{"id":24300,"date":"2024-01-03T20:30:00","date_gmt":"2024-01-03T20:30:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4303345_CN03345_0"},"modified":"2024-01-03T20:30:00","modified_gmt":"2024-01-03T20:30:00","slug":"gpn-vaccines-reports-positive-safety-and-immunogenicity-data-from-its-phase-1-trial-of-gamma-pn","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=24300","title":{"rendered":"GPN Vaccines Reports Positive Safety and Immunogenicity Data from its Phase 1 Trial of Gamma-PN"},"content":{"rendered":"\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">ADELAIDE, Australia<\/span>, Jan. 4, 2024 \/PRNewswire\/ &#8212; GPN Vaccines Ltd, a clinical-stage biotechnology company developing a&nbsp;<i>Streptococcus pneumoniae <\/i>vaccine to prevent life-threatening pneumonia, bacteraemia and meningitis, is pleased to announce positive safety and immunogenicity data from its Phase 1 trial of Gamma-PN, a non-adjuvanted whole cell-pneumococcal vaccine being investigated in adults aged 50 to 69 years.&nbsp;&nbsp;&nbsp;<\/span><\/p>\n<p>In this double-blind, randomised study with placebo and active controls, 120 participants received either two doses of 50, 250 or 1000 micrograms of Gamma-PN (n=30 per group); a single dose of licensed pneumococcal vaccine (Pneumovax-23&reg; or Prevenar 13&reg;, n=9 per group); or placebo.<\/p>\n<p>The study met its primary safety objective, demonstrating a safety profile suitable for further development. There were no serious adverse events following administration of Gamma-PN and systemic tolerability was considered excellent. Injection site reactions were largely confined to mild to moderate erythema and swelling, typically of short (1-2 day) duration, with the frequency and extent being dose-related. Local and systemic tolerability after the second injection of Gamma-PN was similar to that after the first.<\/p>\n<p>An immunological assessment of serum IgG responses to vaccination with Gamma-PN was performed using an ELISA developed and run by a GLP-accredited third-party laboratory. This demonstrated that&nbsp;Gamma-PN induced dose-dependent rises in serum IgG levels to Gamma-PN after both the first and second vaccine dose. Neutrophil activation in participants administered Gamma-PN was consistent with vaccine stimulation of innate immune responses.<\/p>\n<p>GPN Vaccines is also conducting additional immunological tests on serum and peripheral blood mononuclear cells (PBMCs), including an assessment of opsonophagocytic antibodies against <i>Streptococcus pneumoniae<\/i> serotypes covered by current licensed pneumococcal vaccines as well as serotypes not covered by such vaccines. These results will be reported once complete.<\/p>\n<p>Professor <span class=\"xn-person\">Paul Rolan<\/span>, GPN Vaccines&#8217; Chief Medical Officer commented &quot;I would like to extend my appreciation to all of the participants who volunteered to be in this clinical trial. The study demonstrated that&nbsp;Gamma-PN is safe, well tolerated and encompassed the doses to be selected for further clinical development. &quot;<\/p>\n<p>Dr <span class=\"xn-person\">Tim Hirst<\/span>, Chief Executive Officer and co-founder said &quot;I am delighted we can announce positive clinical trial results on our broad-spectrum pneumococcal vaccine designed to offer protection against all serotypes of <i>Streptococcus pneumoniae<\/i>. These results provide important insights that will support dose selection for future Phase 2 clinical trials&quot;.<\/p>\n<p>This trial was generously supported by a <span class=\"xn-money\">$1 million<\/span> grant from the South Australian Government&#8217;s Research and Innovation Fund (RIF).<\/p>\n<p><b>About GPN Vaccines<\/b><\/p>\n<p>GPN Vaccines is a public (unlisted) biotechnology company developing a vaccine against <i>Streptococcus pneumoniae<\/i>, which is responsible for causing life-threatening pneumonia, bacteraemia and meningitis, as well as otitis media (middle ear infections). Each year it causes 1-2 million deaths worldwide, killing more children than AIDS, malaria and tuberculosis combined. There are now more than 100 different serotypes of <i>S. pneumoniae<\/i> and the best vaccine currently on the market only protects against 20 of them. GPN Vaccines&#8217; product, called Gamma-PN, is being developed to protect children and adults against all <i>S. pneumoniae<\/i> strains, regardless of serotype.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ADELAIDE, Australia, Jan. 4, 2024 \/PRNewswire\/ &#8212; GPN Vaccines Ltd, a clinical-stage biotechnology company developing a&nbsp;Streptococcus pneumoniae vaccine to prevent life-threatening pneumonia, bacteraemia and meningitis, is pleased to announce positive safety and immunogenicity data from its Phase 1 trial of Gamma-PN, a non-adjuvanted whole cell-pneumococcal vaccine being investigated in adults aged 50 to 69 years.&nbsp;&nbsp;&nbsp; [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-24300","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>GPN Vaccines Reports Positive Safety and Immunogenicity Data from its Phase 1 Trial of Gamma-PN - My Blog<\/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:\/\/transmediavictoria.net.au\/?p=24300\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GPN Vaccines Reports Positive Safety and Immunogenicity Data from its Phase 1 Trial of Gamma-PN - My Blog\" \/>\n<meta property=\"og:description\" content=\"ADELAIDE, Australia, Jan. 4, 2024 \/PRNewswire\/ &#8212; 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