The latest COVID-19 vaccine study in the UK is now open in North West London.
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 London North West University Healthcare NHS Trust, 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.
Several National Institute for Health Research (NIHR) sites, and 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.
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.
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. ”
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 11 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.”
Saddaf Shaheen, Assistant Director R&D at London North West University Healthcare NHS Trust, said:
“Our team, led by Dr Ashley Whittington (Consultant in Infectious Diseases) and supported by NIHR CRN North West London, are very pleased to be collaborating on another extremely important study which will enable us to assess if healthy people can be protected from COVID-19 with this new vaccine.
“It will give us valuable information on the safety of the vaccine and its ability to generate good immune responses against the virus.
“Participants in the trial will play a crucial role in the global search for a further vaccine that protects us all from COVID-19.”
Image: Steven Cornfield