Fifth Covid-19 vaccine to be tested at four UK sites including Birmingham
A UK developed vaccine and the only one so far to use an inactive version of the virus is to be trialled on UK participants from today (Wednesday 16 December).
The new vaccine candidate - pioneered by Global biotech company Valneva and developed in Livingston, West Lothian - will be tested on 150 participants. Birmingham (University Hospitals Birmingham NHS Foundation Trust) is one of four National Institute for Health Research (NIHR) testing sites chosen nationally (the others are Bristol, Newcastle and Southampton).
These early phase 1 and 2 trials will show whether the vaccine produces a safe and effective immune response against COVID-19.
Should these early trials prove successful, larger clinical trials will be planned for April 2021 with over 4,000 UK volunteers testing two doses of the vaccine in two groups: those aged 18-65 and the over 65s.
If Valneva’s vaccine is proven to be safe and effective in clinical trials, 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, early access to 60 million doses of this vaccine has been secured.
This is the fifth vaccine to enter clinical trials in the UK, alongside Oxford/AstraZeneca, Imperial College London, Novavax and Janssen, whose studies are currently ongoing.
Some of the volunteers taking part in these latest clinical trials came through from the NHS COVID-19 Vaccine Research Registry, which enables the UK public to support the national effort to speed up vaccine research.
Over 365,000 people have already signed up to the Registry, giving their permission to be contacted about taking part in vaccine research and more volunteers are still needed.
The Registry was launched by the UK government in partnership with the NIHR, NHS Digital, the Scottish and Welsh governments and the Northern Ireland Executive earlier this year.
Professor Jeremy Kirk, Clinical Director of the NIHR Clinical Research Network West Midlands said: “It is really encouraging news that we now have five UK vaccines at trial stage. I would like to thank our research teams, healthcare workers and participants for the success we have achieved so far.
“Because there is unlikely to be a single solution to tackle coronavirus, it is really important that clinical trials into a number of COVID-19 vaccines continue. Different vaccines work in different ways and we still need to collect important information about which vaccines work best, which are most appropriate for different groups of people and which ones prevent infection and transmission.
“So for anyone considering signing up to the vaccine registry, please be assured that it is not too late to do so. This is a positive step we can take to help tackle the virus.”
Professor Adam Finn, Chief Investigator for the Valneva study said: “We are really pleased to be initiating this first-in-man phase 1 study in Bristol and continuing it in several other centres across the country in the New Year. This is a more traditional vaccine design than those that have been in the news recently, consisting of the whole SARS CoV2 virus that has been chemically inactivated. This kind of viral vaccine has been in widespread use for 60 years.
"Our team will be working hard through the Christmas holiday period to get the first participants enrolled and vaccinated. We are pleased to be adding further to the research already done via the NIHR in Bristol over recent months to test COVID-19 vaccines and we are really grateful to the many members of our community who continue to come forward and volunteer to take part in this important work.”
Business Secretary, Alok Sharma, said: “As we take these monumental first steps in rolling out our country’s first Covid-19 vaccine, we must remember that we need to have different vaccines available to protect the British public now and long into the future.
“Today we have more welcome news that clinical trials will begin in the UK to test the safety and effectiveness of Valneva’s vaccine, which is being developed right here in the UK. We are throwing our full weight behind its development and manufacture, ensuring that Valneva has the capabilities to supply hundreds of millions of doses of its vaccine to this country and around the world.”
Chief Executive Officer of Valneva, Thomas Lingelbach, said: “Our teams have been working extremely hard to develop our differentiated vaccine candidate and I would like to thank them, as well as the UK government, for their dedication and support.
“While conducting our first clinical trials, we are already ramping-up our manufacturing capacities and commencing production at full-scale so that we can make the vaccine widely available across the world assuming the vaccine is safe and effective.”
Notes to editors:
Valenva’s vaccine candidate, VLA2001, is a highly purified, inactivated vaccine candidate against the SARS-CoV-2 virus that uses manufacturing technology from Valneva’s Japanese Encephalitis Vaccine. The inactivation process preserves the structure of the virus’ S protein and is expected to induce a strong immune response. This is a proven technology already used in existing vaccines used for prevention of diseases such as flu, Japanese encephalitis, tick borne encephalitis, polio, and rabies.
The first clinical study will be a (open-label) dose-escalation, randomized (double-blinded), multicenter study with three study arms enrolling 50 subjects each. Vaccinations will be administered at Days 1 and 22 with follow-up visits up to 6 months after the second dose. This study is planned to enrol subjects tested negative for previous SARS-CoV-2 infection.
The second clinical study will be initiated upon availability of safety and peak titer immunogenicity data from the first clinical study.
Planned for April 2021, the second clinical study will be a randomized, controlled, observer-blinded study in subjects aged 18 years or older. Approximately 4225 subjects will be randomized to either receive VLA2001 or control. Subjects aged 18-65 years will receive VLA2001 at the dose selected based on study VLA2001, for subjects aged above 65 years a higher VLA2001 dose level will be evaluated as well. Vaccinations will be administered at Days 1 and 22, follow-up visits will be conducted for one year to assess safety in all subjects and to collect immunogenicity in a sub-set of study participants. This study will enrol subjects regardless of their SARS-CoV-2 serostatus.