Dublin-listed pharmaceutical services company Open Orphan has received approval from the UK drugs regulator to conduct its nasal Covid-19 vaccine clinical trial.
The vaccine and antivirals tester said on Monday it had received approval from the UK’s independent Medicines and Healthcare Products Regulatory Agency (MHRA) to conduct a phase one study of Covi-Vac, in collaboration with US biotech Codagenix.
The trial, which was first announced on July 28th, will be carried out by Open Orphan’s subsidiary, hVIVO, and will evaluate safety and immunogenicity of a single-dose nasal vaccine candidate in 48 healthy young adult volunteers. The trial will take place at hVIVO’s quarantine facility in Whitechapel, London.
In a statement, Open Orphan said Covi-Vac was one of the few vaccines that used the live-attenuated virus (the entire virus in a weakened form), unlike most other vaccines, which contain only the viral spike. It is a needle-free, single-dose vaccine.
Open Orphan said the vaccine had the potential to induce broad antibody, cellular and mucosal immunity with a single intranasal dose, and it could be one of the first vaccines to provide long-term immunity from Covid-19.
The study is expected to begin in January 2021, with the initial data expected in the second quarter of 2020.
Executive chairman Cathal Friel said, with MHRA approval, the company would begin recruiting volunteers for this clinical trial.
“The volunteers who attend our unique quarantine facility in east London are expertly supervised in a safe, controlled clinical environment and could be contributing to the development of a new breakthrough vaccine candidate that has the potential to confer immunity to individuals over a much longer timescale,” he said.
If this trial demonstrates safety and immunogenicity, hVIVO will then support Codagenix as it moves into a larger phase two and phase three programme.