Blog:
Advancing vaccine clinical trials
Dr. Maria Koufali outlines how the UK Vaccine Innovation Pathway will expand the country's vaccine research potential.
Building capacity and capability in vaccine clinical trial delivery
This page explains how we are working with delivery partners across the UK to expand our world-leading expertise and facilities in vaccine clinical trial delivery and outlines how this benefits commercial companies that choose to run vaccine clinical trials in the UK.
Your ‘go-to destination’ for vaccine research
The UK is a proven global-leader in vaccine development with a unique ability to deliver vaccine clinical trials at pace and scale. This was demonstrated the UK’s response to the COVID-19 pandemic and more recently by our track record in delivering clinical trials of cancer vaccines.
The NIHR has developed targeted support to ensure that the UK continues to be known as the ‘go-to destination’ for vaccine research - from traditional and mRNA vaccines to cancer vaccines such as personalised neoantigen cancer therapy. We are working with our delivery partners - the devolved administrations - to continue to build and enhance our capacity and capability through the UK Vaccine Innovation Pathway programme plan.
The UK Vaccine Innovation Pathway is the UK’s first clinical trial delivery accelerator (CTDA) being developed as part of the Government response to Lord O’Shaughnessy’s independent review into commercial clinical trials in the UK.
5 areas of targeted support
1. Early advice on vaccine protocol and pipelines
Our Independent Vaccine Research Forums provide researchers with access to a range of infection and cancer vaccine clinical experts who can provide early input and advice on vaccine protocols and pipelines. These global leaders in infectious diseases and cutting-edge cancer vaccines help ensure that the vaccine clinical trials coming to the UK are compatible and deliverable in our health and care system. The Forum member’s expertise spans different care settings (primary, secondary, specialist and community care) and specialist research facilities. Together, they hold unparalleled knowledge of the UK research infrastructure and NHS health and care settings.
2. Research-ready investigators and sites
Since April 2019, more than 500 UK sites have taken part in vaccine studies. During the pandemic, 200+ sites actively engaged in COVID-19 vaccine trials across primary, secondary, specialist (tertiary), and community care settings.
To enhance capacity for vaccine trials in these settings, we're conducting a nationwide assessment. This aims to identify sites across all healthcare settings that are planning or aspiring to contribute to future vaccine trials, and assess their capacity, capability, and skills. The findings are informing a national training matrix for workforce planning that will ensure the UK can sustain the increasing number and complexity of vaccine trials in different therapeutic areas including cancer, rare diseases and infectious diseases. It will also enable staff at each site to receive training to ensure equivalent high standards of vaccine research delivery capability.
As well as harnessing the expertise of our existing vaccine research leaders, we are also developing the next generation of clinician scientists, chief and principal investigators by facilitating mentoring and career development opportunities.
One example of this is through the NIHR Associate Principal Investigator Scheme (commercial pilot) which is designed to support healthcare professionals to become the principal investigators of the future. The scheme offers practical experience for healthcare professionals starting their research career giving them the skills and confidence to take on the responsibility for the conduct of a research study at a site and to become the PIs of the future.
Read how Dr Owen Hughes, a GP Partner at Cripps Health Centre, was supported by the Associate PI Scheme to get involved in research. The HARMONIE study - a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR) - became the first commercial study to be delivered under the Associate PI Scheme.
3. Vaccine study site identification
We use data, intelligence and expertise to identify the best site for your study based on your specific requirements. This includes:
- intelligence via the Independent Vaccine Research Forums and the national training matrix (detailed above) to quickly determine the sites with the capabilities, expertise and specialist research facilities required
- mapping of UK-wide vaccine research activity, including active and upcoming clinical trials, to coordinate capacity and improve distribution of research across the UK population; increasing both the speed and spread of vaccine research
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scoping of available digital systems to support recruitment, consent and clinical outcome data collection from primary and hospital care.
4. Recruit participants into your vaccine clinical trials
During the pandemic more than 50,000 people took part in vaccine clinical trials in the UK. Public awareness of the health benefits of vaccine research remains high. This was demonstrated in the post-pandemic HARMONIE trial - a Respiratory Syncytial Virus (RSV) vaccine trial - which recruited over 4000 infants in the UK in four months.
We are proactively engaging healthy volunteers, as well as patients, to register their interest in vaccine clinical trials in order to further build upon the Be Part of Research national registry which makes it easier for researchers and potential study participants to find each other.
To maintain this momentum, we are:
- growing and consolidating ‘consent to contact’ registries, such as the Be Part of Research registry
- putting systems in place so we can approach people through primary care data and digital systems
- continuing to build awareness through public campaigns.
We are also making participation easier through decentralised clinical trials and digital optimisation.
5. Cross-cutting areas of focus for continual improvement
Initiatives from across the UK research system are being enhanced specifically for the UK Vaccine Innovation Pathway to further improve vaccine trial delivery. These include:
- streamlining clinical trial set-up and administration including approvals, costing and introducing standardised wording for vaccine clinical trial contracts
- identifying and addressing capacity gaps in the system as a whole, such as in pharmacy and diagnostics
- developing the national network for clinical trial laboratory capability, e.g. for Peripheral Blood Mononuclear Cell (PBMC) processing
- developing robust mechanisms for tracking long-term outcomes data through the NHS healthcare system - a unique aspect of the UK that is difficult to replicate in other countries.
Contact us if you have suggestions for where we can further optimise the UK’s vaccine research potential.
Working across the UK
The UK Vaccine Innovation Pathway is a cross-sector programme supporting The Future of UK Clinical Research Delivery – a collective vision which aims to achieve faster, more efficient and more innovative clinical research delivery – making the UK one of the best places in the world to conduct research. Learn more on the Future of UK Clinical Research Delivery microsite.
It encompasses the NIHR and its equivalent organisations within the devolved nations. This includes the Clinical Research Network, UK Clinical Research Facilities Network (UKCRF), the Experimental Cancer Medicine Network (ECMC) and infrastructure in Scotland (NHS Research Scotland), Wales (Health and Care Research Wales) and Northern Ireland (Northern Ireland Clinical Research Network).
Further information
For information on how we support research in other therapeutic areas, visit NIHR support for the life sciences industry page (commercial research) or our Researchers page (non-commercial research).
If you would like to speak to our Vaccine Innovation Pathway experts, complete our contact form.
Blog:
Podcast:
Developing the pathway
This podcast is an essential listen for all those involved or interested in contributing to vaccine development and trial delivery in the UK.
Case study:
Primary care potential
Trailblazer GP, Rebecca Clark, showcases the potential of primary care for commercial vaccine research in this case study with video content.
Watch now
Vaccine research case studies
Browse all our case studies showcasing how we support vaccine research.
Contact us to discuss your vaccine development
If you are interested in delivering or contributing to vaccine trials in the UK, or want to know more about the UK Vaccine Innovation Pathway, get in touch.
We will connect you to one of our experts.
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