Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older
To determine the efficacy of an adjuvanted recombinant zoster vaccine in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living, and HZ impact on quality of life. The assessments were integrated in two Phase III trials, ZOE-50 (NCT01165177) and Z...
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| Veröffentlicht in: | The journals of gerontology. Series A, Biological sciences and medical sciences Biological sciences and medical sciences, 2019-07, Vol.74 (8), p.1231-1238 |
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| creator | Curran, Desmond Oostvogels, Lidia Heineman, Thomas Matthews, Sean McElhaney, Janet McNeil, Shelly Diez-Domingo, Javier Lal, Himal Andrews, Charles Athan, Eugene Berglund, Johan Campora, Laura de Looze, Ferdinandus Korhonen, Tiina Leung, Edward Levin, Myron Volpi, Antonio Johnson, Robert W |
| description | To determine the efficacy of an adjuvanted recombinant zoster vaccine in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living, and HZ impact on quality of life.
The assessments were integrated in two Phase III trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). HZ burden of illness and HZ burden of interference with activities of daily living were assessed by the Zoster Brief Pain Inventory (ZBPI) instrument and quality of life by the EuroQol-5 Dimension (EQ-5D) utility index and the SF-36 health survey. We report the ZOE-50 results and a pooled analysis of patients aged 70 years and older from the trials combined.
The estimated vaccine efficacy in reducing HZ burden of illness and HZ burden of interference was greater than 90% in both the ZOE-50 and the pooled ZOE-70 analysis. In confirmed HZ cases, adjuvanted recombinant zoster vaccine reduced the maximal ZBPI worst-pain score in the pooled ZOE-70 analysis (p = .032) and the maximal ZBPI average-pain scores in both the ZOE-50 (p = .049) and the pooled ZOE-70 analysis (p = .043). In breakthrough HZ cases, trends for diminished loss of quality of life compared with placebo-recipient HZ cases were observed, with differences up to 0.14 on the EQ-5D index at time points during the 4 weeks following HZ onset.
Adjuvanted recombinant zoster vaccine reduced the HZ burden of illness significantly, particularly due to its very high vaccine efficacy in preventing HZ. For breakthrough HZ cases, the results suggest that the adjuvanted recombinant zoster vaccine mitigated severity of HZ-related pain, burden of interference with activities of daily living, and recipients' utility loss. |
| doi_str_mv | 10.1093/gerona/gly150 |
| format | Article |
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The assessments were integrated in two Phase III trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). HZ burden of illness and HZ burden of interference with activities of daily living were assessed by the Zoster Brief Pain Inventory (ZBPI) instrument and quality of life by the EuroQol-5 Dimension (EQ-5D) utility index and the SF-36 health survey. We report the ZOE-50 results and a pooled analysis of patients aged 70 years and older from the trials combined.
The estimated vaccine efficacy in reducing HZ burden of illness and HZ burden of interference was greater than 90% in both the ZOE-50 and the pooled ZOE-70 analysis. In confirmed HZ cases, adjuvanted recombinant zoster vaccine reduced the maximal ZBPI worst-pain score in the pooled ZOE-70 analysis (p = .032) and the maximal ZBPI average-pain scores in both the ZOE-50 (p = .049) and the pooled ZOE-70 analysis (p = .043). In breakthrough HZ cases, trends for diminished loss of quality of life compared with placebo-recipient HZ cases were observed, with differences up to 0.14 on the EQ-5D index at time points during the 4 weeks following HZ onset.
Adjuvanted recombinant zoster vaccine reduced the HZ burden of illness significantly, particularly due to its very high vaccine efficacy in preventing HZ. For breakthrough HZ cases, the results suggest that the adjuvanted recombinant zoster vaccine mitigated severity of HZ-related pain, burden of interference with activities of daily living, and recipients' utility loss.</description><identifier>ISSN: 1079-5006</identifier><identifier>EISSN: 1758-535X</identifier><identifier>DOI: 10.1093/gerona/gly150</identifier><identifier>PMID: 29955836</identifier><language>eng</language><publisher>United States: Oxford University Press</publisher><subject>Activities of daily living ; Adjuvants ; Clinical trials ; Combined vaccines ; Herpes viruses ; Herpes zoster ; Pain ; Quality of life ; The Journal of Gerontology: Translational Section ; Vaccine efficacy ; Vaccines</subject><ispartof>The journals of gerontology. Series A, Biological sciences and medical sciences, 2019-07, Vol.74 (8), p.1231-1238</ispartof><rights>The Author(s) 2018. Published by Oxford University Press on behalf of The Gerontological Society of America.</rights><rights>Copyright Oxford University Press Aug 2019</rights><rights>The Author(s) 2018. Published by Oxford University Press on behalf of The Gerontological Society of America. 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c415t-1fb96b9cf0041b21167b33baffe4c72eb4ae799fe99d49cb49b0f5721cbfac0e3</citedby><cites>FETCH-LOGICAL-c415t-1fb96b9cf0041b21167b33baffe4c72eb4ae799fe99d49cb49b0f5721cbfac0e3</cites><orcidid>0000-0002-7423-0111</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29955836$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Curran, Desmond</creatorcontrib><creatorcontrib>Oostvogels, Lidia</creatorcontrib><creatorcontrib>Heineman, Thomas</creatorcontrib><creatorcontrib>Matthews, Sean</creatorcontrib><creatorcontrib>McElhaney, Janet</creatorcontrib><creatorcontrib>McNeil, Shelly</creatorcontrib><creatorcontrib>Diez-Domingo, Javier</creatorcontrib><creatorcontrib>Lal, Himal</creatorcontrib><creatorcontrib>Andrews, Charles</creatorcontrib><creatorcontrib>Athan, Eugene</creatorcontrib><creatorcontrib>Berglund, Johan</creatorcontrib><creatorcontrib>Campora, Laura</creatorcontrib><creatorcontrib>de Looze, Ferdinandus</creatorcontrib><creatorcontrib>Korhonen, Tiina</creatorcontrib><creatorcontrib>Leung, Edward</creatorcontrib><creatorcontrib>Levin, Myron</creatorcontrib><creatorcontrib>Volpi, Antonio</creatorcontrib><creatorcontrib>Johnson, Robert W</creatorcontrib><creatorcontrib>ZOE-50/70 Study Group</creatorcontrib><title>Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older</title><title>The journals of gerontology. Series A, Biological sciences and medical sciences</title><addtitle>J Gerontol A Biol Sci Med Sci</addtitle><description>To determine the efficacy of an adjuvanted recombinant zoster vaccine in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living, and HZ impact on quality of life.
The assessments were integrated in two Phase III trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). HZ burden of illness and HZ burden of interference with activities of daily living were assessed by the Zoster Brief Pain Inventory (ZBPI) instrument and quality of life by the EuroQol-5 Dimension (EQ-5D) utility index and the SF-36 health survey. We report the ZOE-50 results and a pooled analysis of patients aged 70 years and older from the trials combined.
The estimated vaccine efficacy in reducing HZ burden of illness and HZ burden of interference was greater than 90% in both the ZOE-50 and the pooled ZOE-70 analysis. In confirmed HZ cases, adjuvanted recombinant zoster vaccine reduced the maximal ZBPI worst-pain score in the pooled ZOE-70 analysis (p = .032) and the maximal ZBPI average-pain scores in both the ZOE-50 (p = .049) and the pooled ZOE-70 analysis (p = .043). In breakthrough HZ cases, trends for diminished loss of quality of life compared with placebo-recipient HZ cases were observed, with differences up to 0.14 on the EQ-5D index at time points during the 4 weeks following HZ onset.
Adjuvanted recombinant zoster vaccine reduced the HZ burden of illness significantly, particularly due to its very high vaccine efficacy in preventing HZ. For breakthrough HZ cases, the results suggest that the adjuvanted recombinant zoster vaccine mitigated severity of HZ-related pain, burden of interference with activities of daily living, and recipients' utility loss.</description><subject>Activities of daily living</subject><subject>Adjuvants</subject><subject>Clinical trials</subject><subject>Combined vaccines</subject><subject>Herpes viruses</subject><subject>Herpes zoster</subject><subject>Pain</subject><subject>Quality of life</subject><subject>The Journal of Gerontology: Translational Section</subject><subject>Vaccine efficacy</subject><subject>Vaccines</subject><issn>1079-5006</issn><issn>1758-535X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNpdkctr3DAQxkVpaV499hoEveTiRg_LXl0KS8gLFkJDUppchCSPNlpsaSPZgf3vo2XT0HYuMx_z42OGD6GvlHynRPLTJaQY9Omy31BBPqB92opZJbj4_bHMpJWVIKTZQwc5r8i2BPuM9piUQsx4s4-6n5Pu_bjB0eGFd4Cvh7W241bqgOfdanrRYYQO34KNg_GhKPwY8wgJ_9LW-gDYb8GpHzOeLwspCH4AnXIx6PBN30E6Qp-c7jN8eeuH6P7i_O7sqlrcXF6fzReVrakYK-qMbIy0jpCaGkZp0xrOjXYOatsyMLWGVkoHUna1tKaWhjjRMmqN05YAP0Q_dr7ryQzQWQhj0r1aJz_otFFRe_XvJvgntYwvqmmYEJIUg5M3gxSfJ8ijGny20Pc6QJyyYqRhM85rJgr67T90FacUynuKsVZIOuOiLVS1o2yKOSdw78dQorb5qV1-apdf4Y___uCd_hMYfwVgwplr</recordid><startdate>20190712</startdate><enddate>20190712</enddate><creator>Curran, Desmond</creator><creator>Oostvogels, Lidia</creator><creator>Heineman, Thomas</creator><creator>Matthews, Sean</creator><creator>McElhaney, Janet</creator><creator>McNeil, Shelly</creator><creator>Diez-Domingo, Javier</creator><creator>Lal, Himal</creator><creator>Andrews, Charles</creator><creator>Athan, Eugene</creator><creator>Berglund, Johan</creator><creator>Campora, Laura</creator><creator>de Looze, Ferdinandus</creator><creator>Korhonen, Tiina</creator><creator>Leung, Edward</creator><creator>Levin, Myron</creator><creator>Volpi, Antonio</creator><creator>Johnson, Robert W</creator><general>Oxford University Press</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-7423-0111</orcidid></search><sort><creationdate>20190712</creationdate><title>Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older</title><author>Curran, Desmond ; Oostvogels, Lidia ; Heineman, Thomas ; Matthews, Sean ; McElhaney, Janet ; McNeil, Shelly ; Diez-Domingo, Javier ; Lal, Himal ; Andrews, Charles ; Athan, Eugene ; Berglund, Johan ; Campora, Laura ; de Looze, Ferdinandus ; Korhonen, Tiina ; Leung, Edward ; Levin, Myron ; Volpi, Antonio ; Johnson, Robert W</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c415t-1fb96b9cf0041b21167b33baffe4c72eb4ae799fe99d49cb49b0f5721cbfac0e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Activities of daily living</topic><topic>Adjuvants</topic><topic>Clinical trials</topic><topic>Combined vaccines</topic><topic>Herpes viruses</topic><topic>Herpes zoster</topic><topic>Pain</topic><topic>Quality of life</topic><topic>The Journal of Gerontology: Translational Section</topic><topic>Vaccine efficacy</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Curran, Desmond</creatorcontrib><creatorcontrib>Oostvogels, Lidia</creatorcontrib><creatorcontrib>Heineman, Thomas</creatorcontrib><creatorcontrib>Matthews, Sean</creatorcontrib><creatorcontrib>McElhaney, Janet</creatorcontrib><creatorcontrib>McNeil, Shelly</creatorcontrib><creatorcontrib>Diez-Domingo, Javier</creatorcontrib><creatorcontrib>Lal, Himal</creatorcontrib><creatorcontrib>Andrews, Charles</creatorcontrib><creatorcontrib>Athan, Eugene</creatorcontrib><creatorcontrib>Berglund, Johan</creatorcontrib><creatorcontrib>Campora, Laura</creatorcontrib><creatorcontrib>de Looze, Ferdinandus</creatorcontrib><creatorcontrib>Korhonen, Tiina</creatorcontrib><creatorcontrib>Leung, Edward</creatorcontrib><creatorcontrib>Levin, Myron</creatorcontrib><creatorcontrib>Volpi, Antonio</creatorcontrib><creatorcontrib>Johnson, Robert W</creatorcontrib><creatorcontrib>ZOE-50/70 Study Group</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The journals of gerontology. Series A, Biological sciences and medical sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Curran, Desmond</au><au>Oostvogels, Lidia</au><au>Heineman, Thomas</au><au>Matthews, Sean</au><au>McElhaney, Janet</au><au>McNeil, Shelly</au><au>Diez-Domingo, Javier</au><au>Lal, Himal</au><au>Andrews, Charles</au><au>Athan, Eugene</au><au>Berglund, Johan</au><au>Campora, Laura</au><au>de Looze, Ferdinandus</au><au>Korhonen, Tiina</au><au>Leung, Edward</au><au>Levin, Myron</au><au>Volpi, Antonio</au><au>Johnson, Robert W</au><aucorp>ZOE-50/70 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older</atitle><jtitle>The journals of gerontology. Series A, Biological sciences and medical sciences</jtitle><addtitle>J Gerontol A Biol Sci Med Sci</addtitle><date>2019-07-12</date><risdate>2019</risdate><volume>74</volume><issue>8</issue><spage>1231</spage><epage>1238</epage><pages>1231-1238</pages><issn>1079-5006</issn><eissn>1758-535X</eissn><abstract>To determine the efficacy of an adjuvanted recombinant zoster vaccine in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living, and HZ impact on quality of life.
The assessments were integrated in two Phase III trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). HZ burden of illness and HZ burden of interference with activities of daily living were assessed by the Zoster Brief Pain Inventory (ZBPI) instrument and quality of life by the EuroQol-5 Dimension (EQ-5D) utility index and the SF-36 health survey. We report the ZOE-50 results and a pooled analysis of patients aged 70 years and older from the trials combined.
The estimated vaccine efficacy in reducing HZ burden of illness and HZ burden of interference was greater than 90% in both the ZOE-50 and the pooled ZOE-70 analysis. In confirmed HZ cases, adjuvanted recombinant zoster vaccine reduced the maximal ZBPI worst-pain score in the pooled ZOE-70 analysis (p = .032) and the maximal ZBPI average-pain scores in both the ZOE-50 (p = .049) and the pooled ZOE-70 analysis (p = .043). In breakthrough HZ cases, trends for diminished loss of quality of life compared with placebo-recipient HZ cases were observed, with differences up to 0.14 on the EQ-5D index at time points during the 4 weeks following HZ onset.
Adjuvanted recombinant zoster vaccine reduced the HZ burden of illness significantly, particularly due to its very high vaccine efficacy in preventing HZ. For breakthrough HZ cases, the results suggest that the adjuvanted recombinant zoster vaccine mitigated severity of HZ-related pain, burden of interference with activities of daily living, and recipients' utility loss.</abstract><cop>United States</cop><pub>Oxford University Press</pub><pmid>29955836</pmid><doi>10.1093/gerona/gly150</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-7423-0111</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| subjects | Activities of daily living Adjuvants Clinical trials Combined vaccines Herpes viruses Herpes zoster Pain Quality of life The Journal of Gerontology: Translational Section Vaccine efficacy Vaccines |
| title | Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older |
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