The National Institute for Health Research (NIHR)-supported Valneva Phase 2/3 study, will be run at North Tyneside General Hospital in North Shields and the Freeman Hospital in Newcastle, and 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. 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.
Developed by the specialty vaccine 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.
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.”
Dr John Steer, Principal Investigator of the Valneva phase 2/3 study at Northumbria Healthcare NHS Foundation Trust said: “Finding more than one vaccine candidate is crucial to help protect us all. I encourage you to visit the prescreening website if you are interested in taking part.”
Dr Ashley Price, Principal Investigator of the Valneva phase 2/3 study at The Newcastle upon Tyne Hospitals NHS Foundation Trust said: “We still need people to take part in Covid-19 vaccine studies, if you are interested in taking part in the study at the Freeman Hospital in Newcastle, please contact [email protected], call 0191 2820083 or visit the prescreening website.”
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.”
About the Valneva Study:
Positive safety and immunogenicity study results from the Phase 1/2 stage showed the study vaccine dose was “well tolerated with no safety concerns identified”.
There are expected to be 4,000 volunteers across 22 NIHR sites, and two Devolved Administration sites different sites in the trial, including:
- NIHR Cambridge Biomedical Research Centre
- Royal Surrey Hospital NHS Foundation Trust
- Lakeside Healthcare Research, Corby
- Nottingham University Hospitals NHS Trust
- Northern Care Alliance NHS Group, Salford
- Liverpool University Hospitals NHS Foundation Trust
- Blackpool Teaching Hospitals NHS Foundation Trust
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
- Northumbria Healthcare NHS Foundation Trust
- Royal Free London NHS Foundation Trust
- University College London Hospitals NHS Foundation Trust
- Chelsea and Westminster Hospital
- St George’s University Hospitals NHS Foundation Trust
- University Hospitals Plymouth NHS Trust
- Southampton University Hospitals NHS Trust
- University Hospitals Coventry & Warwickshire
- University Hospitals Birmingham NHS Foundation Trust
- University Hospitals Bristol and Weston NHS Foundation Trust
- North Bristol NHS Trust
- Cheadle Hospital, Midlands Partnership NHS Foundation Trust
- Barnsley Hospital NHS Foundation Trust
- Warrington and Halton Teaching Hospitals NHS Foundation Trust
- Queen Elizabeth Hospital-Glasgow- NHS Greater Glasgow
- Western General Hospital, Edinburgh- NHS Lothian
About the National Institute for Health Research
The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research. The NIHR:
- Funds, supports and delivers high quality research that benefits the NHS, public health and social care
- Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
- Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
- Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
- Partners with other public funders, charities and industry to maximise the value of research to patients and the economy
Volunteering for COVID-19 vaccine clinical trials:
People wishing to volunteer to support clinical trials can sign up for information on Covid-19 vaccine trials with the NHS Covid-19 Vaccine Research Registry, developed in partnership with NHS Digital. It is helping large numbers of people to be recruited into trials rapidly over the coming months – potentially meaning effective vaccines for coronavirus can be found as soon as possible.
The service was commissioned as part of the UK Government’s Vaccine Taskforce in conjunction with the National Institute for Health Research (NIHR) and the Northern Ireland, Scottish and Welsh Governments.
Anyone living in the UK can sign up online to take part in the trials through the NHS, giving permission for researchers to contact you if they think you’re a good fit. Once you sign up, you can withdraw at any time and request that your details be removed from the COVID-19 Vaccine Research Registry. The process takes about 5 minutes to complete.
More information can be found: NHS.UK/coronavirus
About the Vaccines Taskforce
The Vaccines Taskforce (VTF) is a joint unit in the Department for Business, Energy and Industrial Strategy (BEIS) and Department for Health and Social Care (DHSC). The VTF was set up to ensure that the UK population has access to clinically effective and safe vaccines as soon as possible, while working with partners to support international access to successful vaccines.
The Vaccines Taskforce comprises a dedicated team of private sector industry professionals and officials from across government who are working at speed to build a portfolio of promising vaccine candidates that can end the global pandemic.
The UK government has secured early access to 457 million vaccines doses through agreements with eight separate vaccine developers. This includes agreements with:
- ​BioNTech/Pfizer for 40 million doses
- Valneva for 100 million doses
- Oxford/AstraZeneca for 100 million doses
- GlaxoSmithKline and Sanofi Pasteur for 60 million doses
- Novavax for 60 million doses
- Janssen for 30 million doses
- Moderna ​for 17 million doses
- CureVac ​for 50 million doses
The Vaccines Taskforce’s approach to securing access to vaccines is through:
- procuring the rights to a diverse range of promising vaccine candidates to spread risk and optimise chances for success
- providing funding for clinical studies, diagnostic monitoring and regulatory support to rapidly evaluate vaccines for safety and efficacy
- providing funding and support for manufacturing scale-up and fill and finish at risk so that the UK has vaccines produced at scale and ready for administration should any of these prove successful
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. We have leveraged our expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
About VLA2001
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting,as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines.
VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO ® . VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B ® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).
