10008511Development and validation of an easily accessible, whole-blood test for the assessment of natural and vaccine-induced T-cell responses to SARS-CoV-2ClosedSmall Business Research InitiativeInnovate UKWith the role out of the SARS-CoV-2 vaccination programme here in the UK well underway, questions around the efficacy and the longevity of these vaccines are beginning to be asked. The aim of vaccinations is to produce a robust, long lived immune response, thus preventing re-infection in the wider population. The production of antibodies is one way the body can fight viral infections. Additionally, long-term protection also comes from T-cells, which play a critical role in controlling and eradicating the virus. However, little is known about the longevity of the T-cell response generated from vaccinations. Therefore, our goal is to develop a novel T-cell test that will contribute to addressing some fundamental research questions such as if immunity will begin to wane after a defined time, and will differences in magnitude or longevity of these response be observed in vulnerable cohorts within the wider population? Historically, measuring T-cell immune responses to viruses has proved a more difficult task than measuring virus-specific antibodies as they are laborious and require complex technical know-how. Here, we propose using a novel system that is designed to overcome the technical hurdles and time constraints associated with traditional methods. We aim to make disruptive innovations in terms of obtaining samples from patients, leading to improved accessibility to the test by validating novel methods of blood collection that would abrogate the requirement for venous blood draw from a trained phlebotomist. From this one sample of blood, we would then stimulate T-cells found within that sample and measure the subsequent production of cytokines - proteins that form a crucial part of the immune system that aids with eradicating the virus. Our intention is to trial the test in a clinical setting, wherein we will measure T-cell responses in cohorts of individuals deemed to be clinically vulnerable or most 'at risk' from re-infection. These will include HIV-infected patients, immunocompromised patients, and vaccine non-responders. Our test would measure T-cell responses over time to assess if T-cell immunity wanes faster in these cohorts of individuals. If successful, our ambition is to be able to commercialise the test and offer it on a wider scale. In collaboration with experts in the virology field from academia and experienced clinicians and GPs from the NHS, we are confident on delivering this innovative and highly sort after T-cell test.