CML-Co-vax: Seroprotection against SARS-CoV-2 in CML patients on TKIs [COVID-19]
Research type
Research Study
Full title
CML-Co-vax: Seroprotection against SARS-CoV-2 in CML patients receiving TKI therapy
IRAS ID
289527
Contact name
Dragana Milojkovic
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
21/SC/0016, REC
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
This study will evaluate the efficacy of the SARS-CoV-2 vaccine in chronic myeloid leukaemia (CML) patients on tyrosine kinase inhibitor (TKI) therapy. It is a prospective study to determine the safety and immunogenicity of the SARS-Cov-2 vaccine in CML patients and healthy controls to characterize the different components of the immune response post vaccination.
The first SARS-Cov-2 vaccine that will be approved by the MHRA and be made available in the NHS will be used for the study. This study does not have an IMP component; vaccination itself is not part of the study as a protocol mandated intervention. Instead, the study will recruit eligible CML patients who are planned to have a SARS-CoV-2 vaccination through the routine NHS care and given according to DoH recommendations to CML patients (Group A) and healthy NHS staff or other healthy individuals (Group B).
In case a second SARS-Cov-2 vaccine receives approval and is made available through the NHS during the course of the study, the investigators may include such patients as well providing they are eligible.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
21/SC/0016
Date of REC Opinion
22 Jan 2021
REC opinion
Further Information Favourable Opinion