Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals.

Journal of the American Geriatrics Society
Desmond CurranZoster-064 Study Group

Abstract

Frail participants are often under-represented in randomized trials, raising questions about outcomes of interventions in real-world settings. Frailty is strongly associated with vulnerability to illness and adverse health outcomes. We studied the impact of frailty on recombinant zoster vaccine (RZV) clinical outcomes. Data from two previously conducted phase III randomized trials of RZV were pooled. These two parent trials were conducted concurrently at the same study sites using the same methods. In the two parent studies, participants aged ≥50 years (ZOE-50 study) and ≥70 years (ZOE-70 study), respectively, were randomized 1:1 to receive two doses of RZV or placebo. In the current ZOE-Frailty study (NCT03563183), a frailty index was created using previously validated methods. Clinical outcomes assessed by frailty status included vaccine efficacy, immunogenicity, reactogenicity, and safety. Of 29,305 participants from the pooled ZOE-50 and ZOE-70 total vaccinated cohort, 92% were included in this study. Mean age was 68.8 years; 58.1% were women; 45.6% were pre-frail and 11.3% frail. The percentage of frail participants increased with age from 5.7% aged 50-59 years to 22.7% aged ≥80 years. RZV vaccine efficacy against herpes z...Continue Reading

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Citations

Feb 20, 2021·Human Vaccines & Immunotherapeutics·Desmond CurranLinda Nelsen
Feb 24, 2021·BMJ : British Medical Journal·Anthony L CunninghamMyron J Levin
May 7, 2021·Clinical Interventions in Aging·Melissa K AndrewJanet E McElhaney
May 26, 2021·MMW Fortschritte der Medizin·Anja KwetkatAndreas H Leischker

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