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
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.
Summary of Results:
1.
We looked at how well people with chronic myeloid leukaemia (CML) on Tyrosine kinase inhibitors ( TKIs) responded to COVID-19 vaccines, as there was a concern that either the CML or the TKI may cause additional immunosuppression. These data were very informative as they would be able to guide patients and doctors on how to manage and advise patients during the COVID pandemic. In parallel , the data would provide information on how immunosuppressive TKIs were in general.
The study found that most CML patients produced good levels of antibodies, or immune response, after their second COVID-19 vaccine dose, providing protection. Importantly, antibody levels persisted for some time after vaccination, allowing for a durable immune response. In summary , we found that patients with CML who are taking TKI treatment can still develop strong and lasting protection from COVID-19 vaccination, similar to people without this condition.2.
Similarly, we evaluated 62 people with CML on TKI and compared them with 44 people without CML. Participants received two COVID-19 vaccine doses and then a booster (third dose).Immune responses were measure by assessing antibody levels, T-cells, and memory B cells after vaccination. This study found that CML patients produced immune responses similar to healthy people and the booster dose significantly increased immunity, especially T-cell responses as well as against the Omicron COVID-19 variant.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