Published: 26 April 2021
4,000 volunteers are set to be recruited to the latest vaccine study running in the UK, examining a new COVID-19 vaccine candidate.
Developed by specialty vaccine company Valneva, the vaccine is being manufactured at the company’s site in Livingston, West Lothian. It is the only inactivated, adjuvanted (an ingredient to create a strong immune response) COVID-19 vaccine in clinical development in Europe.
The study will be running across 22 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.
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.
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 find out if you're eligible to take part, visit the Valneva study website.
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 Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme, said:
“Off the back of positive early study data, it is great to see the final stage of the Valneva study begin across the UK, coordinated by the NIHR Clinical Research Network. 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.
"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. Signing up to be contacted, if you are potentially interested in taking part in vaccine studies, is simple via the NHS COVID-19 Vaccine Research Registry."
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.”
To register interest in vaccine studies and sign up to be contacted by researchers, people can visit the NHS COVID-19 Vaccine Research Registry.
The 24 sites involved in the study include:
- NIHR Cambridge Biomedical Research Centre
- Royal Surrey NHS Foundation Trust
- Lakeside Healthcare Research, Corby
- Nottingham University Hospitals NHS Trust
- Northern Care Alliance NHS Group, Salford
- Liverpool University Hospitals NHS Foundation Trust
- Blackpool Teaching Hospitals NHS Foundation Trust
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust
- Northumbria Healthcare NHS Foundation Trust
- Royal Free London NHS Foundation Trust
- University College London Hospitals NHS Foundation Trust
- Chelsea and Westminster Hospital NHS Foundation Trust
- St George's University Hospitals NHS Foundation Trust
- University Hospitals Plymouth NHS Trust
- Southampton University Hospitals NHS Trust
- University Hospitals Coventry & Warwickshire NHS Trust
- University Hospitals Birmingham NHS Foundation Trust
- University Hospitals Bristol and Weston NHS Foundation Trust
- North Bristol NHS Trust
- Cheadle Hospital, Midlands Partnership NHS Foundation Trust
- Barnsley Hospital NHS Foundation Trust
- Warrington and Halton Teaching Hospitals NHS Foundation Trust
- Queen Elizabeth Hospital-Glasgow - NHS Greater Glasgow
- Western General Hospital, Edinburgh - NHS Lothian