The latest vaccine study to open in the UK examining a new COVID-19 vaccine candidate is recruiting up to 200 volunteers in Glasgow.
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 in Europe. Inactivated vaccines are a well-established technology used over the last 100 years to vaccinate billions – including 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.
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.
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. 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 Research
Registry, which currently has over 480,000 sign ups.
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).
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.
“Please help us by volunteering to take care part in this novel trial by registering at www.nhs.uk/researchcontact.”
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.”
Prof Emma Thomson, Professor in Infectious Diseases at University of Glasgow Centre for Virus Research, and study lead in Glasgow, said:
“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. It is great to see the final stage of the Valneva study open in Glasgow and other sites across the UK. This is a huge collaborative effort and 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. If you are potentially interested in taking part in vaccine studies, is simple to sign up via the NHS Vaccine Research Registry."
Notes to editors:
About the Valneva Study (Non-inferiority study comparing immunogenicity against COVID-19 of VLA2001 with [ACTIVE COMPARATOR]):
There are expected to be 4,000 volunteers across 25 NIHR sites, and two Devolved Administration Scottish sites of different sites in the trial, including:
- NIHR Cambridge Biomedical Research Centre
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:
About NHS Research Scotland
NHS Research Scotland (NRS) simplifies access to Scotland’s world-class research infrastructure, supporting the placement, setup and delivery of clinical research studies and innovative research collaborations from all sectors and therapy areas. As a partnership of Scottish NHS Boards and the Chief Scientist Office (CSO) of Scottish Government, it ensures NHS Scotland provides the best environment to support research.
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:
The Vaccines Taskforce’s approach to securing access to vaccines is through:
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.
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).