Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials
| العنوان: | Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials |
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| المؤلفون: | Alemnew F Dagnew, Myron J. Levin, Anne Schuind, Debora A. Rausch, Caroline Hervé, Toufik Zahaf, Zoe |
| المصدر: | Rheumatology (Oxford, England) |
| بيانات النشر: | Oxford University Press, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | rheumatoid arthritis, Male, medicine.medical_specialty, Subgroup analysis, Placebo, Herpes Zoster, law.invention, Arthritis, Rheumatoid, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Randomized controlled trial, law, Internal medicine, Post-hoc analysis, Medicine, Herpes Zoster Vaccine, Humans, Pharmacology (medical), 030212 general & internal medicine, Adverse effect, spondyloarthropathy, potential immune-mediated diseases, AcademicSubjects/MED00360, Aged, Randomized Controlled Trials as Topic, 030203 arthritis & rheumatology, varicella-zoster virus, Vaccines, Synthetic, business.industry, Incidence (epidemiology), psoriasis, Clinical Science, vaccines, Middle Aged, Clinical trial, Celiac Disease, Clinical Trials, Phase III as Topic, Spondylarthropathies, Zoster vaccine, Female, business, medicine.drug |
| الوصف: | Abstract Objective In the ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials, the adjuvanted recombinant zoster vaccine (RZV) demonstrated ≥90% efficacy in preventing herpes zoster (HZ) in all age groups ≥50 years. Given the increased HZ risk associated with certain underlying autoimmune diseases or their treatment regimes, we conducted a post hoc analysis of RZV’s efficacy against HZ and safety profile [specifically, the occurrence of serious adverse events (SAEs)] in ZOE-50/70 participants who reported pre-existing potential immune-mediated diseases (pIMDs) at enrolment and were not on immunosuppressive therapies. Methods Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomized to receive two doses of RZV or placebo 2 months apart. In this subgroup analysis of participants with at least one pIMD at enrolment, the efficacy was calculated for two-dose recipients who did not develop confirmed HZ before 30 days post-dose 2. SAE occurrence was evaluated for all participants who received at least one dose. Results Of the 14 645 RZV and 14 660 placebo recipients from the ZOE-50/70 studies, 983 and 960, respectively, reported at least one pre-existing pIMD at enrolment and were included in these analyses. The most frequent pre-existing conditions were psoriasis, spondyloarthropathy and RA. Efficacy against HZ was 90.5% (95% CI: 73.5, 97.5%) overall with the lowest being 84.4% (95% CI: 30.8, 98.3%) in the 70–79-year-old age group. SAEs and fatal SAEs were similar between RZV and placebo recipients. Conclusion In ZOE-50/70 participants with pre-existing pIMDs, RZV was highly efficacious against HZ and SAE incidence was similar between RZV and placebo recipients. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT01165177 (ZOE-50), NCT01165229 (ZOE-70). Graphical Abstract |
| اللغة: | English |
| تدمد: | 1462-0332 1462-0324 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f21def559261a3bc6f1c3de2a0cab659 http://europepmc.org/articles/PMC7937016 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....f21def559261a3bc6f1c3de2a0cab659 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14620332 14620324 |
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