The National Institute for Health Research (NIHR)-supported Valneva Phase 2/3 study will be run at Derriford Hospital, managed by University Hospitals Plymouth NHS Trust, in collaboration with researchers from Torbay and South Devon NHS Foundation Trust. The study is open to healthy adults who have not had a previous COVID-19 vaccine.
4,000 participants will be recruited across the UK, and everyone involved in the study 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.
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.
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. 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.
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.”
Dr Claire Bethune, Consultant Immunologist and Principal Investigator for the study at University Hospitals Plymouth, said: “Clinical studies into COVID-19 vaccines remain critical to help increase the number of safe and effective vaccines to help to protect us all. This is a great opportunity for volunteers from Plymouth, Torbay and the surrounding areas, who have not yet had a COVID-19 vaccine, to take part in a national COVID-19 vaccine research study. If you are over 18 and have not had a COVID vaccine please contact the COVID-19 vaccine research team in Plymouth by emailing firstname.lastname@example.org”
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 interested in taking part in vaccine studies, is simple via the NHS 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.”