Open Orphan PLC (ORPH.L) First volunteer dosed in COVID-19 clinical trial

First volunteer dosed in intran asal COVID-19 vaccine clinical trial

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.

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.

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.

Cathal Friel, Executive Chairman, Open Orphan, commented: “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 dose, needle-free, intranasal, live attenuated COVID-19 virus vaccine. Thus, in our opinion, because it is a live attenuated virus vaccine, COVI-VAC has the potential to give much longer-lasting cellular immunity against COVID-19 than many of the first-generation vaccines.

“Codagenix sought an inpatient facility for the first in human evaluation of COVI-VAC to allow for thorough evaluation of product safety and real-time volunteer monitoring, and our unique state-of-the-art quarantine facility in East London is one of the few facilities in the world suitable to conduct this trial safely and successfully. hVIVO are providing a full-service trial as part of this contract with Codagenix and the team at FluCamp have been responsible for all aspects of trial recruitment for this study through .

“hVIVO is world-recognised for its expertise in evaluation of live viruses in human volunteers and we look forward to a positive outcome.”

Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said: “Dosing of the first patients in the Phase 1 clinical trial of COVI-VAC, our single-dose, intranasal, live attenuated vaccine against COVID-19, is an important milestone for Codagenix and the hVIVO team. As a live attenuated vaccine, COVI-VAC has the potential to provide a broader immune response in comparison to other COVID-19 vaccines that target only a portion of the virus, which could prove critical as new variants of SARS-CoV-2 have begun to emerge. Additionally, we believe COVI-VAC can address potential gaps in supplying the global immunization effort against COVID-19, especially in developing countries .”

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, . hVIVO welcomes volunteers to take part in our clinical trials under expertly supervised conditions, to further medical research, and help us to take the understanding of respiratory illnesses to a new level. Volunteers are central to the work that we do; our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.

Further details on all aspects of our volunteer programs including testimonials from previous volunteers can be found at .

If you are interested in being contacted and provided with details about future COVID-19 human challenge study research, please leave your contact details at .

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