a4c9441b8ceb65db156795c02023-09-22T08:51:48ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2020-11-0116112628263310.1080/21645515.2020.17413121741312Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trialsRomulo Colindres0Valentine Wascotte1Alain Brecx2Christopher Clarke3Caroline Hervé4Joon Hyung Kim5Myron J. Levin6Lidia Oostvogels7Toufik Zahaf8Anne Schuind9Anthony L. Cunningham10GSKGSKGSKGSKGSKGSKUniversity of Colorado Anschutz Medical CampusGSKGSKGSKUniversity of SydneyIn 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.http://dx.doi.org/10.1080/21645515.2020.1741312recombinant herpes zoster vaccinereactogenicitydoseshealthcare professionalsadverse events |
| spellingShingle | Romulo Colindres Valentine Wascotte Alain Brecx Christopher Clarke Caroline Hervé Joon Hyung Kim Myron J. Levin Lidia Oostvogels Toufik Zahaf Anne Schuind Anthony L. Cunningham Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials Human Vaccines & Immunotherapeutics recombinant herpes zoster vaccine reactogenicity doses healthcare professionals adverse events |
| title | Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials |
| title_full | Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials |
| title_fullStr | Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials |
| title_full_unstemmed | Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials |
| title_short | Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials |
| title_sort | post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials |
| topic | recombinant herpes zoster vaccine reactogenicity doses healthcare professionals adverse events |
| url | http://dx.doi.org/10.1080/21645515.2020.1741312 |
| work_keys_str_mv | AT romulocolindres posthocanalysisofreactogenicitytrendsbetweendose1anddose2oftheadjuvantedrecombinantzostervaccineintwoparallelrandomizedtrials AT valentinewascotte posthocanalysisofreactogenicitytrendsbetweendose1anddose2oftheadjuvantedrecombinantzostervaccineintwoparallelrandomizedtrials AT alainbrecx posthocanalysisofreactogenicitytrendsbetweendose1anddose2oftheadjuvantedrecombinantzostervaccineintwoparallelrandomizedtrials AT christopherclarke posthocanalysisofreactogenicitytrendsbetweendose1anddose2oftheadjuvantedrecombinantzostervaccineintwoparallelrandomizedtrials AT carolineherve posthocanalysisofreactogenicitytrendsbetweendose1anddose2oftheadjuvantedrecombinantzostervaccineintwoparallelrandomizedtrials AT joonhyungkim posthocanalysisofreactogenicitytrendsbetweendose1anddose2oftheadjuvantedrecombinantzostervaccineintwoparallelrandomizedtrials AT myronjlevin posthocanalysisofreactogenicitytrendsbetweendose1anddose2oftheadjuvantedrecombinantzostervaccineintwoparallelrandomizedtrials AT lidiaoostvogels posthocanalysisofreactogenicitytrendsbetweendose1anddose2oftheadjuvantedrecombinantzostervaccineintwoparallelrandomizedtrials AT toufikzahaf posthocanalysisofreactogenicitytrendsbetweendose1anddose2oftheadjuvantedrecombinantzostervaccineintwoparallelrandomizedtrials AT anneschuind posthocanalysisofreactogenicitytrendsbetweendose1anddose2oftheadjuvantedrecombinantzostervaccineintwoparallelrandomizedtrials AT anthonylcunningham posthocanalysisofreactogenicitytrendsbetweendose1anddose2oftheadjuvantedrecombinantzostervaccineintwoparallelrandomizedtrials |