{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T21:21:53Z","timestamp":1792790513790,"version":"4.5.0"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2018,9,25]],"date-time":"2018-09-25T00:00:00Z","timestamp":1537833600000},"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"}]},{"name":"Duke Pepper Older Americans Independence Center"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,7,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Herpes zoster and its related complications are associated with significant medical burden, which negatively affects quality of life and daily functioning of the patients. 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 on the quality of life and daily functioning of participants and implications for caregivers.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Four hundred and one adults aged 50 years or older 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 score following first-dose administration, quality of life, reactogenicity, safety, productivity loss, and health care resource utilization was assessed. The current analysis was performed post-vaccine dose-1; safety follow-up will continue until 1 year post-dose-2.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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 Physical Functioning score (affecting activities such as walking, carrying groceries, climbing stairs) on Days 1 and 2 post-first vaccination. No clinically meaningful reductions in mean SF-36 Physical Functioning scale scores from pre- to post-RZV dose-1 were observed (mean +1.9 points, primary end point), and no overall quality-adjusted-life-year loss was recorded post-dose-1. Five participants reported lost workdays; caregiver workload was not increased.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Overall, the physical functioning and quality of life of older adults were not affected by a first RZV dose. The observed reactogenicity was consistent with previous studies.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/gerona\/gly218","type":"journal-article","created":{"date-parts":[[2018,9,25]],"date-time":"2018-09-25T12:22:12Z","timestamp":1537878132000},"page":"1217-1224","source":"Crossref","is-referenced-by-count":34,"title":["The Impact of Reactogenicity After the First Dose of Recombinant Zoster Vaccine on the Physical Functioning and Quality of Life of Older Adults: An Open-Label, Phase III Trial"],"prefix":"10.1093","volume":"74","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":"Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora"},{"name":"Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katrijn","family":"Grupping","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"}],"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":"David","family":"Butuk","sequence":"additional","affiliation":[{"name":"Solaris Clinical Research, Meridian, Idaho"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Chen","sequence":"additional","affiliation":[{"name":"The Corvallis Clinic, Oregon"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed El","family":"Idrissi","sequence":"additional","affiliation":[{"name":"GSK, Rixensart, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurence A","family":"Fissette","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Fogarty","sequence":"additional","affiliation":[{"name":"Spartanburg Medical Research, South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Hartley","sequence":"additional","affiliation":[{"name":"Preferred Primary Care Physicians, Uniontown, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola P","family":"Klein","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Vaccine Study Center, Oakland, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Max","family":"Nevarez","sequence":"additional","affiliation":[{"name":"DaVita Medical Group, Colorado Springs, Colorado"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kari","family":"Uusinarkaus","sequence":"additional","affiliation":[{"name":"DaVita Medical Group, Colorado Springs, Colorado"}],"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":[[2018,9,25]]},"reference":[{"key":"2019071211160847100_CIT0001","doi-asserted-by":"publisher","first-page":"1766","DOI":"10.1056\/NEJMc1310369","article-title":"Herpes zoster","volume":"369","author":"Cohen","year":"2013","journal-title":"N Engl J Med"},{"key":"2019071211160847100_CIT0002","doi-asserted-by":"publisher","first-page":"1645","DOI":"10.1016\/j.vaccine.2014.01.058","article-title":"Cost-effectiveness of vaccination against herpes zoster and postherpetic neuralgia: a critical review","volume":"32","author":"Kawai","year":"2014","journal-title":"Vaccine"},{"key":"2019071211160847100_CIT0003","doi-asserted-by":"publisher","first-page":"778","DOI":"10.1136\/bmj.321.7264.778","article-title":"The management of post-herpetic neuralgia","volume":"321","author":"Cunningham","year":"2000","journal-title":"BMJ"},{"key":"2019071211160847100_CIT0004","doi-asserted-by":"publisher","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":"2019071211160847100_CIT0005","doi-asserted-by":"publisher","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":"2019071211160847100_CIT0006","doi-asserted-by":"publisher","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":"2019071211160847100_CIT0007","doi-asserted-by":"publisher","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":"2019071211160847100_CIT0008","doi-asserted-by":"publisher","first-page":"30","DOI":"10.1186\/s12877-017-0420-9","article-title":"The temporal impact of aging on the burden of herpes zoster","volume":"17","author":"Varghese","year":"2017","journal-title":"BMC Geriatr"},{"key":"2019071211160847100_CIT0009","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1007\/s40273-012-0020-7","article-title":"A systematic review of the cost effectiveness of herpes zoster vaccination","volume":"31","author":"Szucs","year":"2013","journal-title":"Pharmacoeconomics"},{"key":"2019071211160847100_CIT0010","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 Engl J Med"},{"key":"2019071211160847100_CIT0011","doi-asserted-by":"publisher","first-page":"2087","DOI":"10.1056\/NEJMoa1501184","article-title":"Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults","volume":"372","author":"Lal","year":"2015","journal-title":"N Engl J Med"},{"key":"2019071211160847100_CIT0012","doi-asserted-by":"publisher","first-page":"1051","DOI":"10.1080\/21645515.2016.1265715","article-title":"Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults \u226550 years of age with a prior history of herpes zoster: a phase III, non-randomized, open-label clinical trial","volume":"13","author":"Godeaux","year":"2017","journal-title":"Hum Vaccin Immunother"},{"key":"2019071211160847100_CIT0013","doi-asserted-by":"publisher","first-page":"A788","DOI":"10.1016\/j.jval.2017.08.2307","article-title":"Cost-effectiveness assessment of herpes zoster vaccination in Germany","volume":"20","author":"van Oorschot","year":"2017","journal-title":"Value Health"},{"key":"2019071211160847100_CIT0014","author":"Prosser"},{"key":"2019071211160847100_CIT0015","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1080\/14760584.2016.1213632","article-title":"Adjuvant system AS01: helping to overcome the challenges of modern vaccines","volume":"16","author":"Didierlaurent","year":"2017","journal-title":"Expert Rev Vaccines"},{"key":"2019071211160847100_CIT0016","volume-title":"SF-36 Physical and Mental Health Summary Scales: A Manual for Users of Version 1","author":"Ware","year":"2001","edition":"2"},{"key":"2019071211160847100_CIT0017","article-title":"The EuroQL instrument: an index of health-related quality of life","volume-title":"Quality of Life and Pharmacoeconomics in Clinical Trials","author":"Kind","year":"1996","edition":"2"},{"key":"2019071211160847100_CIT0018","doi-asserted-by":"crossref","first-page":"384","DOI":"10.1002\/1529-0131(200108)45:4<384::AID-ART352>3.0.CO;2-0","article-title":"Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities","volume":"45","author":"Angst","year":"2001","journal-title":"Arthritis Rheum"},{"key":"2019071211160847100_CIT0019","author":"Curran","year":"2016"},{"key":"2019071211160847100_CIT0020","author":"Yeh"},{"key":"2019071211160847100_CIT0021","doi-asserted-by":"publisher","first-page":"359","DOI":"10.1186\/1472-6963-13-359","article-title":"Health economic evaluation of vaccination strategies for the prevention of herpes zoster and postherpetic neuralgia in Germany","volume":"13","author":"Ultsch","year":"2013","journal-title":"BMC Health Serv Res"},{"key":"2019071211160847100_CIT0022","doi-asserted-by":"publisher","first-page":"1454","DOI":"10.1016\/j.vaccine.2008.12.024","article-title":"Estimating the cost-effectiveness of vaccination against herpes zoster in England and Wales","volume":"27","author":"Van Hoek","year":"2009","journal-title":"Vaccine"},{"key":"2019071211160847100_CIT0023","doi-asserted-by":"publisher","first-page":"317","DOI":"10.7326\/0003-4819-145-5-200609050-00004","article-title":"Cost-effectiveness of a vaccine to prevent herpes zoster and postherpetic neuralgia in older adults","volume":"145","author":"Hornberger","year":"2006","journal-title":"Ann Intern Med"},{"key":"2019071211160847100_CIT0024","doi-asserted-by":"publisher","first-page":"489","DOI":"10.7326\/M15-0093","article-title":"Cost-effectiveness of herpes zoster vaccine for persons aged 50 years","volume":"163","author":"Le","year":"2015","journal-title":"Ann Intern Med"},{"key":"2019071211160847100_CIT0025","doi-asserted-by":"publisher","first-page":"8326","DOI":"10.1016\/j.vaccine.2007.09.066","article-title":"Evaluation of the cost-effectiveness in the United States of a vaccine to prevent herpes zoster and postherpetic neuralgia in older adults","volume":"25","author":"Pellissier","year":"2007","journal-title":"Vaccine"},{"key":"2019071211160847100_CIT0026","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1186\/1478-7547-8-7","article-title":"A health economic model for evaluating a vaccine for the prevention of herpes zoster and post-herpetic neuralgia in the UK","volume":"8","author":"Moore","year":"2010","journal-title":"Cost Eff Resour Alloc"},{"key":"2019071211160847100_CIT0027","doi-asserted-by":"publisher","first-page":"2047","DOI":"10.1016\/j.vaccine.2012.01.045","article-title":"Employment related productivity loss associated with herpes zoster and postherpetic neuralgia: a 6-month prospective study","volume":"30","author":"Drolet","year":"2012","journal-title":"Vaccine"},{"key":"2019071211160847100_CIT0028","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1186\/1477-7525-3-55","article-title":"Response shift masks the treatment impact on patient reported outcomes (PROs): the example of individual quality of life in edentulous patients","volume":"3","author":"Ring","year":"2005","journal-title":"Health Qual Life Outcomes"}],"container-title":["The Journals of Gerontology: Series A"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/biomedgerontology\/article-pdf\/74\/8\/1217\/28931502\/gly218.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,9,21]],"date-time":"2019-09-21T13:37:04Z","timestamp":1569073024000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/biomedgerontology\/article\/74\/8\/1217\/5106944"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,9,25]]},"references-count":28,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2018,9,25]]},"published-print":{"date-parts":[[2019,7,12]]}},"URL":"https:\/\/doi.org\/10.1093\/gerona\/gly218","relation":{},"ISSN":["1079-5006","1758-535X"],"issn-type":[{"value":"1079-5006","type":"print"},{"value":"1758-535X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2019,8]]},"published":{"date-parts":[[2018,9,25]]}}}