UK-based Scancell Holdings has announced that its first subject has been dosed in its COVIDITY clinical trial in South Africa. The trial is a partnership between Scancell and scientists at the Centre for Research on Global Virus Infections and the Biodiscovery Institute at the University of Nottingham and Nottingham Trent University.
The programme has received funding from Innovate UK, a part of UK Research and Innovation, and is being conducted from the University of Cape Town (UCT) Lung Institute, South Africa. Part one of the Phase I clinical trial will assess the safety and immunogenicity of two vaccine candidates, which will target the original and variant of SARS-CoV-2.
These vaccine candidates will be administered using the PharmaJet needle-free delivery system. This is the same system that is being used in India for the rollout of their Zydus Cadila COVID-19 vaccine, enabling nucleic acid vaccine delivery without the need for needles.
Following the demonstration of safety in South Africa, Scancell plans to seek approval from the MHRA in the UK, and build on the UK portion of the study. This extension of the trail will see COVIDITY given to healthy volunteers who have received two doses of an approved vaccine. The immune responses from this section can then be used to provide more durable protection against new variants of SARS-CoV-2.
“We are delighted that we have been able to start this trial so quickly following regulatory approval in South Africa,” said Prof Lindy Durrant, Chief Executive Officer, Scancell.
“The Scancell team and collaborators have worked diligently since the start of the pandemic to design, characterise, manufacture and deliver this second generation COVID-19 vaccine and we look forward to evaluating its clinical potential with our colleagues in South Africa.”
Honorary Prof Rod Dawson, Managing Director of the University of Cape Town Lung Institute, commented: “Novel vaccine candidates are required to increase the cover, strength, and durability of the global COVID-19 vaccination platform. The UCT Lung Institute is excited to partner with Scancell to investigate these promising new COVID-19 vaccine candidates.”