{"id":14151,"date":"2019-06-17T15:31:22","date_gmt":"2019-06-17T13:31:22","guid":{"rendered":"https:\/\/www.hollandbio.nl\/?p=14151"},"modified":"2019-06-18T15:34:24","modified_gmt":"2019-06-18T13:34:24","slug":"phase-2-trial-shows-efficacy-of-cytuvaxs-adjuvant-platform-technology","status":"publish","type":"post","link":"https:\/\/www.hollandbio.nl\/en\/nieuws\/phase-2-trial-shows-efficacy-of-cytuvaxs-adjuvant-platform-technology\/","title":{"rendered":"Phase 2 Trial Shows Efficacy of CyTuVax\u2019s Adjuvant Platform Technology"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">CyTuVax has released the results of the HBAI20 Phase 2 \u201c<em>BE-Responder\u201d<\/em> trial<em>. <\/em>This trial focused on so-called non-responders to hepatitis B vaccination, persons who have been vaccinated with at least one complete vaccination course (3 injections of a licensed hepatitis B vaccine) without achieving a protective immune response.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In this study population of\nhepatitis B vaccine non-responders, the HBAI20 vaccine is able to reduce the\npercentage of non-responders to 8% compared to 21% in the HBVaxPro-10 group (<em>p<\/em> = .068 Fisher). Statistical\nevaluation using a generalized linear mixed model demonstrates that subjects\nwho have received the HBAI20 vaccine are 3.5 times more likely to attain\nseroprotection at the end of the study compared with subjects who received the\nlicensed HBVaxPro-10 vaccine (<em>p<\/em> &lt; .05). <br>\nWith the HBAI20 vaccine, seroprotection was achieved earlier than with the\nHBVAxPro-10 vaccine. 83% of the non-responders attained seroprotection after\nonly 2 vaccinations. In contrast, with the licensed HBVaxPro-10 vaccine, even\nafter 3 injections only 79% of the non-responders achieved seroprotection.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The safety profile of\nHBAI20, as compared to HBVaxPro-10, showed a temporary higher number of\ntransient mild and moderate local side effects: impaired arm movement, redness,\nand pain at injection site indicating that HBAI20 induces a stronger immune\nresponse. No differences regarding systemic side effects were observed.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The \u201c<em>BE-Responder\u201d<\/em> study was a double-blind randomized\ncontrolled phase 2 clinical trial, and enrolled 133 adults subjects in 2 arms\nwith a ratio of 3:1 (HBAI20 : HBVaxPro-10). Subjects were recruited at 3 sites:\nMUMC (Maastricht), ZOL\/UH (Genk), and VAXINFECTIO (Antwerp). Both vaccines were\nadministered 3 times in a 0, 1, and 2 months schedule. CyTuVax adjuvant for the\nHBAI20 vaccine consisted 20 \u00b5g of depot-formulated Interleukin-2 aggregates.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Source: <a rel=\"noreferrer noopener\" href=\"http:\/\/www.cytuvax.com\/\" target=\"_blank\">CyTuVax <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CyTuVax has released the results of the HBAI20 Phase 2 \u201cBE-Responder\u201d trial. This trial focused on so-called non-responders to hepatitis B vaccination, persons who have been vaccinated with at least one complete vaccination course (3 injections of a licensed hepatitis B vaccine) without achieving a protective immune response. In this study population of hepatitis B [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[],"class_list":["post-14151","post","type-post","status-publish","format-standard","hentry","category-gezondheid"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Phase 2 Trial Shows Efficacy of CyTuVax\u2019s Adjuvant Platform Technology - hollandbio<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.hollandbio.nl\/en\/nieuws\/phase-2-trial-shows-efficacy-of-cytuvaxs-adjuvant-platform-technology\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Phase 2 Trial Shows Efficacy of CyTuVax\u2019s Adjuvant Platform Technology - hollandbio\" \/>\n<meta property=\"og:description\" content=\"CyTuVax has released the results of the HBAI20 Phase 2 \u201cBE-Responder\u201d trial. This trial focused on so-called non-responders to hepatitis B vaccination, persons who have been vaccinated with at least one complete vaccination course (3 injections of a licensed hepatitis B vaccine) without achieving a protective immune response. 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