Covid-19 Vaccine Response in Immunocompromised Haematology Patients (COVAC-IC)

University Hospitals of North Midlands NHS Trust

Status

Completed

Conditions

Covid19

Haematological Disorders

Immune Suppression

Treatments

Procedure: Blood test

Study type

Observational

Funder types

Other

Identifiers

NCT04805216

3025

Details and patient eligibility

About

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 mRNA BNT162b2 vaccine (Pfizer-BioNtech vaccine);
ChAdOx1-S vaccine (Astra Zeneca vaccine);
Covid-19 mRNA vaccine (Moderna vaccine).

Any other Covid-19 vaccines approved for use by the MHRA in immunocompromised and immunocompetent patients are to be included in this study. The above vaccines have received temporary authorisation after placebo-controlled phase 3 studies confirmed their safety and efficacy in over 100,000 volunteers. People who were immunocompromised or were receiving chemotherapy, radiotherapy or immunoglobulin treatment were excluded from these studies. Safety, efficacy, and durability of antibody response in these studies has been assessed for up to 14 weeks only. These vaccines are being rolled out in the UK and have been recommended for use for immunosuppressed individuals including patients undergoing chemotherapy, immunotherapy, radiotherapy, and those who have undergone stem cell transplantation. Though the MHRA has approved vaccination for immunocompromised patients there is no published evidence to confirm safety and efficacy in these patients. The durability of antibody response and whether this is affected by concurrent chemotherapy, immunotherapy, radiotherapy treatment is also unknown.

This observational study aims to evaluate the immune response to Covid-19 vaccines in haematology patients who have immune suppression either due to disease, treatment, or both. The investigators plan to measure Anti-SARS-COV2 IgG antibody levels at 3-5 time points 30 days apart after patients have received their 2nd dose of Covid-19 vaccine. The investigators will also collect any adverse events reported by patient including Covid-19 infection or disease after vaccination.

The study plans to recruit 50 haematology patients who are clinically assessed by a haematologist as immunosuppressed due to their disease, treatment, or both. The study also plans to recruit 30 healthy (immunocompetent) volunteers who would be the control group for comparison of antibody response and durability.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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