Up to 160 Lothian volunteers needed for latest UK Covid-19 vaccine study
The latest vaccine study to open in the UK examining a potential new Covid-19 vaccine is recruiting 160 volunteers across Lothian.
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.
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.
The study will be running across 25 National Institute for Health Research sites in England and two sites in Scotland, and is open to healthy adults who have not had a previous Covid 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. While participants aged 18 - 29 can be enrolled into the study to receive the Valneva vaccine.
Subject to successful Phase 2/3 data, Valneva aims to make regulatory submissions for initial approval in the autumn of 2021.
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.”
Volunteers for the study will be vaccinated at the start 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 register an interest in taking part in the vaccine studies, visit: www.nhs.uk/conditions/coronavirus-covid-19/research/coronavirus-vaccine-research/.
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.