COVID-19 Cellular Immunity Test [COVID-19]

  • Research type

    Research Study

  • Full title

    Validation and longitudinal assessment of a SARS-CoV-2 (COVID-19) T cell immunity test

  • IRAS ID

    294246

  • Contact name

    Martin Scurr

  • Contact email

    martinscurr@immunoserv.com

  • Sponsor organisation

    ImmunoServ Ltd

  • Clinicaltrials.gov Identifier

    Immunity Programme, Health Data Research UK - COVID-19 National Core Study

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    As the current COVID-19 pandemic unfolds, we urgently require screening tools that determine who is sufficiently protected from the SARS-CoV-2 virus, which causes the disease. To enable the population and the economy to return to normal, it is important to know who has become immune to the virus through infection or vaccination.

    In order to gain immunity to SARS-CoV-2, an individual must generate an adequate immune response that protects from future infection. This can be measured by looking for antibodies found in blood samples that bind specifically to the virus. Unfortunately, antibody responses naturally wane over time, and there are now many instances where COVID-19-positive individuals no longer have detectable antibodies. However, long-term protection against viruses not only comes from antibodies, but from cells of the immune system called 'T cells', which play a critical role in controlling and eradicating viral infections. There is an increasing acceptance amongst immunologists that a T cell response is longer lasting and must be present to constitute effective, protective immunity. The magnitude and durability of a T cell response that protects against reinfection remains unknown, but is an area of fervent international interest.

    Ordinarily, techniques that measure T cell responses are laborious, hard to standardise, expensive and labour-intensive. This project will establish a high- throughput, laboratory-based assay that identifies the presence of SARS-CoV-2- reactive T cells from a single tube of blood. A simple, effective measurement of an individual's T cell response to SARS-CoV-2 would revolutionise our understanding of what constitutes protective immunity to COVID-19. In addition, as vaccines are rolled out, results from the test developed here will yield critical additional information as to whether an adequate immune response that protects individuals from SARS-CoV-2 infection has been generated. This product would enable large scale T cell immunity testing to be performed, crucial for assessing population immunity, monitoring vaccine efficacy, and more broadly resuming a normal lifestyle.

  • REC name

    North East - Newcastle & North Tyneside 2 Research Ethics Committee

  • REC reference

    21/NE/0036

  • Date of REC Opinion

    9 Feb 2021

  • REC opinion

    Further Information Favourable Opinion