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Covid19COVAC-ICNCT04805216

Covid-19 Vaccine Response in Immunocompromised Haematology Patients

An observational study of Covid19 and Haematological Disorders, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 mRNA BNT162b2 vaccine (Pfizer-BioNtech vaccine); ChAdOx1-S vaccine (Astra Zeneca vaccine); Covid-19 mRNA vaccine (Moderna… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Blood test
Type of treatment
Vaccines, Surgery or procedure
How many people
75 participants
Where
1 siteUnited Kingdom
Study dates
15 Mar 2021to 31 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 50 Immunocompromised haematology patients (also referred to as the "study group") and 30 Immunocompetent, healthy volunteers (also referred to as the "control group")

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

About this study

Official title: A Single-centre, Observational Study to Evaluate Immune Response to Covid-19 Vaccines in Immunocompromised Patients With Haematological Disorders

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:

Read more
  • 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.

Being tested
Blood test
Medical subject headings
COVID-19, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood testProcedure or surgery

    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.
Study groups in NCT04805216
Study groupRoleWhat they receive
Immunocompromised patients (study group)People who are likely to have a suppressed immunity due to their haematological disorder or its treatment
Receives: Procedure: Blood test
Immunocompetent volunteers (control group)People without suppressed immunity
Receives: Procedure: Blood test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Anti-SARS-COV2 IgG antibodies in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period

    Anti-SARS-COV2 IgG antibodies

    Measured: Nearest 30 day time point after 2nd dose Covid-19 vaccination (baseline) and every 30 days (3-5 follow-up time points) after 2nd dose of Covid-19 vaccination (+/- 7 days)

  2. Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period

    Duration of Anti-SARS-COV2 IgG antibody response

    Measured: Nearest 30 day time point after 2nd dose Covid-19 vaccination (baseline)

  3. Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period

    Duration of Anti-SARS-COV2 IgG antibody response

    Measured: 30 days follow-up (+/- 7 days)

  4. Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period

    Duration of Anti-SARS-COV2 IgG antibody response

    Measured: 60 days follow-up (+/- 7 days)

  5. Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period

    Duration of Anti-SARS-COV2 IgG antibody response

    Measured: 90 days follow-up (+/- 7 days) - optional

  6. Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period

    Duration of Anti-SARS-COV2 IgG antibody response

    Measured: 120 days follow-up (+/- 7 days) - optional

Secondary outcomes (11)

  1. Correlation in antibody response with patient gender

    Gender and anti-SARS-Cov-2 IgG antibodies

    Measured: From recruitment until up to 120 days follow-up (+/- 7 days)

  2. Correlation in antibody response with patient ethnicity

    Ethnicity and anti-SARS-Cov-2 IgG antibodies

    Measured: From recruitment until up to 120 days follow-up (+/- 7 days)

  3. Correlation in antibody response with patient haematological disorder

    Haematological disorder and anti-SARS-Cov-2 IgG antibodies

    Measured: From recruitment until up to 120 days follow-up (+/- 7 days)

  4. Correlation in antibody response with patient age

    Age and anti-SARS-Cov-2 IgG antibodies

    Measured: From recruitment until up to 120 days follow-up (+/- 7 days)

  5. Correlation in antibody response with patient treatment

    Treatment and anti-SARS-Cov-2 IgG antibodies

    Measured: From recruitment until up to 120 days follow-up (+/- 7 days)

  6. Correlation in antibody response with patient Covid-19 vaccine type

    Covid-19 vaccine type and anti-SARS-Cov-2 IgG antibodies

    Measured: From recruitment until up to 120 days follow-up (+/- 7 days)

  7. Correlation in antibody response with patient pre-vaccine immunological parameters

    Pre-vaccine immunological parameters and anti-SARS-Cov-2 IgG antibodies

    Measured: From recruitment until up to 120 days follow-up (+/- 7 days)

  8. Adverse events associated with the first and second dose of a Covid-19 vaccination, reported by the study group and control group

    Any participant-reported adverse events via baseline CRF

    Measured: From recruitment until up to 120 days follow-up (+/- 7 days)

  9. PCR positive Covid-19 infections reported by the study group and control group

    Patient reported Covid-19 PCR test via CRF, if performed on participant (routine PCR testing is not part of study)

    Measured: From recruitment until up to 120 days follow-up (+/- 7 days, as reported during this time frame)

  10. T-Cell response after second dose Covid-19 vaccination in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period

    T-Cell cytokine response to 2nd dose Covid-19 vaccine

    Measured: From recruitment and at 60 or 90 days follow-up (+/- 7 days)

  11. Duration of T-Cell response after second dose Covid-19 vaccination in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period

    Duration of T-Cell cytokine response to 2nd dose Covid-19 vaccine

    Measured: From recruitment and at 60 or 90 days follow-up (+/- 7 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start15 Mar 2021
  3. Primary completion30 Apr 2022
  4. Study completion31 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04805216
Sponsor's protocol ID
3025
Acronym
COVAC-IC
Status last verified
Feb 2022
First submitted
12 Mar 2021
Last updated
11 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Haematological Disorders, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Anti-SARS-COV2 IgG antibodies in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period (time frame: Nearest 30 day time point after 2nd dose Covid-19 vaccination (baseline) and every 30 days (3-5 follow-up time points) after 2nd dose of Covid-19 vaccination (+/- 7 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04805216.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.

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