Volunteers from the Kent, Surrey and Sussex area 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 Guildford, Surrey, jointly hosted by Royal Surrey NHS Foundation Trust and University of Surrey. It 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.
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.
The Valneva vaccine collaboration is not the first time the Surrey-based university and hospital have joined forces to improve public health. Their longstanding relationship has led to research advancing the use of immunotherapy in treating cancer. Currently, researchers from both organisations, alongside other institutions, are developing culturally relevant health messages for ethnic minority groups to help reduce the transmission of the virus, raise awareness of their susceptibility and enhance participation in the national vaccination programme.
Dr Hana Hassanin, who is the local Principal Investigator for the Royal Surrey NHS Foundation Trust and University of Surrey site and the Medical Director of Surrey Clinical Research Facility at the University of Surrey, said:
“Although there are a number of vaccines now available it is important that the scientific and medical community continue to develop and trial new inoculations, as we have seen a one size fits all approach does not apply to vaccinations. A variety of proven vaccines will also help protect countries from supply, or other, issues that may mean one vaccine becomes difficult to manufacture or distribute.
“Volunteers in the Kent, Surrey, Sussex region are still needed to help carry out these studies. Visit nhs.uk/researchcontact to sign up to be contacted about taking part in COVID-19 vaccine studies.
“I am delighted that the university and hospital are collaborating to become a study site for this vaccine. Collaboration is key in helping to tackle the threat of COVID-19 and this trial will be a springboard for strengthened collaboration between our two organisations.”
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.”