By Lucy Ashton
The latest vaccine study to open in the UK examining a new COVID-19 vaccine candidate is recruiting up to 200 volunteers in the local health board area.
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. Participants aged 18 – 29 can be enrolled into the study to receive the Valneva vaccine and will not be offered the approved Oxford/AstraZeneca 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 (www.nhs.uk/researchcontact).
Professor Adam Finn, Chief Investigator for the Valneva study said: “Following very encouraging safety and immune response results from our phase 1 study, along with my investigator colleagues, I am really looking forward to starting on this important next stage of the clinical development of this important new vaccine.
“We definitely need more vaccines to help us out of this pandemic and this one is a very promising candidate.”
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.”
Thomas Lingelbach, Chief Executive Officer of Valneva, said: “As COVID-19 continues to impact people’s daily lives, Valneva remains fully focused on developing another safe and efficacious vaccine solution. The world needs multiple vaccines and we believe that ours has an important role to play – including boosters or potential modifications to address variants.
“The initiation of this trial marks a significant milestone in the development of the only inactivated vaccine candidate against COVID-19 in clinical trials in Europe. We are grateful to the NIHR for its continued support and to everyone who volunteers to make clinical trials possible.”
Professor Emma Thomson, Professor in Infectious Diseases at University of Glasgow Centre for Virus Research, and study lead in Glasgow, 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 Glasgow 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, is simple to sign up via the NHS Vaccine Research Registry.”