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First volunteer dosed in COVID-19 clinical trial
First volunteer dosed in COVID-19 clinical trial.
About this update from Hvivo Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 1421L\n Open Orphan PLC\n 11 January 2021\n \n \n \n \n 11 January 2021\n \n \n Open Orphan plc\n \n \n (\"Open Orphan\" or the \"Company\")\n \n \n \n \n \n \n First volunteer dosed in intran\n \n \n asal COVID-19 vaccine clinical trial\n \n \n \n \n \n Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces that the first volunteer has been dosed with the Codagenix Inc. (\"Codagenix\") needle free, intranasal COVID-19 vaccine, COVI-VAC. Conducted by hVIVO, part of Open Orphan plc, the Phase I clinical trial of COVI-VAC is being carried out at their facility in the UK. COVI-VAC is a single-dose, intranasal, live attenuated (the entire virus in a weakened form) vaccine against SARS-CoV-2, the virus that causes COVID-19.\n \n \n Further to the Company's announcement on 28 July 2020, hVIVO is working in collaboration with US biotech Codagenix to conduct a Phase I study of COVI-VAC. This is a randomised, double-blinded, placebo-controlled dose-escalation study, and will evaluate the safety and tolerability of the single-dose intranasal vaccine candidate in 48 healthy young adult volunteers at hVIVO's state-of-the-art Quarantine Facility in Whitechapel, London. \n \n \n \n The study will also evaluate the vaccine's ability to provoke an immune response - measuring neutralising antibodies, mucosal immunity in the airway and cellular immunity. COVI-VAC has the potential to address several key logistical challenges to immunisation against SARS-CoV-2 at a global scale. As a single-dose, intranasally-delivered vaccine, COVI-VAC will not require a needle and syringe to be administered, nor ultra-low temperature freezers for storage. COVI-VAC can be manufactured on a large scale and supports ease of administration in a mass vaccination campaign. Codagenix expects to report initial data from the study by mid-2021.\n \n \n Cathal Friel, Executive Chairman, Open Orphan, commented:\n \"We are delighted to have been chosen by the New York based Codagenix to run this very important COVID-19 vaccine study in our quarantine clinic in London. This vaccine is one of the first of the next generation COVID-19 vaccines, it is a single...