{"id":3575,"date":"2025-05-09T12:55:08","date_gmt":"2025-05-09T15:55:08","guid":{"rendered":"https:\/\/desertkingdev.wpenginepowered.com\/leroux-roels-i-et-al-safety-and-immunogenicity-of-an-adjuvanted-clostridioides-difficile-vaccine-candidate-in-healthy-adults-a-randomized-placebo-controlled-phase-1-study\/"},"modified":"2025-05-09T12:55:08","modified_gmt":"2025-05-09T15:55:08","slug":"leroux-roels-i-et-al-safety-and-immunogenicity-of-an-adjuvanted-clostridioides-difficile-vaccine-candidate-in-healthy-adults-a-randomized-placebo-controlled-phase-1-study","status":"publish","type":"post","link":"https:\/\/desertking.com\/es\/leroux-roels-i-et-al-safety-and-immunogenicity-of-an-adjuvanted-clostridioides-difficile-vaccine-candidate-in-healthy-adults-a-randomized-placebo-controlled-phase-1-study\/","title":{"rendered":"Leroux-Roels, I., et al. Safety and Immunogenicity of an Adjuvanted Clostridioides difficile Vaccine Candidate in Healthy Adults: A Randomized Placebo-Controlled Phase 1 Study."},"content":{"rendered":"<p><strong><span class=\"TextRun SCXW131514829 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW131514829 BCX0\">Leroux-<\/span><span class=\"NormalTextRun SCXW131514829 BCX0\">Roels<\/span><span class=\"NormalTextRun SCXW131514829 BCX0\">,<\/span><span class=\"NormalTextRun SCXW131514829 BCX0\"> I<\/span><span class=\"NormalTextRun SCXW131514829 BCX0\">.<\/span><span class=\"NormalTextRun SCXW131514829 BCX0\">,<\/span><span class=\"NormalTextRun SCXW131514829 BCX0\"> et al. <\/span><span class=\"NormalTextRun SCXW131514829 BCX0\">Safety and Immunogenicity of an Adjuvanted <\/span><\/span><span class=\"TextRun SCXW131514829 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SpellingErrorV2Themed SCXW131514829 BCX0\">Clostridioides<\/span><span class=\"NormalTextRun SCXW131514829 BCX0\"> difficile<\/span><\/span><span class=\"TextRun SCXW131514829 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW131514829 BCX0\"> Vaccine Candidate in Healthy Adults: A Randomized Placebo-Controlled Phase 1 Study.<\/span><\/span><\/strong><\/p>\n<p><strong><span class=\"TextRun SCXW131514829 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW131514829 BCX0\">J Infect Dis<\/span><\/span><span class=\"TextRun SCXW131514829 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW131514829 BCX0\">,<\/span><span class=\"NormalTextRun SCXW131514829 BCX0\"> 2025 Mar 17<\/span><span class=\"NormalTextRun SCXW131514829 BCX0\">, <\/span><span class=\"NormalTextRun SCXW131514829 BCX0\">231(3<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW131514829 BCX0\">):e<\/span><span class=\"NormalTextRun SCXW131514829 BCX0\">511-e520. PMID: 39447053<\/span><\/span><\/strong><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">The study investigated the safety and immunogenicity of GSK\u2019s <\/span><i><span data-contrast=\"auto\">Clostridioides difficile<\/span><\/i><span data-contrast=\"auto\"> vaccine candidate, known as GSK2904545A, in healthy adults aged 18-70. Participants received F2 antigen with or without the AS01 adjuvant in a randomized, placebo-controlled, phase 1 trial.\u00a0<\/span><span data-ccp-props=\"{&quot;134233279&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559685&quot;:720,&quot;335559739&quot;:120,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Immunogenicity: Subjects receiving the F2 antigen combined with the AS01 adjuvant exhibited significantly higher neutralization titers against the <\/span><i><span data-contrast=\"auto\">Clostridioides difficile<\/span><\/i><span data-contrast=\"auto\"> toxins TcdA and TcdB compared to those receiving the F2 antigen alone. Neutralization titers peaked after the second dose but declined before the third dose, after which a substantial increase in titers was observed, particularly in subjects with baseline neutralization titers below the lower limit of quantitation (LLOQ). The third dose notably enhanced the immune response in these participants, highlighting the potential of the vaccine candidate to elicit a robust immune response against <\/span><i><span data-contrast=\"auto\">C. difficile<\/span><\/i><span data-contrast=\"auto\"> infection.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559685&quot;:720,&quot;335559739&quot;:120,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Safety profile: Overall, the vaccine demonstrated a favorable safety profile with no significant safety concerns raised during the study. Most reported adverse events were mild to moderate in severity and were transient, with the most common AEs being injection site pain, fatigue, and headaches. No serious adverse events were deemed related to the vaccine.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559685&quot;:720,&quot;335559739&quot;:120,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">The adjuvant AS01, particularly its saponin component, is crucial for maximizing the effectiveness of the vaccine candidate by enhancing the immune response while also contributing to the overall reactogenicity. Overall, the study suggests that the F2 antigen vaccine candidate is promising for preventing <\/span><i><span data-contrast=\"auto\">C. difficile<\/span><\/i><span data-contrast=\"auto\"> infections, particularly when combined with AS01.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559685&quot;:720,&quot;335559739&quot;:120,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span class=\"TextRun SCXW110005815 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW110005815 BCX0\">Click\u00a0<\/span><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/39447053\/\" target=\"_blank\" rel=\"noopener nofollow\"><span class=\"NormalTextRun SCXW110005815 BCX0\">here\u00a0<\/span><\/a><span class=\"NormalTextRun SCXW110005815 BCX0\">to access the full scientific paper.<\/span><\/span><span class=\"EOP SCXW110005815 BCX0\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:120,&quot;335559740&quot;:240}\">\u00a0<\/p>\n<p>&nbsp;<\/p>\n\t\t\t<style>\r\n\t\t\t\t#sfba_subscribe_form_657 .subscribeform1 {\r\n\t\t\t\t\twidth: 514px;\r\n\t\t\t\t\tborder: 0px groove rgba(159,51,221,0);\r\n\t\t\t\t\tfont-family: 'Verdana';\r\n\t\t\t\t\tbackground-color: #759e2c;\r\n\t\t\t\t\tbackground-image: url('');\r\n\t\t\t\t}\r\n\t\t\t\t#sfba_subscribe_form_657 #sfba-main-form-container.subscribeform1 .sfba-form-sub-heading {\r\n\t\t\t\t\tcolor: #000000;\r\n\t\t\t\t}\r\n\t\t\t\t#sfba_subscribe_form_657 #sfba-main-form-container.subscribeform1 .sfba-form-privacy-heading {\r\n\t\t\t\t\tcolor: ;\r\n\t\t\t\t}\r\n\t\t\t\t#sfba_subscribe_form_657 #sfba-main-form-container.subscribeform1 .sfba-form-heading {\r\n\t\t\t\t\tcolor: #ffffff;\r\n\t\t\t\t}\r\n\t\t\t\t#sfba_subscribe_form_657 .subscribeform1 .sfba_subscribe_form__fields .sfba-form-fields {\r\n\t\t\t\t\tborder-color: rgba(0,0,0,0);\r\n\t\t\t\t}\r\n\t\t\t\t#sfba_subscribe_form_657 .subscribeform1 .sfba-form-consent-fields-main label,\r\n\t\t\t\t#sfba_subscribe_form_657 .subscribeform1 .sfba-form-consent-fields-main {\r\n\t\t\t\t\tcolor: #ffffff;\r\n\t\t\t\t}\r\n\t\t\t\t#sfba_subscribe_form_657 .subscribeform1 #sfba-form-button {\r\n\t\t\t\t\tbackground-color: #4c6938;\r\n\t\t\t\t\tcolor: #ffffff;\r\n\t\t\t\t\tfont-size: 14px;\r\n\t\t\t\t}\r\n\t\t\t\t.subscribeform6 #sfba-form-button {\r\n\t\t\t\t\tbackground-image: url(https:\/\/desertking.com\/wp-content\/plugins\/wp-subscribe-forms-pro\/includes\/..\/images\/sent.png);\r\n\t\t\t\t}\r\n\t\t\t\tinput.sfba-form-fields::placeholder { \/ Chrome, Firefox, Opera, Safari 10.1+ \/\r\n\t\t\t\t  color: #7E7E7E;\r\n\t\t\t\t  opacity: 1; 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Safety and Immunogenicity of an Adjuvanted Clostridioides difficile Vaccine Candidate in Healthy Adults: A Randomized Placebo-Controlled Phase 1 Study. J Infect Dis, 2025 Mar 17, 231(3):e511-e520. PMID: 39447053 The study investigated the safety and immunogenicity of GSK\u2019s Clostridioides difficile vaccine candidate, known as GSK2904545A, in healthy adults aged 18-70. Participants received [&hellip;]<\/p>\n","protected":false},"author":16,"featured_media":3511,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"rs_blank_template":"","rs_page_bg_color":"","slide_template_v7":"","footnotes":""},"categories":[8],"tags":[],"class_list":["post-3575","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sin-categorizar"],"_links":{"self":[{"href":"https:\/\/desertking.com\/es\/wp-json\/wp\/v2\/posts\/3575","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/desertking.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/desertking.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/desertking.com\/es\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/desertking.com\/es\/wp-json\/wp\/v2\/comments?post=3575"}],"version-history":[{"count":0,"href":"https:\/\/desertking.com\/es\/wp-json\/wp\/v2\/posts\/3575\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/desertking.com\/es\/wp-json\/wp\/v2\/media\/3511"}],"wp:attachment":[{"href":"https:\/\/desertking.com\/es\/wp-json\/wp\/v2\/media?parent=3575"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/desertking.com\/es\/wp-json\/wp\/v2\/categories?post=3575"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/desertking.com\/es\/wp-json\/wp\/v2\/tags?post=3575"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}