Researchers are recruiting 4000 volunteers to take part in a study trialling a new coronavirus vaccine made in Scotland.
Developed by Valneva, the jab is being manufactured at the company’s site in Livingston, West Lothian.
It is the only inactivated, adjuvanted (an ingredient to create a stronger immune response) Covid-19 vaccine in clinical development in Europe.
Inactivated vaccines have been used over the last 100 years to vaccinate billions of people – including for seasonal flu, hepatitis A, polio and rabies.
After positive safety and immunogenicity study results from the first two phases of the trial, which showed the study vaccine dose was “well tolerated with no safety concerns identified”, recruitment to the final phase two/three stage of the study will start in the final week of April.
The study will run across 22 National Institute for Health Research (NIHR) sites in England, and two devolved administration sites in Scotland.
It is open to healthy adults who have not had a previous Covid-19 vaccine.
But unlike previous vaccine trials, those over 30 who participate will not be given a placebo and will instead receive either two doses of the Valneva candidate, or two doses of the approved Oxford/AstraZeneca jab.
Participants aged 18 to 29 can be enrolled into the study to receive the Valneva vaccine and will not be offered the approved Oxford/AstraZeneca vaccine.
If the trials are successful, Valneva aims to make regulatory submissions for initial approval in autumn this year.
Valneva can provide up to 250 million vaccine doses to the UK and other countries around the world, if the jab is proven to be safe and effective.
As part of the UK government’s vaccine procurement, up to 100 million doses of this vaccine have been secured.
Volunteers will be vaccinated at the beginning of May, and a proportion will be identified through the NHS Covid-19 Vaccine Research Registry, 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 phaseo one 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.”
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