COVID-19 vaccine study to be launched in York
The latest COVID-19 vaccine study in the UK is to open today (Thursday 6th May) in Yorkshire and Humber.
Medicago, a biopharmaceutical company based in Canada, and GlaxoSmithKline (GSK) are launching the Phase 3 randomised, observer blinded, placebo-controlled study. The National Institute for Health Research (NIHR)-supported study, which will be run at the York and Scarborough Teaching Hospitals is the first to test a plant-derived COVID-19 vaccine candidate, and will evaluate the efficacy and safety of the Coronavirus-Like Particle COVID-19 Vaccine (CoVLP).
1,500 volunteers will be recruited to the study within the UK, and each will receive an active study vaccine dose as part of the trial’s blinded crossover design. Healthy adults between the age of 18 to 39-year-old will be asked to take part in the study, which will look to recruit over the course of the next four to six weeks.
Participants will receive two doses of the experimental vaccine and two doses of a placebo. For both rounds of vaccinations, each two injections will be given 21 days apart. Those who receive the CoVLP vaccine in Period 1 will receive the placebo in Period 2, while participants who receive the placebo in Period 1 will receive the experimental vaccine in Period 2. Study participants will then be followed up for safety and immunogenicity for a period of 12 months after their last vaccination.
Eleven National Institute for Health Research (NIHR) sites, and three sites across Scotland and Wales, will run the Medicago vaccine study, in addition to multiple sites in the United States, Canada, Europe and Latin America. The study will enroll up to 30,000 volunteers worldwide.
A proportion of the volunteers involved in the trial will be identified through the NHS COVID-19 Vaccine Research Registry, which enables the UK public to support the national effort to speed up vaccine research. Over 460,000 people have already signed up to the Registry, giving their permission to be contacted about taking part in vaccine research and more volunteers are still needed.
The Registry was launched by the UK government in partnership with the NIHR, NHS Digital, the Scottish and Welsh governments and the Northern Ireland Executive in July 2020, and has helped recruit participants to several COVID-19 vaccine studies.
This is the sixth NIHR-supported vaccine to be delivered in the UK, alongside the Oxford/AstraZeneca, Imperial College London, Novavax, Janssen and Valneva studies which are currently at different stages of completion.
Professor Charles Lacey from the Hull York Medical School, Principle Investigator for the trial in York said:
“Clinical studies are important for medical advances. Current available vaccines are only available because of research study volunteers. Although there are several approved COVID-19 vaccines available, research is ongoing to provide more options, since all vaccines may work differently in providing protection against COVID-19. The vaccine we are trialling showed very exciting results in phase 1/2 studies.
"Researchers will compare a placebo vaccine with the study vaccine, with participants crossing over during the trial and receiving both. Participants will not know when they are receiving the placebo or the investigational vaccine."
Lydia Harris, Head of Research and Development at York and Scarborough Teaching Hospitals NHS Foundation Trust, said:
“York is rapidly expanding its research capabilities. The quality of our researchers, facilities and patient groups are allowing us to engage effectively in cutting edge research at an international level. We have come a long way in a very short period of time.”
“Our staff are doing incredible work to support COVID-19 research studies and we are very proud to have made significant contributions to this global effort.
“We’re really proud to be contributing to so many different studies for COVID-19. Our success in these areas has led to us being invited, as part of a cross Clinical Research Network (CRN) collaboration with additional resources being provided by York University and Tees, Esk and Wear Valleys NHS Foundation Trust, to take part in a unique COVID-19 Vaccine Trial.”
Dr Chrissie Jones, Associate Professor in Paediatric Infectious Diseases at University of Southampton, and Chief Investigator for the study said:
"Clinical trials of COVID-19 vaccines are still needed in the UK to ensure that we have access to a range of different vaccines which are safe and effective. The Medicago COVID-19 vaccine candidate is unique in that it is developed within plants which produce non-infectious versions of the virus. This is really exciting, as this plant-based platform can very rapidly produce new vaccines, on a large-scale.”
Prof Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme, said:
“We are pleased to see this latest vaccine study launch in the UK and evaluate another COVID-19 vaccine candidate to help protect the population. The NIHR and the 14 NIHR research sites involved in this study are dedicated to working alongside volunteers to gain robust data on safety and effectiveness of the study vaccine.
"To ensure we have several effective COVID-19 vaccine options that work for everyone, people are still needed from all backgrounds to take part in vaccine studies. Signing up to be contacted about taking part in vaccine studies is simple via the NHS Vaccine Research Registry."