{"id":12518,"date":"2019-03-06T23:28:11","date_gmt":"2019-03-06T22:28:11","guid":{"rendered":"https:\/\/www.hollandbio.nl\/?p=12518"},"modified":"2019-03-12T23:51:47","modified_gmt":"2019-03-12T22:51:47","slug":"first-in-human-results-of-nasal-spray-rsv-vaccine-well-tolerated-and-capable-of-inducing-long-lasting-immune-responses","status":"publish","type":"post","link":"https:\/\/www.hollandbio.nl\/en\/nieuws\/first-in-human-results-of-nasal-spray-rsv-vaccine-well-tolerated-and-capable-of-inducing-long-lasting-immune-responses\/","title":{"rendered":"Virtuvax Reports Positive First-in-Human Results of Nasal Spray RSV Vaccine"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Virtuvax and\nthe trustee of biotech company Mucosis, Mr. Holtz LLM announced the results of\na first-in-human study of the intranasal Respiratory Syncytial Virus (RSV)\nvaccine candidate, SynGEM. The study was executed by Imperial College London.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Results of <a href=\"https:\/\/www.atsjournals.org\/doi\/abs\/10.1164\/rccm.201810-1921OC\"><strong>the study<\/strong><\/a> have been posted (in press) on the website of the American Journal of Respiratory and Critical Care Medicine. The vaccine was found to be safe and immunogenic in healthy adults.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cVirus-specific\nimmunogenicity induced after SynGEM vaccination was demonstrated by systemic\nIgG+ and IgA+ responses in terms of antibody-secreting cells (ASCs)\u201d indicated\nprof. Openshaw, professor of Experimental Medicine at Imperial College London.\nProfessor Openshaw added that \u201cSynGEM induced some RSV-specific mucosal IgA in\nmost individuals, particularly in those with low pre-existing F-specific IgA\ntiters. Indeed, higher doses of the vaccine induced prolonged IgA-producing ASC\nresponses in some volunteers.\u201d Prof. Openshaw further explained that \u201cThe\npublication includes in vitro data supporting the clinical observations,\nshowing that SynGEM induces a dose-dependent antibody response associated with\ncytokine production from T-helper cells.\u201d <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dr. Chiu,\nprincipal investigator of the clinical trial, commented: \u201cPreviously, we showed\nthat antibodies induced by natural RSV infection were only short-lived and we\nhypothesized that RSV-induced immunomodulatory mechanisms impaired the antibody\nresponses against the virus. In this study, SynGEM not only induced immune\nresponses but also boosted long-term systemic RSV-specific antibodies for at\nleast 6 months. Vaccination with the SynGEM RSV vaccine therefore was not\nassociated with evidence of immune modulation, as seen after infection with\nlive RSV.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In another\npublication also in AJRCCM, senior author Prof. Louis Bont of University\nMedical Center Utrecht, The Netherlands commented on the SynGEM trial. Prof.\nBont argued that in the absence of a correlate of protection to RSV, vaccine\ndevelopers are working in the dark. In the case of SynGEM, preclinical data had\nshown protection against infection suggesting evidence of the vaccine providing\nprotective immunity. However, despite the induction of broad immune responses,\nneutralizing antibodies were not detected in the clinical trial. In their\ncomment, the authors suggested that testing of the SynGEM vaccine in a human\nchallenge model might be a quick way to finally determine proof of concept of\nefficacy.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The\ninvestigators of Imperial College were surprised that no detectable\nneutralizing antibody responses were found, since extensive stability tests had\nshown stable binding of such antibodies by SynGEM. Openshaw said: \u201cthe system\nneeds further optimization, but establishes proof of principal that the nasal vaccine\napproach can work. It was a shame that the programme was ended before the\ninfection challenge component could be performed\u201d. Trustee of Mucosis, Mr.\nHoltz, commented: \u201cDuring the clinical trial, Mucosis was confronted with a\nsudden shortage of finances and the company had to apply for bankruptcy before\nthe final results were known as published today. Since these long-term data\nhave become available as of now, any further development of the vaccine may be\ntaken forward by other companies interested in doing so.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">SynGEM is\nbased on a unique pre-fusion version of the F subunit of RSV, shown to raise\nmore potent serum neutralizing antibodies against RSV compared with the\npost-fusion F antigen approach others have used. The pre-fusion conformation\n(pre-F), which predominates on infectious virions, displays a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">distinct\nantigenic site (site \u00d8) preferentially targeted by the most potent neutralizing\nantibodies. Preclinical studies using SynGEM showed induction of high levels of\nboth systemic and mucosal antibodies.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Delivered\nvia the mucous membranes in the nose, the vaccine candidate is also able to\nrecruit antibodies produced in the mucosal linings of the body, with the\npotential to effectively stop the virus from entering the body via the mucosal\npathways, where over 90% of pathogens enter the body.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">SynGEM is\nbased on Mucosis\u2019 patented Mimopath technology, which uses bacterium-like\nparticles (BLP) derived from food-grade bacteria, to deliver the antigen in a\nmore natural conformation and boost the body\u2019s immune response to the virus.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">RSV is a\ncommon contagious infection of the lungs and respiratory pathways, eliciting\ncold-like symptoms in adults. Whilst RSV infection is normally mild in healthy\nadults, the infection can lead to serious and sometimes fatal diseases such as\npneumonia and bronchiolitis, most often in susceptible populations such as the\nyoung and elderly. Every year in the US, RSV infections lead to 57,527 hospitalizations\nof children under 5 year\u2019s old (2)and are responsible for up to 200,000 deaths\nannually worldwide (3). The annual global burden of RSV illness is significant,\nwith 33.8 million estimated new episodes of RSV-associated acute lower\nrespiratory infection (ALRI) worldwide in children under 5, and over 3.4\nmillion hospital admissions associated with severe RSV disease. Global\nmortality was estimated at 253,500 deaths in 2010.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Wellcome Trust translational fund supported the clinical trial of SynGEM with a staged award of up to \u20ac3.44 million (\u00a32.77 million).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Source <a href=\"https:\/\/www.virtuvax.nl\/single-post\/2019\/03\/06\/First-in-Human-Results-of-SynGEM-Demonstrate-that-the-RSV-Vaccine-Is-Well-Tolerated-and-Capable-of-Inducing-Long-Lasting-Immune-Responses\"><strong>Virtuvax<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Virtuvax and the trustee of biotech company Mucosis, Mr. Holtz LLM announced the results of a first-in-human study of the intranasal Respiratory Syncytial Virus (RSV) vaccine candidate, SynGEM. The study was executed by Imperial College London. Results of the study have been posted (in press) on the website of the American Journal of Respiratory and [&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-12518","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>Virtuvax Reports Positive First-in-Human Results of Nasal Spray RSV Vaccine - 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\/first-in-human-results-of-nasal-spray-rsv-vaccine-well-tolerated-and-capable-of-inducing-long-lasting-immune-responses\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Virtuvax Reports Positive First-in-Human Results of Nasal Spray RSV Vaccine - hollandbio\" \/>\n<meta property=\"og:description\" content=\"Virtuvax and the trustee of biotech company Mucosis, Mr. Holtz LLM announced the results of a first-in-human study of the intranasal Respiratory Syncytial Virus (RSV) vaccine candidate, SynGEM. 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