Up to 200 volunteers are being recruited for a new Covid-19 vaccine which is the first of its kind.
It is the only inactive drug under clinical development in Europe which uses pathogen that has been modified so that it cannot replicate to stimulate our immune system.
It has also been adjuvanted, which means it contains substances that increase its potency to create a stronger immune response.
Inactivated vaccines are a well-established technology used over the last 100 years to vaccinate billions for seasonal flu, hepatitis A, polio and rabies.
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.
“We definitely need more vaccines to help us out of this pandemic and this one is a very promising candidate.”
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.
The study will be running across 25 National Institute for Health Research (NIHR) sites in England, and two sites in Scotland, and is open to healthy adults who have not had a previous Covid-19 vaccine.
It is being developed by Valneva at the company’s site in Livingston, West Lothian.
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.
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.
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 ResearchRegistry, which currently has over 480,000 sign ups.
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.”
Professor Julie Brittenden, Director of Research and Innovation, NHS Greater Glasgow and Clyde, said: “Vaccines are an incredibly important tool for our fight against COVID-19 and it is important research continues so we can understand what vaccines work best for different groups of people.
“The team based at our Glasgow Clinical Research have been at the forefront of COVID research over the past year, and are pleased to have the opportunity to help test this new type of vaccine."
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).
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