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Volunteers needed across NHS Greater Glasgow and Clyde and NHS Lothian for latest COVID-19 vaccine study
26th April 2021
The latest vaccine study to open in the UK examining a new COVID-19 vaccine candidate is recruiting volunteers across Greater Glasgow and Clyde and Lothian
Developed by the specialty vaccine company Valneva, the vaccine is being manufactured at the company’s site in Livingston, West Lothian, and is the only inactivated, adjuvanted (an ingredient to create a stronger immune response) COVID-19 vaccine in clinical development in Europe. Inactivated vaccines are a well-established technology used over the last 100 years to vaccinate billions – including for seasonal flu, hepatitis A, polio and rabies.
Following positive safety and immunogenicity study results from the Phase 1/2 stage, which showed the study vaccine dose was “well tolerated with no safety concerns identified”, recruitment to the final Phase 2/3 stage of the study will begin in the final week of April.
The study will be running across 25 National Institute for Health Research (NIHR) sites in England, and two sites in Scotland, and is open to healthy adults who have not had a previous COVID-19 vaccine.
Unlike earlier COVID-19 vaccine studies, which involved a placebo dose, everyone involved in this trial will receive two active vaccine doses, administered in a four-week interval. Those enrolled in the study over the age of 30 will be randomised to receive two doses of either the Valneva vaccine, or the approved Oxford/AstraZeneca vaccine. While participants aged 18 - 29 can be enrolled into the study to receive the Valneva vaccine.
Subject to successful Phase 2/3 data, Valneva aims to make regulatory submissions for initial approval in the autumn of 2021.
If Valneva’s vaccine is shown to be safe and effective, up to 250 million vaccine doses could be supplied to the UK and other countries around the world. As part of the UK government’s vaccine procurement approach, up to 100 million doses of this vaccine have been secured.
Volunteers for the study will be vaccinated at the beginning of May, and a proportion of potential participants will be identified through the NHS COVID-19 Vaccine Research Registry, which currently has over 480,000 sign-ups.
To register interest in vaccine studies and sign up to be contacted by researchers, people can visit the NHS COVID-19 Vaccine Research Registry.
Professor Julie Brittenden, Director of Research and Innovation, NHS Greater Glasgow and Clyde, said: "Vaccines are an incredibly important tool for our fight against COVID-19 and it is important research continues so we can understand what vaccines work best for different groups of people.
"The team based at our Glasgow Clinical Research have been at the forefront of COVID research over the past year, and are pleased to have the opportunity to help test this new type of vaccine.
"Please help us by volunteering to take care part in this novel trial by registering at www.nhs.uk/researchcontact."
Prof Clifford Leen, Lead clinician for clinical research in the Regional Infectious Disease Unit at the Western General Hospital, Edinburgh, and study lead said: "Evaluating an additional vaccine candidate to help protect the population against COVID-19 is vital in our efforts to ensure that we have effective vaccines that work for everybody. It is great to see the final stage of the Valneva study open in Edinburgh and other sites across the UK. This is a huge collaborative effort and each and every one of the participants involved in the study are key to helping us gain a detailed understanding of how the vaccine will perform in a large population.
"People are still needed from all backgrounds to take part in this and future vaccine studies. If you are potentially interested in taking part in vaccine studies, it is simple to sign up via the NHS Vaccine Research Registry."
