{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T23:13:26Z","timestamp":1782947606616,"version":"3.54.5"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2020,6,12]],"date-time":"2020-06-12T00:00:00Z","timestamp":1591920000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"GlaxoSmithKline Biologicals SA"},{"DOI":"10.13039\/100000049","name":"National Institute on Aging","doi-asserted-by":"publisher","award":["P30AG028716"],"award-info":[{"award-number":["P30AG028716"]}],"id":[{"id":"10.13039\/100000049","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,2,25]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Herpes zoster may significantly impact quality of life (QoL) in older adults. The recombinant zoster vaccine (RZV) is efficacious in adults aged \u226550 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Method<\/jats:title>\n                  <jats:p>In this single-arm study, 401 adults aged \u226550 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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\u20132 post-dose 2 that recovered by Day 3. Overall, no clinically important reduction in mean SF-36 PF scores was observed from baseline to post-dose 2 (mean change \u22120.4), and no quality-adjusted-life-year loss was recorded.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Overall, QoL and PF of RZV vaccinees were not affected by vaccine-related reactogenicity. A transient reduction was observed in the first 2 days after RZV vaccination in individuals with Grade 3 adverse events. No safety concerns were identified.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/gerona\/glaa127","type":"journal-article","created":{"date-parts":[[2020,6,12]],"date-time":"2020-06-12T18:30:44Z","timestamp":1591986644000},"page":"485-490","source":"Crossref","is-referenced-by-count":18,"title":["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"],"prefix":"10.1093","volume":"76","author":[{"given":"Kenneth E","family":"Schmader","sequence":"first","affiliation":[{"name":"Division of Geriatrics, Duke University Medical Center and GRECC, Durham Veterans Affairs Medical Center, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myron J","family":"Levin","sequence":"additional","affiliation":[{"name":"Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Chen","sequence":"additional","affiliation":[{"name":"The Corvallis Clinic, Oregon"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean","family":"Matthews","sequence":"additional","affiliation":[{"name":"Freelance c\/o GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan E","family":"Riley","sequence":"additional","affiliation":[{"name":"GSK, Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wayne","family":"Woo","sequence":"additional","affiliation":[{"name":"GSK, Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Herv\u00e9","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katrijn","family":"Grupping","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne E","family":"Schuind","sequence":"additional","affiliation":[{"name":"GSK, Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lidia","family":"Oostvogels","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7423-0111","authenticated-orcid":false,"given":"Desmond","family":"Curran","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,6,12]]},"reference":[{"key":"2021022605143467300_CIT0001","doi-asserted-by":"crossref","first-page":"1766","DOI":"10.1056\/NEJMcp1302674","article-title":"Herpes zoster","volume":"369","author":"Cohen","year":"2013","journal-title":"N Engl J Med"},{"key":"2021022605143467300_CIT0002","doi-asserted-by":"crossref","first-page":"g2911","DOI":"10.1136\/bmj.g2911","article-title":"Quantification of risk factors for herpes zoster: population-based case-control study","volume":"348","author":"Forbes","year":"2014","journal-title":"BMJ"},{"key":"2021022605143467300_CIT0003","doi-asserted-by":"crossref","first-page":"193","DOI":"10.1186\/s12889-015-1514-y","article-title":"The humanistic, economic and societal burden of herpes zoster in Europe: a critical review","volume":"15","author":"Gater","year":"2015","journal-title":"BMC Public Health"},{"key":"2021022605143467300_CIT0004","doi-asserted-by":"crossref","first-page":"1861","DOI":"10.1080\/21645515.2017.1324373","article-title":"Analysis of real-world health care costs among immunocompetent patients aged 50 years or older with herpes zoster in the United States","volume":"13","author":"Meyers","year":"2017","journal-title":"Hum Vaccin Immunother"},{"key":"2021022605143467300_CIT0005","doi-asserted-by":"crossref","first-page":"490","DOI":"10.1097\/AJP.0b013e318065b6c9","article-title":"The impact of acute herpes zoster pain and discomfort on functional status and quality of life in older adults","volume":"23","author":"Schmader","year":"2007","journal-title":"Clin J Pain"},{"key":"2021022605143467300_CIT0006","doi-asserted-by":"crossref","first-page":"344","DOI":"10.1016\/j.jpain.2004.06.001","article-title":"Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory","volume":"5","author":"Coplan","year":"2004","journal-title":"J Pain"},{"key":"2021022605143467300_CIT0007","doi-asserted-by":"crossref","first-page":"1019","DOI":"10.1056\/NEJMoa1603800","article-title":"Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older","volume":"375","author":"Cunningham","year":"2016","journal-title":"N 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