Impact of Reactogenicity After Two Doses of Recombinant Zoster Vaccine Upon Physical Functioning and Quality of Life: An Open Phase III Trial in Older Adults.

The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences
Kenneth E SchmaderDesmond Curran

Abstract

Herpes zoster may significantly impact quality of life (QoL) in older adults. The recombinant zoster vaccine (RZV) is efficacious in adults aged ≥50 and older and is associated with increased reactogenicity compared to placebo. We report here on the impact of reactogenicity of the second RZV dose on the QoL and physical functioning (PF) of vaccine recipients, and summarize findings following both doses. In this single-arm study, 401 adults aged ≥50 and older were enrolled to receive two RZV doses 2 months apart. Change in mean Short Form Survey-36 (SF-36) PF and EuroQol-5 Dimension (EQ-5D) scores, reactogenicity, safety, productivity loss, and healthcare resource utilization were evaluated. In total, 391 (97.5%) participants received dose 2. Post-dose 2, the most common solicited local symptoms were injection site pain (75.1%), erythema (22.4%), and swelling (13.9%), and the most common systemic symptoms were fatigue (46.3%), headache (37.5%), and myalgia (32.9%). Grade 3 solicited (local and systemic) adverse events were reported by 61 (15.6%) participants and were associated with a transient clinically significant decrease in SF-36 PF score on Days 1-2 post-dose 2 that recovered by Day 3. Overall, no clinically important redu...Continue Reading

References

Sep 1, 2004·The Journal of Pain : Official Journal of the American Pain Society·Paul M CoplanMichael N Oxman
Jun 19, 2007·The Clinical Journal of Pain·Kenneth E SchmaderMichael N Oxman
Sep 11, 2007·Health and Quality of Life Outcomes·Sepideh S FarivarRon D Hays
May 4, 2010·Cost Effectiveness and Resource Allocation : C/E·Lee MooreAlistair McGuire
Aug 16, 2011·Journal of Medical Economics·Puneet K SinghalPatricia Saddier
Jul 19, 2013·The New England Journal of Medicine·Jeffrey I Cohen
Aug 19, 2014·BMJ : British Medical Journal·Harriet J ForbesSinéad M Langan
Apr 17, 2015·BMC Public Health·Adam GaterEmmanuelle Préaud
Apr 29, 2015·The New England Journal of Medicine·Himal LalUNKNOWN ZOE-50 Study Group
Sep 15, 2016·The New England Journal of Medicine·Anthony L CunninghamUNKNOWN ZOE-70 Study Group
Jun 30, 2018·The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences·Desmond CurranUNKNOWN ZOE-50/70 study group
Sep 27, 2018·The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences·Kenneth E SchmaderDesmond Curran
Jun 4, 2019·Human Vaccines & Immunotherapeutics·Desmond CurranKenneth E Schmader

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