Immunogenicity of High Dose Influenza Vaccine for Patients with Inflammatory Bowel Disease on Anti-TNF Monotherapy: A Randomized Clinical Trial
BackgroundPatients with inflammatory bowel disease (IBD) on anti-tumor necrosis factor alpha (TNF) agents may have lower immune response to the influenza vaccine. We aimed to evaluate the immunogenicity of the high dose (HD) vs standard dose (SD) influenza vaccine in patients with IBD on anti-TNF mo...
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Veröffentlicht in: | Inflammatory bowel diseases 2020-03, Vol.26 (4), p.593-602 |
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description | BackgroundPatients with inflammatory bowel disease (IBD) on anti-tumor necrosis factor alpha (TNF) agents may have lower immune response to the influenza vaccine. We aimed to evaluate the immunogenicity of the high dose (HD) vs standard dose (SD) influenza vaccine in patients with IBD on anti-TNF monotherapy.MethodsWe performed a randomized clinical trial at a single academic center evaluating the immunogenicity of the HD vs SD influenza vaccine in patients with IBD on anti-TNF monotherapy. Influenza antibody concentration was measured at immunization, at 2 to 4 weeks postimmunization, and at 6 months.ResultsSixty-nine patients with IBD were recruited into the study, 40 on anti-TNF monotherapy, and 19 on vedolizumab, along with 20 healthy controls (HC). Patients with IBD receiving the HD influenza vaccine had significantly higher H3N2 postimmunization antibodies compared with those who received the SD influenza vaccine (160 [interquartile range 80 to 320] vs 80 [interquartile range 40 to 160]; P = 0.003). The H1N1 postimmunization levels were not significantly higher in the HD influenza vaccine (320 [interquartile range 150 to 320] vs 160 [interquartile range 80 to 320]; P = 0.18). Patients with IBD receiving the HD influenza vaccine and those on vedolizumab who received SD had equivalent antibody concentrations to HC (H1N1 P = 0.85; H3N2 P = 0.23; B/Victoria P = 0.20 and H1N1 P = 0.46; H3N2 P = 0.21; B/Victoria P = 1.00, respectively).ConclusionsPatients with IBD on anti-TNF monotherapy receiving the HD influenza vaccine had significantly higher postimmunization antibody levels compared with SD vaccine. Clinicaltrials.gov (#NCT02461758).High-dose influenza vaccine improves immunogenicity compared with standard-dose vaccine in patients with IBD on anti-TNF therapy and may provide better protection against infection. Vedolizumab does not impact immune response to influenza vaccine in patients with IBD.Video Abstract
10.1093/ibd/izz164_video1Video Abstractizz164_video16076481126001 |
doi_str_mv | 10.1093/ibd/izz164 |
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10.1093/ibd/izz164_video1Video Abstractizz164_video16076481126001</description><identifier>ISSN: 1078-0998</identifier><identifier>EISSN: 1536-4844</identifier><identifier>DOI: 10.1093/ibd/izz164</identifier><identifier>PMID: 31504526</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Adalimumab ; Adult ; Antibodies, Monoclonal, Humanized ; Antibodies, Viral - blood ; Clinical trials ; Female ; Gastrointestinal diseases ; Hemagglutination Inhibition Tests ; High-definition television ; Humans ; Immune response ; Immunogenicity, Vaccine ; Immunosuppressive agents ; Inflammatory Bowel Diseases - drug therapy ; Inflammatory Bowel Diseases - immunology ; Inflammatory Bowel Diseases - virology ; Influenza ; Influenza A Virus, H1N1 Subtype ; Influenza A Virus, H3N2 Subtype ; Influenza B virus ; Influenza vaccines ; Influenza Vaccines - administration & dosage ; Influenza Vaccines - immunology ; Influenza, Human - immunology ; Influenza, Human - prevention & control ; Male ; Middle Aged ; Tumor necrosis factor ; Tumor Necrosis Factor Inhibitors - therapeutic use ; Vaccination</subject><ispartof>Inflammatory bowel diseases, 2020-03, Vol.26 (4), p.593-602</ispartof><rights>2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. 2019</rights><rights>2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><rights>COPYRIGHT 2020 Oxford University Press</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c345t-c9d16214a654bd6705e8056141c3a02b384b6a582cf0f881cfc258722825c81e3</citedby><cites>FETCH-LOGICAL-c345t-c9d16214a654bd6705e8056141c3a02b384b6a582cf0f881cfc258722825c81e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,1578,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31504526$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Caldera, Freddy</creatorcontrib><creatorcontrib>Hillman, Luke</creatorcontrib><creatorcontrib>Saha, Sumona</creatorcontrib><creatorcontrib>Wald, Arnold</creatorcontrib><creatorcontrib>Grimes, Ian</creatorcontrib><creatorcontrib>Zhang, Youqi</creatorcontrib><creatorcontrib>Sharpe, Abigail R</creatorcontrib><creatorcontrib>Reichelderfer, Mark</creatorcontrib><creatorcontrib>Hayney, Mary S</creatorcontrib><title>Immunogenicity of High Dose Influenza Vaccine for Patients with Inflammatory Bowel Disease on Anti-TNF Monotherapy: A Randomized Clinical Trial</title><title>Inflammatory bowel diseases</title><addtitle>Inflamm Bowel Dis</addtitle><description>BackgroundPatients with inflammatory bowel disease (IBD) on anti-tumor necrosis factor alpha (TNF) agents may have lower immune response to the influenza vaccine. We aimed to evaluate the immunogenicity of the high dose (HD) vs standard dose (SD) influenza vaccine in patients with IBD on anti-TNF monotherapy.MethodsWe performed a randomized clinical trial at a single academic center evaluating the immunogenicity of the HD vs SD influenza vaccine in patients with IBD on anti-TNF monotherapy. Influenza antibody concentration was measured at immunization, at 2 to 4 weeks postimmunization, and at 6 months.ResultsSixty-nine patients with IBD were recruited into the study, 40 on anti-TNF monotherapy, and 19 on vedolizumab, along with 20 healthy controls (HC). Patients with IBD receiving the HD influenza vaccine had significantly higher H3N2 postimmunization antibodies compared with those who received the SD influenza vaccine (160 [interquartile range 80 to 320] vs 80 [interquartile range 40 to 160]; P = 0.003). The H1N1 postimmunization levels were not significantly higher in the HD influenza vaccine (320 [interquartile range 150 to 320] vs 160 [interquartile range 80 to 320]; P = 0.18). Patients with IBD receiving the HD influenza vaccine and those on vedolizumab who received SD had equivalent antibody concentrations to HC (H1N1 P = 0.85; H3N2 P = 0.23; B/Victoria P = 0.20 and H1N1 P = 0.46; H3N2 P = 0.21; B/Victoria P = 1.00, respectively).ConclusionsPatients with IBD on anti-TNF monotherapy receiving the HD influenza vaccine had significantly higher postimmunization antibody levels compared with SD vaccine. Clinicaltrials.gov (#NCT02461758).High-dose influenza vaccine improves immunogenicity compared with standard-dose vaccine in patients with IBD on anti-TNF therapy and may provide better protection against infection. Vedolizumab does not impact immune response to influenza vaccine in patients with IBD.Video Abstract
10.1093/ibd/izz164_video1Video Abstractizz164_video16076481126001</description><subject>Adalimumab</subject><subject>Adult</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Antibodies, Viral - blood</subject><subject>Clinical trials</subject><subject>Female</subject><subject>Gastrointestinal diseases</subject><subject>Hemagglutination Inhibition Tests</subject><subject>High-definition television</subject><subject>Humans</subject><subject>Immune response</subject><subject>Immunogenicity, Vaccine</subject><subject>Immunosuppressive agents</subject><subject>Inflammatory Bowel Diseases - drug therapy</subject><subject>Inflammatory Bowel Diseases - immunology</subject><subject>Inflammatory Bowel Diseases - virology</subject><subject>Influenza</subject><subject>Influenza A Virus, H1N1 Subtype</subject><subject>Influenza A Virus, H3N2 Subtype</subject><subject>Influenza B virus</subject><subject>Influenza vaccines</subject><subject>Influenza Vaccines - administration & dosage</subject><subject>Influenza Vaccines - immunology</subject><subject>Influenza, Human - immunology</subject><subject>Influenza, Human - prevention & control</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Tumor necrosis factor</subject><subject>Tumor Necrosis Factor Inhibitors - therapeutic use</subject><subject>Vaccination</subject><issn>1078-0998</issn><issn>1536-4844</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp90ctu1DAUBuAIgWgpbHgAZAkhIaS0viZOd8OUtiOVi9DA1nIce8bIsQfbUTXzEn1l3KawRGfhs_j8n8VfVa8RPEWwI2e2H87s4YAa-qQ6Row0NeWUPi07bHkNu44fVS9S-gUhLtM9r44IYpAy3BxXd6txnHzYaG-VzXsQDLi2my24CEmDlTdu0v4gwU-plPUamBDBN5mt9jmBW5u3D0aOo8wh7sHHcKsduLBJy_I9eLDw2dbrL5fgc_Ahb3WUu_05WIDv0g9htAc9gKWz5bZ0YB2tdC-rZ0a6pF89vifVj8tP6-V1ffP1arVc3NSKUJZr1Q2owYjKhtF-aFrINIesQRQpIiHuCad9IxnHykDDOVJGYcZbjDlmiiNNTqr3c-4uht-TTlmMNintnPQ6TEkUWTjhBBf6dqYb6bSw3oQcpbrnYtF0bQtxiS7qw6xUDClFbcQu2lHGvUBQ3NckSk1irqngN4_Xp37Uwz_6t5cC3s0gTLv_Bf0BsHWagw</recordid><startdate>20200304</startdate><enddate>20200304</enddate><creator>Caldera, Freddy</creator><creator>Hillman, Luke</creator><creator>Saha, Sumona</creator><creator>Wald, Arnold</creator><creator>Grimes, Ian</creator><creator>Zhang, Youqi</creator><creator>Sharpe, Abigail R</creator><creator>Reichelderfer, Mark</creator><creator>Hayney, Mary S</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20200304</creationdate><title>Immunogenicity of High Dose Influenza Vaccine for Patients with Inflammatory Bowel Disease on Anti-TNF Monotherapy: A Randomized Clinical Trial</title><author>Caldera, Freddy ; Hillman, Luke ; Saha, Sumona ; Wald, Arnold ; Grimes, Ian ; Zhang, Youqi ; Sharpe, Abigail R ; Reichelderfer, Mark ; Hayney, Mary S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c345t-c9d16214a654bd6705e8056141c3a02b384b6a582cf0f881cfc258722825c81e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adalimumab</topic><topic>Adult</topic><topic>Antibodies, Monoclonal, Humanized</topic><topic>Antibodies, Viral - blood</topic><topic>Clinical trials</topic><topic>Female</topic><topic>Gastrointestinal diseases</topic><topic>Hemagglutination Inhibition Tests</topic><topic>High-definition television</topic><topic>Humans</topic><topic>Immune response</topic><topic>Immunogenicity, Vaccine</topic><topic>Immunosuppressive agents</topic><topic>Inflammatory Bowel Diseases - drug therapy</topic><topic>Inflammatory Bowel Diseases - immunology</topic><topic>Inflammatory Bowel Diseases - virology</topic><topic>Influenza</topic><topic>Influenza A Virus, H1N1 Subtype</topic><topic>Influenza A Virus, H3N2 Subtype</topic><topic>Influenza B virus</topic><topic>Influenza vaccines</topic><topic>Influenza Vaccines - administration & dosage</topic><topic>Influenza Vaccines - immunology</topic><topic>Influenza, Human - immunology</topic><topic>Influenza, Human - prevention & control</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Tumor necrosis factor</topic><topic>Tumor Necrosis Factor Inhibitors - therapeutic use</topic><topic>Vaccination</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Caldera, Freddy</creatorcontrib><creatorcontrib>Hillman, Luke</creatorcontrib><creatorcontrib>Saha, Sumona</creatorcontrib><creatorcontrib>Wald, Arnold</creatorcontrib><creatorcontrib>Grimes, Ian</creatorcontrib><creatorcontrib>Zhang, Youqi</creatorcontrib><creatorcontrib>Sharpe, Abigail R</creatorcontrib><creatorcontrib>Reichelderfer, Mark</creatorcontrib><creatorcontrib>Hayney, Mary S</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Inflammatory bowel diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Caldera, Freddy</au><au>Hillman, Luke</au><au>Saha, Sumona</au><au>Wald, Arnold</au><au>Grimes, Ian</au><au>Zhang, Youqi</au><au>Sharpe, Abigail R</au><au>Reichelderfer, Mark</au><au>Hayney, Mary S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immunogenicity of High Dose Influenza Vaccine for Patients with Inflammatory Bowel Disease on Anti-TNF Monotherapy: A Randomized Clinical Trial</atitle><jtitle>Inflammatory bowel diseases</jtitle><addtitle>Inflamm Bowel Dis</addtitle><date>2020-03-04</date><risdate>2020</risdate><volume>26</volume><issue>4</issue><spage>593</spage><epage>602</epage><pages>593-602</pages><issn>1078-0998</issn><eissn>1536-4844</eissn><abstract>BackgroundPatients with inflammatory bowel disease (IBD) on anti-tumor necrosis factor alpha (TNF) agents may have lower immune response to the influenza vaccine. We aimed to evaluate the immunogenicity of the high dose (HD) vs standard dose (SD) influenza vaccine in patients with IBD on anti-TNF monotherapy.MethodsWe performed a randomized clinical trial at a single academic center evaluating the immunogenicity of the HD vs SD influenza vaccine in patients with IBD on anti-TNF monotherapy. Influenza antibody concentration was measured at immunization, at 2 to 4 weeks postimmunization, and at 6 months.ResultsSixty-nine patients with IBD were recruited into the study, 40 on anti-TNF monotherapy, and 19 on vedolizumab, along with 20 healthy controls (HC). Patients with IBD receiving the HD influenza vaccine had significantly higher H3N2 postimmunization antibodies compared with those who received the SD influenza vaccine (160 [interquartile range 80 to 320] vs 80 [interquartile range 40 to 160]; P = 0.003). The H1N1 postimmunization levels were not significantly higher in the HD influenza vaccine (320 [interquartile range 150 to 320] vs 160 [interquartile range 80 to 320]; P = 0.18). Patients with IBD receiving the HD influenza vaccine and those on vedolizumab who received SD had equivalent antibody concentrations to HC (H1N1 P = 0.85; H3N2 P = 0.23; B/Victoria P = 0.20 and H1N1 P = 0.46; H3N2 P = 0.21; B/Victoria P = 1.00, respectively).ConclusionsPatients with IBD on anti-TNF monotherapy receiving the HD influenza vaccine had significantly higher postimmunization antibody levels compared with SD vaccine. Clinicaltrials.gov (#NCT02461758).High-dose influenza vaccine improves immunogenicity compared with standard-dose vaccine in patients with IBD on anti-TNF therapy and may provide better protection against infection. Vedolizumab does not impact immune response to influenza vaccine in patients with IBD.Video Abstract
10.1093/ibd/izz164_video1Video Abstractizz164_video16076481126001</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>31504526</pmid><doi>10.1093/ibd/izz164</doi><tpages>10</tpages></addata></record> |
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subjects | Adalimumab Adult Antibodies, Monoclonal, Humanized Antibodies, Viral - blood Clinical trials Female Gastrointestinal diseases Hemagglutination Inhibition Tests High-definition television Humans Immune response Immunogenicity, Vaccine Immunosuppressive agents Inflammatory Bowel Diseases - drug therapy Inflammatory Bowel Diseases - immunology Inflammatory Bowel Diseases - virology Influenza Influenza A Virus, H1N1 Subtype Influenza A Virus, H3N2 Subtype Influenza B virus Influenza vaccines Influenza Vaccines - administration & dosage Influenza Vaccines - immunology Influenza, Human - immunology Influenza, Human - prevention & control Male Middle Aged Tumor necrosis factor Tumor Necrosis Factor Inhibitors - therapeutic use Vaccination |
title | Immunogenicity of High Dose Influenza Vaccine for Patients with Inflammatory Bowel Disease on Anti-TNF Monotherapy: A Randomized Clinical Trial |
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