Immunogenicity and safety of an investigational AS02v -adjuvanted hepatitis B vaccine in patients with renal insufficiency who failed to respond or to maintain antibody levels after prior vaccination: Results of two open, randomized, comparative trials
Abstract An investigational AS02v -adjuvanted hepatitis B (HB-AS02) was compared with a licensed conventional recombinant hepatitis B vaccine ( HBVAXPRO ™; Sanofi Pasteur MSD, Lyon, France) in pre-dialysis, peritoneal dialysis and hemodialysis patients aged ≥18 years who had failed either to respond...
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| Veröffentlicht in: | Vaccine 2011-02, Vol.29 (6), p.1159-1166 |
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| creator | Tielemans, Christian L Vlasak, Jiri Kosa, Dezider Billiouw, Jean-Marie Verpooten, Gert A Mezei, Ilona Ryba, Miroslav Peeters, Patrick C Mat, Olivier Jadoul, Michel Y Polakovic, Vladimir Dhaene, Michel Treille, Serge Kuriyakose, Sherine O Leyssen, Maarten Houard, Sophie A Surquin, Murielle |
| description | Abstract An investigational AS02v -adjuvanted hepatitis B (HB-AS02) was compared with a licensed conventional recombinant hepatitis B vaccine ( HBVAXPRO ™; Sanofi Pasteur MSD, Lyon, France) in pre-dialysis, peritoneal dialysis and hemodialysis patients aged ≥18 years who had failed either to respond to prior vaccination with a conventional hepatitis B vaccine (Study A; n = 251) or to maintain protective antibody concentrations after prior hepatitis B vaccination (Study B; n = 181). These were open, randomized, comparative trials. Mean (range) age was 65.9 (31–92) and 64.6 (29–92) years in the two studies, respectively. In Study A, two doses of HB-AS02 given one month apart were found to be superior to two doses of the licensed vaccine in terms of seroprotection rate (76.9% versus 37.6%) and anti-HBs geometric mean antibody concentration (GMC; 139.3 versus 6.9 mIU/ml), with antibody concentrations ≥100 mIU/ml in 61.1% and 15.4% of subjects in the two groups, respectively. In Study B, one month after administration of a single booster dose, seroprotection rates were 89.0% in the HB-AS02 group and 90.8% in the licensed vaccine group, 81.3% and 60.9% of subjects had antibody concentrations ≥100 mIU/ml, and anti-HBs GMCs were 1726.8 and 189.5 mIU/ml. HB-AS02 was found to be more reactogenic than the licensed vaccine. In summary, the investigational HB-AS02 vaccine induced higher seroprotection rates and anti-HBs GMCs than a licensed conventional hepatitis B vaccine in uremic patients who had failed to respond or to maintain protective antibody titers after prior hepatitis B vaccination. |
| doi_str_mv | 10.1016/j.vaccine.2010.12.009 |
| format | Article |
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These were open, randomized, comparative trials. Mean (range) age was 65.9 (31–92) and 64.6 (29–92) years in the two studies, respectively. In Study A, two doses of HB-AS02 given one month apart were found to be superior to two doses of the licensed vaccine in terms of seroprotection rate (76.9% versus 37.6%) and anti-HBs geometric mean antibody concentration (GMC; 139.3 versus 6.9 mIU/ml), with antibody concentrations ≥100 mIU/ml in 61.1% and 15.4% of subjects in the two groups, respectively. In Study B, one month after administration of a single booster dose, seroprotection rates were 89.0% in the HB-AS02 group and 90.8% in the licensed vaccine group, 81.3% and 60.9% of subjects had antibody concentrations ≥100 mIU/ml, and anti-HBs GMCs were 1726.8 and 189.5 mIU/ml. HB-AS02 was found to be more reactogenic than the licensed vaccine. In summary, the investigational HB-AS02 vaccine induced higher seroprotection rates and anti-HBs GMCs than a licensed conventional hepatitis B vaccine in uremic patients who had failed to respond or to maintain protective antibody titers after prior hepatitis B vaccination.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2010.12.009</identifier><identifier>CODEN: VACCDE</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Adjuvant ; Allergy and Immunology ; Applied microbiology ; Biological and medical sciences ; Cardiovascular disease ; Confidence intervals ; Coronary vessels ; Dialysis ; Disease prevention ; Fractures ; Fundamental and applied biological sciences. Psychology ; HB-AS02 ; Heart failure ; hemodialysis ; Hepatitis ; Hepatitis B ; Human viral diseases ; immune response ; Immunogenicity ; Infections ; Infectious diseases ; Licenses ; Medical sciences ; Microbiology ; patients ; Peritoneal dialysis ; renal failure ; Studies ; Thrombosis ; Vaccination ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Viral diseases ; Viral hepatitis</subject><ispartof>Vaccine, 2011-02, Vol.29 (6), p.1159-1166</ispartof><rights>2010</rights><rights>2015 INIST-CNRS</rights><rights>Copyright Elsevier Limited Feb 1, 2011</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c446t-aaf38015fe00ac63db20a42bea0b06519bc48bed84f42fbe65e6bb149c89274c3</citedby><cites>FETCH-LOGICAL-c446t-aaf38015fe00ac63db20a42bea0b06519bc48bed84f42fbe65e6bb149c89274c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1498112557?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>315,782,786,3554,27933,27934,46004,64394,64398,72478</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23860968$$DView record in Pascal Francis$$Hfree_for_read</backlink></links><search><creatorcontrib>Tielemans, Christian L</creatorcontrib><creatorcontrib>Vlasak, Jiri</creatorcontrib><creatorcontrib>Kosa, Dezider</creatorcontrib><creatorcontrib>Billiouw, Jean-Marie</creatorcontrib><creatorcontrib>Verpooten, Gert A</creatorcontrib><creatorcontrib>Mezei, Ilona</creatorcontrib><creatorcontrib>Ryba, Miroslav</creatorcontrib><creatorcontrib>Peeters, Patrick C</creatorcontrib><creatorcontrib>Mat, Olivier</creatorcontrib><creatorcontrib>Jadoul, Michel Y</creatorcontrib><creatorcontrib>Polakovic, Vladimir</creatorcontrib><creatorcontrib>Dhaene, Michel</creatorcontrib><creatorcontrib>Treille, Serge</creatorcontrib><creatorcontrib>Kuriyakose, Sherine O</creatorcontrib><creatorcontrib>Leyssen, Maarten</creatorcontrib><creatorcontrib>Houard, Sophie A</creatorcontrib><creatorcontrib>Surquin, Murielle</creatorcontrib><title>Immunogenicity and safety of an investigational AS02v -adjuvanted hepatitis B vaccine in patients with renal insufficiency who failed to respond or to maintain antibody levels after prior vaccination: Results of two open, randomized, comparative trials</title><title>Vaccine</title><description>Abstract An investigational AS02v -adjuvanted hepatitis B (HB-AS02) was compared with a licensed conventional recombinant hepatitis B vaccine ( HBVAXPRO ™; Sanofi Pasteur MSD, Lyon, France) in pre-dialysis, peritoneal dialysis and hemodialysis patients aged ≥18 years who had failed either to respond to prior vaccination with a conventional hepatitis B vaccine (Study A; n = 251) or to maintain protective antibody concentrations after prior hepatitis B vaccination (Study B; n = 181). These were open, randomized, comparative trials. Mean (range) age was 65.9 (31–92) and 64.6 (29–92) years in the two studies, respectively. In Study A, two doses of HB-AS02 given one month apart were found to be superior to two doses of the licensed vaccine in terms of seroprotection rate (76.9% versus 37.6%) and anti-HBs geometric mean antibody concentration (GMC; 139.3 versus 6.9 mIU/ml), with antibody concentrations ≥100 mIU/ml in 61.1% and 15.4% of subjects in the two groups, respectively. In Study B, one month after administration of a single booster dose, seroprotection rates were 89.0% in the HB-AS02 group and 90.8% in the licensed vaccine group, 81.3% and 60.9% of subjects had antibody concentrations ≥100 mIU/ml, and anti-HBs GMCs were 1726.8 and 189.5 mIU/ml. HB-AS02 was found to be more reactogenic than the licensed vaccine. In summary, the investigational HB-AS02 vaccine induced higher seroprotection rates and anti-HBs GMCs than a licensed conventional hepatitis B vaccine in uremic patients who had failed to respond or to maintain protective antibody titers after prior hepatitis B vaccination.</description><subject>Adjuvant</subject><subject>Allergy and Immunology</subject><subject>Applied microbiology</subject><subject>Biological and medical sciences</subject><subject>Cardiovascular disease</subject><subject>Confidence intervals</subject><subject>Coronary vessels</subject><subject>Dialysis</subject><subject>Disease prevention</subject><subject>Fractures</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>HB-AS02</subject><subject>Heart failure</subject><subject>hemodialysis</subject><subject>Hepatitis</subject><subject>Hepatitis B</subject><subject>Human viral diseases</subject><subject>immune response</subject><subject>Immunogenicity</subject><subject>Infections</subject><subject>Infectious diseases</subject><subject>Licenses</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>patients</subject><subject>Peritoneal dialysis</subject><subject>renal failure</subject><subject>Studies</subject><subject>Thrombosis</subject><subject>Vaccination</subject><subject>Vaccines</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</subject><subject>Viral diseases</subject><subject>Viral hepatitis</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkluL1DAUx4soOK5-BDEgvm3HJL1M64OyLu66sCA4LvgW0vRkJmObdJO0w_jZffB0Z1DwxYeQ2--c8z-XJHnJ6JJRVr7dLSeplLGw5HR-40tK60fJglWrLOUFqx4nC8rLPM0Z_f40eRbCjlJaZKxeJL9u-n60bgPWKBMPRNqWBKkBj07jjRg7QYhmI6NxVnbkYk35RFLZ7sZJ2ggt2cKAn9EE8pGchKAVmR_BxkD2Jm6Jh9nY2DBqjZHAqgPZbx3R0nToIzokwuAwuvPzrZfGRlwoIZrGtQfSwQRdIFJH8GTwBrljtAdl78hXCGOH4VB23DviBrDnxGM-rjc_oT0nyvWD9EhPQKI3sgvPkycaN3hx2s-Su6tP3y4_p7dfrm8uL25TledlTKXUWUVZoYFSqcqsbTiVOW9A0oaWBasblVcNtFWuc64bKAsom4bltapqvspVdpa8PvodvLsfsZxi50aPBQkCqYoxXhQrpIojpbwLwYMWmGUv_UEwKuZGi5041VfMjRaMC2w02r05eZdByU5jzsqEP8Y8q0palxVyr46clk7IjUfmbo2OCkpZhqNSIvHhSGChYTLgRXhoFbTGg4qidea_Wt7_40F1BkdLdj_gAOFv2iKggVjPYzlPJUMNq3xFs98J3uaj</recordid><startdate>20110201</startdate><enddate>20110201</enddate><creator>Tielemans, Christian L</creator><creator>Vlasak, Jiri</creator><creator>Kosa, Dezider</creator><creator>Billiouw, Jean-Marie</creator><creator>Verpooten, Gert A</creator><creator>Mezei, Ilona</creator><creator>Ryba, Miroslav</creator><creator>Peeters, Patrick C</creator><creator>Mat, Olivier</creator><creator>Jadoul, Michel Y</creator><creator>Polakovic, Vladimir</creator><creator>Dhaene, Michel</creator><creator>Treille, Serge</creator><creator>Kuriyakose, Sherine O</creator><creator>Leyssen, Maarten</creator><creator>Houard, Sophie A</creator><creator>Surquin, Murielle</creator><general>Elsevier Ltd</general><general>Elsevier</general><general>Elsevier Limited</general><scope>FBQ</scope><scope>IQODW</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7RV</scope><scope>7T2</scope><scope>7T5</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope></search><sort><creationdate>20110201</creationdate><title>Immunogenicity and safety of an investigational AS02v -adjuvanted hepatitis B vaccine in patients with renal insufficiency who failed to respond or to maintain antibody levels after prior vaccination: Results of two open, randomized, comparative trials</title><author>Tielemans, Christian L ; Vlasak, Jiri ; Kosa, Dezider ; Billiouw, Jean-Marie ; Verpooten, Gert A ; Mezei, Ilona ; Ryba, Miroslav ; Peeters, Patrick C ; Mat, Olivier ; Jadoul, Michel Y ; Polakovic, Vladimir ; Dhaene, Michel ; Treille, Serge ; Kuriyakose, Sherine O ; Leyssen, Maarten ; Houard, Sophie A ; Surquin, Murielle</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c446t-aaf38015fe00ac63db20a42bea0b06519bc48bed84f42fbe65e6bb149c89274c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adjuvant</topic><topic>Allergy and Immunology</topic><topic>Applied microbiology</topic><topic>Biological and medical sciences</topic><topic>Cardiovascular disease</topic><topic>Confidence intervals</topic><topic>Coronary vessels</topic><topic>Dialysis</topic><topic>Disease prevention</topic><topic>Fractures</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>HB-AS02</topic><topic>Heart failure</topic><topic>hemodialysis</topic><topic>Hepatitis</topic><topic>Hepatitis B</topic><topic>Human viral diseases</topic><topic>immune response</topic><topic>Immunogenicity</topic><topic>Infections</topic><topic>Infectious diseases</topic><topic>Licenses</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>patients</topic><topic>Peritoneal dialysis</topic><topic>renal failure</topic><topic>Studies</topic><topic>Thrombosis</topic><topic>Vaccination</topic><topic>Vaccines</topic><topic>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</topic><topic>Viral diseases</topic><topic>Viral hepatitis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tielemans, Christian L</creatorcontrib><creatorcontrib>Vlasak, Jiri</creatorcontrib><creatorcontrib>Kosa, Dezider</creatorcontrib><creatorcontrib>Billiouw, 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Ilona</au><au>Ryba, Miroslav</au><au>Peeters, Patrick C</au><au>Mat, Olivier</au><au>Jadoul, Michel Y</au><au>Polakovic, Vladimir</au><au>Dhaene, Michel</au><au>Treille, Serge</au><au>Kuriyakose, Sherine O</au><au>Leyssen, Maarten</au><au>Houard, Sophie A</au><au>Surquin, Murielle</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immunogenicity and safety of an investigational AS02v -adjuvanted hepatitis B vaccine in patients with renal insufficiency who failed to respond or to maintain antibody levels after prior vaccination: Results of two open, randomized, comparative trials</atitle><jtitle>Vaccine</jtitle><date>2011-02-01</date><risdate>2011</risdate><volume>29</volume><issue>6</issue><spage>1159</spage><epage>1166</epage><pages>1159-1166</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><coden>VACCDE</coden><abstract>Abstract An investigational AS02v -adjuvanted hepatitis B (HB-AS02) was compared with a licensed conventional recombinant hepatitis B vaccine ( HBVAXPRO ™; Sanofi Pasteur MSD, Lyon, France) in pre-dialysis, peritoneal dialysis and hemodialysis patients aged ≥18 years who had failed either to respond to prior vaccination with a conventional hepatitis B vaccine (Study A; n = 251) or to maintain protective antibody concentrations after prior hepatitis B vaccination (Study B; n = 181). These were open, randomized, comparative trials. Mean (range) age was 65.9 (31–92) and 64.6 (29–92) years in the two studies, respectively. In Study A, two doses of HB-AS02 given one month apart were found to be superior to two doses of the licensed vaccine in terms of seroprotection rate (76.9% versus 37.6%) and anti-HBs geometric mean antibody concentration (GMC; 139.3 versus 6.9 mIU/ml), with antibody concentrations ≥100 mIU/ml in 61.1% and 15.4% of subjects in the two groups, respectively. In Study B, one month after administration of a single booster dose, seroprotection rates were 89.0% in the HB-AS02 group and 90.8% in the licensed vaccine group, 81.3% and 60.9% of subjects had antibody concentrations ≥100 mIU/ml, and anti-HBs GMCs were 1726.8 and 189.5 mIU/ml. HB-AS02 was found to be more reactogenic than the licensed vaccine. In summary, the investigational HB-AS02 vaccine induced higher seroprotection rates and anti-HBs GMCs than a licensed conventional hepatitis B vaccine in uremic patients who had failed to respond or to maintain protective antibody titers after prior hepatitis B vaccination.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><doi>10.1016/j.vaccine.2010.12.009</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Vaccine, 2011-02, Vol.29 (6), p.1159-1166 |
| issn | 0264-410X 1873-2518 |
| language | eng |
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| source | Access via ScienceDirect (Elsevier); ProQuest Central UK/Ireland |
| subjects | Adjuvant Allergy and Immunology Applied microbiology Biological and medical sciences Cardiovascular disease Confidence intervals Coronary vessels Dialysis Disease prevention Fractures Fundamental and applied biological sciences. Psychology HB-AS02 Heart failure hemodialysis Hepatitis Hepatitis B Human viral diseases immune response Immunogenicity Infections Infectious diseases Licenses Medical sciences Microbiology patients Peritoneal dialysis renal failure Studies Thrombosis Vaccination Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Viral diseases Viral hepatitis |
| title | Immunogenicity and safety of an investigational AS02v -adjuvanted hepatitis B vaccine in patients with renal insufficiency who failed to respond or to maintain antibody levels after prior vaccination: Results of two open, randomized, comparative trials |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-11-30T21%3A55%3A56IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Immunogenicity%20and%20safety%20of%20an%20investigational%20AS02v%20-adjuvanted%20hepatitis%20B%20vaccine%20in%20patients%20with%20renal%20insufficiency%20who%20failed%20to%20respond%20or%20to%20maintain%20antibody%20levels%20after%20prior%20vaccination:%20Results%20of%20two%20open,%20randomized,%20comparative%20trials&rft.jtitle=Vaccine&rft.au=Tielemans,%20Christian%20L&rft.date=2011-02-01&rft.volume=29&rft.issue=6&rft.spage=1159&rft.epage=1166&rft.pages=1159-1166&rft.issn=0264-410X&rft.eissn=1873-2518&rft.coden=VACCDE&rft_id=info:doi/10.1016/j.vaccine.2010.12.009&rft_dat=%3Cproquest_cross%3E3218582201%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1498112557&rft_id=info:pmid/&rft_els_id=S0264410X10017470&rfr_iscdi=true |