Health Services Research & Development

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Schmader KE, Levin MJ, Grupping K, Matthews S, Butuk D, Chen M, El Idrissi M, Fissette LA, Fogarty C, Hartley P, Klein NP, Nevarez M, Uusinarkaus K, Oostvogels L, Curran D. The impact of reactogenicity after the first dose of recombinant zoster vaccine upon the physical functioning and quality of life of older adults: an open phase III trial. The journals of gerontology. Series A, Biological sciences and medical sciences. 2018 Sep 25.
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Abstract: Background: Herpes zoster (HZ) and its related complications are associated with significant medical burden, which negatively impacts patients' quality-of-life (QoL) and daily functioning. The recently licensed recombinant zoster vaccine (RZV) offers high efficacy, but is associated with local and systemic reactions. This study assessed the impact of RZV upon the QoL and daily functioning of participants and implications for caregivers. Methods: 401 adults aged 50 years received single RZV doses at 0 and 2-months in this open-label, single-arm, multicenter study (NCT02979639). Change in mean SF-36 Physical Functioning (PF) score following first-dose administration, QoL, reactogenicity, safety, productivity loss and healthcare resource utilization were assessed. The current analysis was performed post-vaccine dose-1; safety follow-up will continue until one year post-dose-2. Results: The most common solicited local symptoms were injection-site pain (77.5%), redness (23.0%) and swelling (13.3%); the most frequent solicited systemic reactions were fatigue (33.5%), headache (28.3%) and myalgia (26.8%). Grade 3 reactogenicity occurred in 9.5% of participants and was associated with a transient clinically important decrease in SF-36 PF score (impacting activities such as walking, carrying groceries, climbing stairs) on Days 1-2 post-first-vaccination. No clinically meaningful reductions in mean SF-36 PF scale scores from pre- to post-RZV dose-1 were observed (mean +1.9 points, primary endpoint) and no overall quality-adjusted-life-year loss was recorded post-dose-1. Five participants reported lost workdays; caregiver workload was not increased. Conclusions: Overall, the PF and QoL of older adults were not affected by a first RZV dose. The observed reactogenicity was consistent with previous studies.