COBALT CHILD
Research type
Research Study
Full title
COvid-19 vaccination and Biomarkers in cirrhosis And post-Liver transplantation In Children (COBALT- CHILD)
IRAS ID
313697
Contact name
Gautam Mehta
Contact email
Sponsor organisation
European Foundation for the Study of Chronic Liver Failure (EF-CLIF)
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The aim of this research is to study the effect of vaccination against Covid-19. Patients with liver disease have been shown to have worse outcomes from Covid-19. Additionally, we are unsure if patients with liver disease, or those with a liver transplant, have the same responses to vaccination as other ‘healthy’ individuals because these patients were not included in most clinical trials of the vaccines. Therefore, the overall aim is to see if liver disease and liver transplant patients respond as well to vaccination as healthy individuals, in terms of antibody responses as well as clinical outcomes in the 12 months following vaccination.
This study has been extended to paediatric population where patients at Birmingham Children's Hospital who have are ≥ 1 year after paediatric liver transplantation, ≥ 1 year after paediatric kidney transplantation, compensated chronic liver disease and autoimmune liver disease will be recruited. The study will involve blood samples being taken from participants on a maximum of three occasions over 32 weeks, around their Covid-19 vaccination appointments. These samples will be analysed for levels of anti-coronavirus (SARS-CoV-2) antibodies, which is a marker of 'successful' vaccination. These levels in liver disease or post-transplant patients will be compared with those in healthy participants. Additionally, participants will be asked to complete a symptom diary for the 14 days following their Covid-19 vaccinations, to see if there is a difference in side-effects from vaccination in liver disease or post-transplant compared to healthy participants.
The study in total will continue for 20 months. We aim to complete recruitment of participants within 6 months, but also continue data collection for hospitalisations up to 12 months following Covid-19 vaccination. We will require a further 2 months to collect this data for the 12 month period.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
22/LO/0419
Date of REC Opinion
16 Jun 2022
REC opinion
Unfavourable Opinion