Status:
COMPLETED
Covid-19 Vaccine Response in Immunocompromised Haematology Patients
Lead Sponsor:
University Hospitals of North Midlands NHS Trust
Collaborating Sponsors:
University Hospitals of North Midlands NHS Trust Charity
Staffordshire University
Conditions:
Covid19
Haematological Disorders
Eligibility:
All Genders
18+ years
Brief Summary
The UK Medicine and Healthcare products Regulatory Agency (MHRA) granted temporary authorisation to three Covid-19 vaccines in December 2020 and January 2021. These vaccinations include: * Covid-19 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Immunocompromised Haematology Patients)
- Aged 18 years and over;
- Has one or more haematological disorder(s) with compromised immunity or currently receiving or recently treated (within previous 3 months of the screening appointment date) with immunosuppressive therapy, chemotherapy, radiotherapy or stem cell transplantation;
- Has had at least 2 doses of Covid-19 vaccine;
- Willing and able to give fully informed consent;
- Willing and able to comply with the study procedures;
- Anticipated life expectancy of over 6 months.
- Exclusion Criteria (Immunocompromised Haematology Patients)
- Has declined or does not wish to have Covid-19 vaccine;
- Is receiving regular IV Immunoglobulins for immunodeficiency;
- Is taking part in an interventional Covid-19 vaccine study;
- Ineligible\* for Covid-19 vaccine;
- Non-English speaker where translation facilities are insufficient to guarantee informed consent.
- Ineligible for health reasons and/or as per Government prioritisation of vaccinations
- Inclusion Criteria (Control group - Immunocompetent Volunteers)
- Aged 18 years and over;
- Is immunocompetent;
- Has had at least 2 doses of Covid-19 vaccine;
- Anticipated life expectancy of over 6 months;
- Willing and able to give fully informed consent;
- Willing and able to comply with the study procedures.
- Exclusion Criteria (Control group - Immunocompetent Volunteers)
- Has declined or does not wish to have Covid-19 vaccine;
- Has comorbidity known to result in immune suppression;
- Has received treatment (within previous 12 months of the screening appointment) with immunosuppressive therapy, chemotherapy, radiotherapy or stem cell transplantation;
- Is taking part in an interventional Covid-19 vaccine study;
- Ineligible for Covid-19 vaccine\*;
- Non-English speaker where translation facilities are insufficient to guarantee informed consent.
- Ineligible for health reasons and/or as per Government prioritisation of vaccinations
Exclusion
Key Trial Info
Start Date :
March 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04805216
Start Date
March 15 2021
End Date
July 31 2022
Last Update
May 11 2023
Active Locations (1)
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1
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom, ST4 6QG