Evaluation of T Cell Dysfunction in Post Acute Infection Syndromes
Research type
Research Study
Full title
Study to Evaluate the Role of T Cell Dysfunction in Symptoms Associated with Long COVID, Lyme Disease and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) using the ViraxImmune FluoroSpot T Cell Assay
IRAS ID
342415
Contact name
Nigel McCracken
Contact email
Sponsor organisation
Virax Biolabs
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Post acute infection syndromes (PAISs) is a term used to describe complex conditions like long COVID (LC), Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and post treatment Lyme disease (PTLD) that are characterized by persistent symptoms once an initial infection has been cleared from the body. Factors thought to play a role in these conditions include ongoing inflammation and an over active immune system. For patients, the symptoms can be debilitating and impact on their quality of life. Unfortunately, there are currently no reliable diagnostic tests that can be used to identify these conditions.
A longitudinal cohort study will be conducted where individuals with persistent symptoms associated with diagnosed long COVID, ME/CFS and Lyme disease will be recruited and seen at two time points (study entry and at 6 months post study entry). At each time point participants will be asked to complete a questionnaire relating to the symptoms they experience and provide a blood sample. A control group of healthy individuals who are not experiencing symptoms of chronic illness will be recruited as a comparator group .
The cells of the immune system called ‘Peripheral blood mononuclear cells’ (PBMCs) will be separated from the blood sample and used to test a new assay (diagnostic test) that can quantify the immune system response in individual patients. The intention of this study is to collect data that helps development of a diagnostic test for early diagnosis of post acute infection syndromes. This would hopefully speed up appropriate clinical management and improve patient outcomes and patient quality of life. .
Participants will need to be aged 18 years and above. Where a participant is unable to attend a clinic (a number of patients in the study cohorts may be house-bound) to have a blood sample taken, a home visit will be arranged. It is anticipated the study will last for a period of 12 months or until 160 eligible participants have been recruited.REC name
West of Scotland REC 4
REC reference
24/WS/0148
Date of REC Opinion
19 Nov 2024
REC opinion
Further Information Favourable Opinion