Open Orphan plc (LON:ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, has announced that the first volunteer has been dosed with the Codagenix Inc. needle free, intranasal COVID-19 vaccine, COVI-VAC. Conducted by hVIVO,, 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 www.FluCamp.com.
“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.”
Cathal Friel, told DirectorsTalk: “We are delighted to confirm that the first volunteers have been dosed with the New York based Codagenix Inc’s next generation COVID-19 vaccine which is a single-dose, intranasal, live attenuated (the entire virus in a weakened form) vaccine as part of this phase I, first in human study at our Whitechapel quarantine facility. This is an exciting milestone in the development of this vaccine which is one of the first of the next generation COVID-19 vaccines. This vaccine is exciting for a number of reasons, firstly, it is a live attenuated vaccine and as such has the potential to provide much longer-lasting cellular immunity against COVID-19 than many of the first-generation vaccines that only target part of the virus, or the viral spikes, this could prove important as SARS-CoV-2 has begun to mutate. Secondly, COVI-VAC has the potential to address some key logistical challenges, as this vaccine is intranasal it removes the need for syringes and needles and highly trained medical staff to administer it. Likewise, it does not require extremely low temperatures for storage and transport, standard refrigeration or freezing is all that is required. COVI-VAC, which is being manufactured by the Serum Institute of India uses technologies already in place at many global manufacturing facilities and as such, can be manufactured at large scale very easily for mass vaccination.
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. This study is not a challenge study which would primarily test efficacy and would be classified as a phase IIa or IIb but is rather a phase I randomised, double-blinded, placebo-controlled dose-escalation study will evaluate the safety and tolerability of this single dose, intranasal vaccine in 48 young healthy adult volunteers.”
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. 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 www.flucamp.com.
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 www.UKCovidChallenge.com.