Wellcome Trust: Seeking Predictors of Vaccine Efficacy – Identifying Correlates of Protection to Support Vaccine Development

Transdisciplinary teams will be funded to deliver projects that establish or validate correlates of protection across 11 diseases to support effective vaccine development, especially in low resource settings.

Founded in 1936, the Wellcome Trust is an independent foundation that seeks to improve health by supporting researchers, addressing big health challenges, campaigning for better science and encouraging everyone to get involved with science and health research.

Up to £5 million per award is available through the Trust’s Seeking Predictors of Vaccine Efficacy – Identifying Correlates of Protection to Support Vaccine Development call to support research teams to establish or validate correlates of protection across 11 diseases with the potential to cause substantial outbreaks or which have significant burden and have no licenced vaccines. The aim is to develop a range of reliable metrics to predict vaccine efficacy to support effective vaccine development, especially in low resource settings. This is a one-off funding call and is jointly funded by the Trust and the Coalition for Epidemic Preparedness Innovations (CEPI), an international non-profit association that seeks to develop vaccines to prevent and respond to future epidemics.

Millions of lives are saved each year as a result of vaccination. However, infectious diseases still disproportionately affect those living in parts of Africa and Asia, and new vaccines are needed to tackle both endemic and emerging infectious diseases. Traditional licensed vaccines undergo testing in randomised controlled trials, and can be costly and time consuming to complete. Identification of correlates of protection could significantly reduce the cost and time taken to develop vaccines by serving as alternatives to clinical endpoints, informing earlier go/no-go decisions on which products are likely to meet efficacy endpoints, and guiding clinical trial design where efficacy testing would otherwise be unfeasible. This call wishes to address the barriers currently hampering the discovery and validation of reliable correlates of protection.

There is an urgent need to standardise approaches to develop robust data sets at earlier stages of development. With this call, the aim is to support coordination and collaboration between stakeholders across vaccine development to generate these robust datasets and expand the list of correlates of protection available for vaccine development. The funded research will generate data packages that can support decision-making in vaccine development, including those needed for licensure.

This call is divided into two strands, depending on the disease pathogens studied:

• Part A for bacterial/parasitic diseases, or
• Part B for viral-related diseases.

Through Part A, research will be funded on correlates of protection to support the clinical development or licensure pathway of vaccines against the following diseases:

• Invasive non-typhoidal salmonella, (iNTS)
• Shigella
• Paratyphi A
• Extraintestinal pathogenic E coli (ExPec)
• Group A strep
• Schistosomiasis

In addition, research will be funded through Part B to discover correlates of protection for diseases caused by the following viruses:

• Ebola virus (non-Zaire forms)
• Lassa virus
• Marburg virus
• Nipah virus
• Rift Valley Fever virus

Analysis approaches must be applied to generate harmonised data from relevant sample sets. The samples included may cover: preclinical samples, clinical samples and samples from endemic (disease affected) regions. Sample sets can contain samples from both infected and uninfected individuals and/or from both surviving and non-surviving individuals. Projects must aim to analyse biomarker data in the context of a human vaccine programme.

Proposals may include analysis of existing samples, or collection of new samples as part of a planned or ongoing funded clinical study.