Immune Responses to COVID-19 vaccination in haem-onc patients [COVID-19]
Research type
Research Study
Full title
COV-VAC Immune Responses to COVID-19 vaccination in patients with haematological disorders.
IRAS ID
294547
Contact name
Emma Morris
Contact email
Sponsor organisation
University College London (UCL) Joint Research Office, part of the Research Directorate
Duration of Study in the UK
1 years, 7 months, 22 days
Research summary
Coronavirus disease 2019 (COVD-19), the disease caused by SARS-CoV-2 has caused over 88 million new cases and 1.9 million deaths as of the 10th January 2021. Patients with malignancies have been identified as having a higher risk of severe disease and death. Vaccines against COVID-19 are essential to reduce disease burden and mortality. Three vaccines (2 mRNA-based candidates and 1 adenoviral vector) have recently published efficacy from large phase III clinical trials and have received emergency authorisation for use in the UK. Vaccines are being rapidly rolled out in the UK prioritising at-risk groups.
Patients with cancer and those receiving treatment for cancer have been shown to have an abnormal response to SARS-CoV-2 infection. The underlying cancer as well as drugs used to treat it can also result in the immune system in these patients being dysfunctional. Whilst vaccines for COVID-19 have been shown to be highly effective in healthy subjects, it is not known how effective they will be in patients with cancer. As cancer patients remain extremely vulnerable to COVID-19 infection, there is an urgent need to understand how patients with cancer respond to COVID-19 vaccination and to determine if they are protected by immunisation.
We intend to conduct a study to assess the immune response to COVID-19 vaccination. We will define the baseline immunological status of the patients before examining whether they are able to produce protective antibodies and a cellular immune response following COVID-19 vaccination. Patients with B-cell malignancies have been demonstrated to have abnormal immune responses to COVID-19 and treatment of their malignancy often results in secondary antibody deficiency thus this group in particular may not mount an antibody response to vaccination. We aim to assess the humoral and cellular responses to SARS-CoV-2 vaccination in this vulnerable group of patients.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0056
Date of REC Opinion
11 Feb 2021
REC opinion
Favourable Opinion