{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T09:52:59Z","timestamp":1789638779340,"version":"4.0.0"},"reference-count":30,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,11,16]],"date-time":"2020-11-16T00:00:00Z","timestamp":1605484800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["agsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J American Geriatrics Society"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND\/OBJECTIVES<\/jats:title>\n                    <jats:p>Frail participants are often under\u2010represented in randomized trials, raising questions about outcomes of interventions in real\u2010world 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DESIGN\/SETTING<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PARTICIPANTS\/INTERVENTION<\/jats:title>\n                    <jats:p>In the two parent studies, participants aged \u226550 years (ZOE\u201050 study) and \u226570 years (ZOE\u201070 study), respectively, were randomized 1:1 to receive two doses of RZV or placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>MEASUREMENTS<\/jats:title>\n                    <jats:p>In the current ZOE\u2010Frailty study (NCT03563183), a frailty index was created using previously validated methods. Clinical outcomes assessed by frailty status included vaccine efficacy, immunogenicity, reactogenicity, and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Of 29,305 participants from the pooled ZOE\u201050 and ZOE\u201070 total vaccinated cohort, 92% were included in this study. Mean age was 68.8 years; 58.1% were women; 45.6% were pre\u2010frail and 11.3% frail. The percentage of frail participants increased with age from 5.7% aged 50\u201359 years to 22.7% aged \u226580 years. RZV vaccine efficacy against herpes zoster was &gt;90% for all frailty subgroups (non\u2010frail: 95.8% (95% confidence interval = 91.6\u201398.2), pre\u2010frail: 90.4% (84.4\u201394.4), frail: 90.2% (75.4\u201397.0)). The RZV group demonstrated robust anti\u2010gE antibody and gE\u2010specific CD4\n                      <jats:sup>2+<\/jats:sup>\n                      responses, with mean concentrations remaining above pre\u2010vaccination levels at least 3 years post\u2010dose two, in all frailty subgroups. In the RZV group, the percentage of participants reporting solicited adverse events tended to decrease with increasing frailty.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>The relatively nonrestrictive inclusion\/exclusion criteria in the parent ZOE studies resulted in a range of participants that included frail and pre\u2010frail older adults. RZV significantly reduced the risk of herpes zoster across all frailty subgroups.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jgs.16917","type":"journal-article","created":{"date-parts":[[2020,11,16]],"date-time":"2020-11-16T15:25:58Z","timestamp":1605540358000},"page":"744-752","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":48,"title":["Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals"],"prefix":"10.1111","volume":"69","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7423-0111","authenticated-orcid":false,"given":"Desmond","family":"Curran","sequence":"first","affiliation":[{"name":"GSK  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joon H.","family":"Kim","sequence":"additional","affiliation":[{"name":"GSK  Rockville Maryland USA"}],"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":"Christophe","family":"Dessart","sequence":"additional","affiliation":[{"name":"GSK  Wavre Belgium"}],"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 Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lidia","family":"Oostvogels","sequence":"additional","affiliation":[{"name":"GSK  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan E.","family":"Riley","sequence":"additional","affiliation":[{"name":"GSK  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth E.","family":"Schmader","sequence":"additional","affiliation":[{"name":"Division of Geriatrics, Duke University Medical Center and GRECC Durham Veterans Affairs Medical Center  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony L.","family":"Cunningham","sequence":"additional","affiliation":[{"name":"The Westmead Institute for Medical Research, Westmead University of Sydney  Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shelly A.","family":"McNeil","sequence":"additional","affiliation":[{"name":"Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority Dalhousie University  Halifax Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne E.","family":"Schuind","sequence":"additional","affiliation":[{"name":"GSK  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa K.","family":"Andrew","sequence":"additional","affiliation":[{"name":"Division of Geriatric Medicine, Department of Medicine Dalhousie University  Halifax Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"Zoster\u2010064 Study 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