Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
31216205
PubMed Central
PMC6930113
DOI
10.1080/21645515.2019.1627818
Knihovny.cz E-zdroje
- Klíčová slova
- Varicella-zoster virus, adjuvanted recombinant zoster vaccine, comorbidity, underlying chronic disease, vaccine efficacy, vaccine safety,
- MeSH
- adjuvancia imunologická aplikace a dávkování MeSH
- chronická nemoc MeSH
- herpes zoster prevence a kontrola MeSH
- imunokompromitovaný pacient MeSH
- interpretace statistických dat MeSH
- komorbidita MeSH
- lidé středního věku MeSH
- lidé MeSH
- postherpetická neuralgie imunologie prevence a kontrola MeSH
- potence vakcíny * MeSH
- rizikové faktory MeSH
- senioři MeSH
- syntetické vakcíny imunologie MeSH
- vakcína proti pásovému oparu aplikace a dávkování imunologie MeSH
- vakcinace MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- adjuvancia imunologická MeSH
- syntetické vakcíny MeSH
- vakcína proti pásovému oparu MeSH
In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ).Adults aged ≥50 or ≥70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment.At enrollment, 82.3% of RZV and 82.7% of placebo recipients reported ≥1 of the 15 selected medical conditions. Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4-97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3-99.9) in those with coronary heart disease. Moreover, efficacy remained >90% irrespective of the number of selected medical conditions reported by a participant.As indicated by the similarity of the point estimates, this post-hoc analysis suggests that RZV efficacy remains high in all selected medical conditions, as well as with increasing number of medical conditions. No safety concern was identified by the type or number of medical conditions present at enrollment.
Department of Dermatology Aichi Medical University Nagakute Japan
Department of Infectious Diseases Uppsala University Hospital Uppsala Sweden
Department of Pediatrics Federal University of Sao Paulo Sao Paulo Brazil
Departments of Pediatrics and Medicine University of Colorado Anschutz Medical Campus Aurora CO USA
Faculty of Health Sciences University of Bristol Bristol UK
Faculty of Military Health Sciences University of Defense Hradec Kralove Czech Republic
Fundación para el Fomento de la Investigación Sanitaria y Biomédica Valencia Spain
Health Sciences North Research Institute Sudbury Ontario Canada
Japan Physicians Association Tokyo Japan
Keyrus Biopharma Waterloo Belgium on behalf of GSK
PrimeHealth Clinical Research Toronto Ontario Canada
The Westmead Institute for Medical Research Westmead University of Sydney Sydney NSW Australia
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