Competition brief: vaccines for global epidemics - clinical
Updated 12 April 2017
© Crown copyright 2017
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/sbri-funding-competition-vaccines-for-global-epidemics-clinical/competition-brief-vaccines-for-global-epidemics-clinical
1. Dates and deadlines
| Competition opens | Monday 23 January 2017 |
| Registration deadline | Midday (12.00pm) on Wednesday 12 April 2017 |
| Application deadline | Midday (12.00pm) on Wednesday 19 April 2017 |
2. The competition scope
This competition will support projects seeking to develop candidate vaccines and vaccine platform technologies at the clinical stage. The aim is to enable an effective and rapid response during future outbreaks of disease. The UK Vaccine Network has identified 12 pathogens as a priority:
- chikungunya
- Crimean-Congo haemorrhagic fever
- ebola
- hantavirus
- lassa fever
- Marburg virus
- Middle East respiratory syndrome
- nipah
- plague
- Q fever
- Rift Valley fever
- zika
We will support the clinical development of candidate vaccines up to and including phase IIb trials. The competition funders will also consider co-funding phase III trials, either with industry or other philanthropic or government funders. This would include, where it is feasible, through epidemiology to show the safety and effectiveness of a vaccine in natural disease conditions.
The competition funders are particularly keen to support:
- high-risk proof of concept. This involves applying emerging or existing vaccine platform technologies from other areas of vaccinology to the 12 priority diseases
- testing vaccine platform technologies in humans to improve the efficacy of existing strategies. Examples could include, but are not limited to, new and improved adjuvants, or changes to vaccination regimen to augment an improved immune response
- testing proven animal vaccines based on strong data to support their use in humans
- developing vaccines for the 12 priority diseases for use with relevant animal populations to reduce the risk of transmission to humans
- vaccine delivery technologies that would allow for easier, simpler and more efficient administration
- diagnostics that can be used to demonstrate safety and/or correlates of immunity. This includes those that show functional correlates of immunity
- ambitious multivalent candidate vaccines. These could protect against multiple strains of a single pathogen, or against multiple pathogens. For example, applicants could develop a multivalent ebola vaccine, a trivalent ebola plus Marburg vaccine, or a vaccine against ebola, Marburg and lassa fever
This competition is wholly funded by Official Development Assistance (ODA). This means that vaccines developed as part of the competition should be appropriate for use in low- and middle-income countries (LMICs) and outbreak settings. Therefore applicants should also consider:
- ease and speed of manufacture
- ease of use in LMIC settings
- temperature stability
- vaccines that require a single dose or a low number of boosts
- length of protection
- serologic markers of efficacy
- biomarkers or correlates of vaccine safety
3. Projects that we won’t fund
In this competition we are not funding projects covering:
- diagnostics that do not meet the criteria set out above
- pre-clinical discovery work (with the only exception being for a single, short milestone that may be required to reach a go/no-go decision to rapidly move into a clinical trial)
- vaccines that are not on the UK Vaccine Network’s priority list
4. Find out if you are eligible to apply
This competition is open to academic, industry and government bodies. You must demonstrate that your product has a realistic route to exploitation. However, we recognise that this is a complex procedure, given the priority diseases listed.
5. Funding and project details
This competition is a single-stage SBRI. It is wholly funded by UK Official Development Assistance through the Department of Health.
We have allocated £35 million for the clinical development of vaccines up to and including phase IIb trials. We expect that individual contracts will be worth up to £3 million. However, we will consider making larger awards on a case-by-case basis. We expect projects to last between 24 and 36 months.
If the Department of Health does not distribute the entire £35 million available, the competition will reopen in 2018.
This competition is aimed at supporting candidate vaccines that are ready for, or close to moving into phase I clinical trials. This can include good laboratory practice toxicology or manufacturing activity to support the proposed clinical trial.
Applicants must describe the candidate vaccine or vaccine platform technology they are developing. They should give details of its:
- competitive advantage over alternative solutions
- relevance to global epidemic disease threats
- anticipated clinical application
- estimated medical benefit and value. This includes its potential for use in LMICs
Applicants should describe how the product or capability would be used, where and by whom. Applications should include evidence that the technologies and models are appropriate and fit for purpose. Additional scientific data supporting the rationale and approach should be submitted as a separate attachment. Please refer to the application form and Guidance for Applicants for further details.
Project proposals must also demonstrate strict compliance with all necessary regulations. Applicants should provide a project plan of the work needed to demonstrate compliance. This could include, if relevant, how they intend to engage with overseas regulators to conduct in-country trials.
Proposals should include an example of validation of the candidate vaccine. Projects should identify an effective, credible pathway for future development. Proposals should describe the health and economic benefits of the proposed product. Proposals should show how the product may be used in an outbreak. They should also include a product development plan, including the costs to develop the vaccine to market.
The application should include details on the manufacturing process with a credible production plan. The trial design needs to be clearly presented and justified. There should also be a clear explanation of the statistical methodology. It should include sample size and power analysis.
6. How to apply
To apply:
- the lead applicant must register online
- read the guidance for applicants for this competition
- watch the recording of the pre-clinical briefing event
- complete and upload your online application on our secure server
We will not accept late submissions. Your application is confidential.
External, independent experts will assess the quality of your application.
Please read the general Guidance for Applicants before you apply. It will help your chances of submitting a quality application.
7. Background and further information
Vaccines are one of the most cost-effective health interventions ever developed. They prevent millions of deaths worldwide every year. However, there is a strong need to develop new vaccines and to improve the efficacy and effectiveness of existing ones.
The UK Vaccine Network was established in June 2015. Since then, it has been working with the Department of Health, the Medical Research Council and the Biotechnology and Biological Sciences Research Council to fund the research and development of vaccines against epidemics. This is to make sure that the UK and the wider international community are better prepared for, and able to respond to, future outbreaks of infectious disease.
About SBRI competitions
SBRI provides innovative solutions to challenges faced by the public sector. This can lead to better public services and improved efficiency and effectiveness. SBRI supports economic growth and enables the development of innovative products and services. It does this through the public procurement of research and development (R&D). SBRI generates new business opportunities for companies and provides a route to market for their ideas. It also bridges the seed funding gap experienced by many early-stage companies.
Applications must have at least 50% of the contract value attributed directly and exclusively for R&D services. R&D can cover solution exploration and design. It can also include prototyping and field-testing the product or service. R&D does not include:
- commercial development activities such as quantity production
- supply to establish commercial viability or to recover R&D costs
- integration, customisation or incremental adaptations and improvements to existing products or processes
Further help and information
If you want help to find a project partner, contact the Knowledge Transfer Network.
If you need more information, contact the competition helpline on 0300 321 4357 or email us at support@innovateuk.gov.uk.