Covid-19 Vaccine Response in Immunocompromised Haematology Patients
NCT ID: NCT04805216
Last Updated: 2023-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2021-03-15
2022-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Immunocompromised patients (study group)
People who are likely to have a suppressed immunity due to their haematological disorder or its treatment
Blood test
Participants will have blood tests at baseline (nearest 30 day incremental time point after 2nd dose of Covid-19 vaccine, +/- 7 days):
* T, B \& NK cells
* Full Blood Count and differential
* Serum Immunoglobulins
* Antibodies against VZV, CMV, Rubella
* Quantiferon assay (T-Cell response)
* Covid antibody assay (LIAISON® SARS-CoV-2 S1/S2 IgG quantitative assay)
Participants will have blood tests during follow up (after second dose of Covid-19 vaccine) with a window of +/- 7 days:
* Blood test 2 - performed at the next 30 day time point (Covid antibody assay)
* Blood test 3 - performed at the next 30 day time point (Covid antibody assay and quantiferon\* if final blood test)
* Blood test 4 (optional) - performed at the next 30 day time point (Covid antibody assay)
* Blood test 5 (optional) - performed at the next 30 day time point (Covid antibody assay and quantiferon\* if final blood test)
* Quantiferon assay will be only be performed where possible.
Immunocompetent volunteers (control group)
People without suppressed immunity
Blood test
Participants will have blood tests at baseline (nearest 30 day incremental time point after 2nd dose of Covid-19 vaccine, +/- 7 days):
* T, B \& NK cells
* Full Blood Count and differential
* Serum Immunoglobulins
* Antibodies against VZV, CMV, Rubella
* Quantiferon assay (T-Cell response)
* Covid antibody assay (LIAISON® SARS-CoV-2 S1/S2 IgG quantitative assay)
Participants will have blood tests during follow up (after second dose of Covid-19 vaccine) with a window of +/- 7 days:
* Blood test 2 - performed at the next 30 day time point (Covid antibody assay)
* Blood test 3 - performed at the next 30 day time point (Covid antibody assay and quantiferon\* if final blood test)
* Blood test 4 (optional) - performed at the next 30 day time point (Covid antibody assay)
* Blood test 5 (optional) - performed at the next 30 day time point (Covid antibody assay and quantiferon\* if final blood test)
* Quantiferon assay will be only be performed where possible.
Interventions
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Blood test
Participants will have blood tests at baseline (nearest 30 day incremental time point after 2nd dose of Covid-19 vaccine, +/- 7 days):
* T, B \& NK cells
* Full Blood Count and differential
* Serum Immunoglobulins
* Antibodies against VZV, CMV, Rubella
* Quantiferon assay (T-Cell response)
* Covid antibody assay (LIAISON® SARS-CoV-2 S1/S2 IgG quantitative assay)
Participants will have blood tests during follow up (after second dose of Covid-19 vaccine) with a window of +/- 7 days:
* Blood test 2 - performed at the next 30 day time point (Covid antibody assay)
* Blood test 3 - performed at the next 30 day time point (Covid antibody assay and quantiferon\* if final blood test)
* Blood test 4 (optional) - performed at the next 30 day time point (Covid antibody assay)
* Blood test 5 (optional) - performed at the next 30 day time point (Covid antibody assay and quantiferon\* if final blood test)
* Quantiferon assay will be only be performed where possible.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University Hospitals of North Midlands NHS Trust Charity
UNKNOWN
Staffordshire University
OTHER
University Hospitals of North Midlands NHS Trust
OTHER
Responsible Party
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Locations
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University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, , United Kingdom
Countries
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Other Identifiers
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3025
Identifier Type: -
Identifier Source: org_study_id
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