Volunteers needed for latest UK COVID-19 vaccine study launched in London

Volunteers from London are being asked to sign up to the latest COVID-19 vaccine study to be rolled out across the UK.

The National Institute for Health Research (NIHR)-supported Valneva Phase 2/3 study, will be run at University College London Hospitals NHS Foundation Trust (UCLH), The Royal Free London NHS Foundation Trust, St George's University Hospitals NHS Trust and Chelsea and Westminster Hospital NHS Foundation Trust.

The study is open to healthy adults who have not had a previous COVID-19 vaccine.

In total, 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 specialist 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.

Professor Vincenzo Libri, Director of the NIHR UCLH Clinical Research Facility which oversees the COVID-19 vaccine trial program at UCLH, and co-Investigator of the Valneva trial said: “We are proud to add this Covid-19 vaccine trial to our portfolio and to continue as a leading UK hospital in the prevention of this horrendous disease. We encourage as many volunteers as possible to take part in the trial, hopefully for their own protection and to contribute to the development of a new safe and effective vaccine.”

Dr Fiona Burns, who is leading the trial for The Royal Free London NHS Foundation Trust, said: “We strongly encourage people to sign up in this trial, as more safe and effective vaccines are needed to protect the population.”

Dr Marta Boffito, Principal Investigator of the trial at Chelsea and Westminster Hospital NHS Foundation Trust, said: “It's critical to continue clinical studies into COVID-19 vaccines to help find several safe and effective candidates to help protect us all. Volunteers in London are still needed to help carry out these studies.

“Anyone interested can visit nhs.uk/researchcontact to sign up to be contacted about taking part in COVID-19 vaccine studies.”

Professor Paul Heath, Principal Investigator on the trial at St George’s, University of London, and St George's Hospital, said: “At St George’s, we are delighted to be recruiting to this new trial with a COVID-19 vaccine that has shown great promise in its early phase trials. The Valneva vaccine is a whole virus, inactivated, adjuvanted vaccine and is the first COVID-19 vaccine of this type to be tested in Europe. We are hopeful that the trial will result in another safe and effective COVID-19 vaccine being added to our national vaccine programme."

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 485,000 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.”

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.”