New Covid-19 vaccine study launches
Published: 30 April 2021
A new Covid-19 vaccine study is being launched across sites in the UK, including the Vaccine Institute at St George’s, University of London and St George’s Hospital.
The National Institute for Health Research (NIHR)-supported Valneva Phase 2/3 study, will be run across four sites in London, and 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. It is the only Covid-19 vaccine in clinical development in Europe in which the virus is inactivated during its making and which is adjuvanted, meaning it contains an ingredient to create a stronger immune response.
This study follows increases the portfolio of Covid-19 vaccine trials run out of St George’s to nine trials since the start of the pandemic.
Professor Paul Heath, Principal Investigator on the trial at St George’s and Director of the Vaccine Institute, 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. Pre-screening for people who would like to register specifically for the Valneva trial can be found on the study website.
This work extends a portfolio of work at St George’s to tackle the coronavirus pandemic. The University has launched a Coronavirus Action Fund to raise money for vital research into the pandemic and is actively seeking support for a broad research programme involving all parts of the University.