Vaccines for global epidemics – preclinical

This competition will support projects seeking to develop candidate vaccines and vaccine platform technologies at the preclinical stage. The aim is to enable an effective and rapid response during future outbreaks of disease. The UK Vaccine Network has identified these 12 pathogens as a priority:

• chikungunya
• Crimean-Congo haemorrhagic fever
• ebola
• hantavirus
• lassa
• marburg
• Middle-East respiratory syndrome
• nipah
• plague
• Q fever
• Rift Valley fever
• zika

All aspects of vaccine candidate development at the preclinical stage will be supported. These include, but are not limited to:

• developing master seed banks
• vaccine characterisation, formulation and adjuvantisation
• proof of concept ‘in vivo’ studies
• animal toxicology studies
• process finalisation. This involves moving from engineering batches to GxP activities (such as manufacturing and regulatory safety, pharmacology and toxicology studies
• process finalisation. This involves moving from engineering batches to GxP activities (such as manufacturing and regulatory safety, pharmacology and toxicology studies that follow good manufacturing practice). These will support the authorisation of future clinical trials

The funders are also interested in supporting 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 multivalent ebola plus marburg vaccine, or a vaccine against ebola, marburg and lassa.

This competition is wholly funded by Official Development Assistance. 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

Eligibility

This competition has two stages

Stage 1

• Applicants should explore the scientific, technical and commercial feasibility of their concept, which should focus on the development of vaccines and vaccine technology.
• Individual contracts will be worth up to £500,000.
• Projects are expected to last for up to 12 months.

Only projects that are supported in stage 1 will be eligible to apply for stage 2 funding.

Stage 2

• Individual contracts will be worth up to £2 million.
• Projects are expected to last up to 24 months.

It is expected that stage 1 of the competition will fund preclinical work. Awards made at stage 2 of the competition will fund further preclinical work, up to and including good laboratory practice toxicology/manufacturing. Stage 2 awards will also fund early clinical work, where this is feasible and appropriate.

A further launch of a vaccine development competition, focused on the clinical development of vaccines, is expected  in January 2017. This is for organisations that can move more rapidly to clinical work with their candidate vaccine.