Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04805216
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : June 10, 2021
Sponsor:
Collaborators:
University Hospitals of North Midlands NHS Trust Charity
Staffordshire University
Information provided by (Responsible Party):
University Hospitals of North Midlands NHS Trust

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 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 specified time points until 120 days 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.


Condition or disease Intervention/treatment
Covid19 Haematological Disorders Immune Suppression Procedure: Blood test

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Single-centre, Observational Study to Evaluate Immune Response to Covid-19 Vaccines in Immunocompromised Patients With Haematological Disorders
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

Group/Cohort Intervention/treatment
Immunocompromised patients (study group)
People who are likely to have a suppressed immunity due to their haematological disorder or its treatment
Procedure: Blood test

Participants will have blood tests at baseline (15 - 30 days after 2nd dose of Covid-19 vaccine, +/- 5 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 +/- 5 days:

  • Day 30 (Covid antibody assay) - this test will not be applicable if baseline test performed at day 25-35
  • Day 60 (Covid antibody assay)
  • Day 90 (Covid antibody assay)
  • Day 120 (Covid antibody assay and quantiferon assay)

Immunocompetent volunteers (control group)
People without suppressed immunity
Procedure: Blood test

Participants will have blood tests at baseline (15 - 30 days after 2nd dose of Covid-19 vaccine, +/- 5 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 +/- 5 days:

  • Day 30 (Covid antibody assay) - this test will not be applicable if baseline test performed at day 25-35
  • Day 60 (Covid antibody assay)
  • Day 90 (Covid antibody assay)
  • Day 120 (Covid antibody assay and quantiferon assay)




Primary Outcome Measures :
  1. Change in Anti-SARS-COV2 IgG antibodies in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period [ Time Frame: Within 15-30 days after 2nd dose Covid-19 vaccination (baseline) and 30 days (if applicable), 60 days, 90 days and 120 days after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    Anti-SARS-COV2 IgG antibodies

  2. Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period [ Time Frame: Within 15-30 days after 2nd dose Covid-19 vaccination (baseline) (+/-5 days) ]
    Duration of Anti-SARS-COV2 IgG antibody response

  3. Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period [ Time Frame: 30 days (if applicable) after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    Duration of Anti-SARS-COV2 IgG antibody response

  4. Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period [ Time Frame: 60 days after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    Duration of Anti-SARS-COV2 IgG antibody response

  5. Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period [ Time Frame: 90 days after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    Duration of Anti-SARS-COV2 IgG antibody response

  6. Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period [ Time Frame: 120 days after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    Duration of Anti-SARS-COV2 IgG antibody response


Secondary Outcome Measures :
  1. Correlation in antibody response with patient gender [ Time Frame: From recruitment until 120 days after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    Gender and anti-SARS-Cov-2 IgG antibodies

  2. Correlation in antibody response with patient ethnicity [ Time Frame: From recruitment until 120 days after 1st dose of Covid-19 vaccination (+/- 5 days) ]
    Ethnicity and anti-SARS-Cov-2 IgG antibodies

  3. Correlation in antibody response with patient haematological disorder [ Time Frame: From recruitment until 120 days after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    Haematological disorder and anti-SARS-Cov-2 IgG antibodies

  4. Correlation in antibody response with patient age [ Time Frame: From recruitment until 120 days after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    Age and anti-SARS-Cov-2 IgG antibodies

  5. Correlation in antibody response with patient treatment [ Time Frame: From recruitment until 120 days after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    Treatment and anti-SARS-Cov-2 IgG antibodies

  6. Correlation in antibody response with patient Covid-19 vaccine type [ Time Frame: From recruitment until 120 days after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    Covid-19 vaccine type and anti-SARS-Cov-2 IgG antibodies

  7. Correlation in antibody response with patient pre-vaccine immunological parameters [ Time Frame: From recruitment until 120 days after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    Pre-vaccine immunological parameters and anti-SARS-Cov-2 IgG antibodies

  8. Adverse events associated with the first and second dose of a Covid-19 vaccination, reported by the study group and control group [ Time Frame: Within 15 - 30 days of 2nd dose of Covid-19 vaccination (baseline, +/- 5 days) ]
    Any participant-reported adverse events via baseline CRF

  9. PCR positive Covid-19 infections reported by the study group and control group [ Time Frame: Day 15 to day 120 after 2nd dose of Covid-19 vaccination (as reported during this time frame, +/- 5 days) ]
    Patient reported Covid-19 PCR test via CRF, if performed on participant (routine PCR testing is not part of study)

  10. T-Cell response after second dose Covid-19 vaccination in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period [ Time Frame: Within 15 - 30 days after 2nd dose of Covid-19 vaccination (baseline) and at Day 120 after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    T-Cell cytokine response to 2nd dose Covid-19 vaccine

  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 [ Time Frame: Within 15 - 30 days after 2nd dose of Covid-19 vaccination (baseline) and at Day 120 after 2nd dose of Covid-19 vaccination (+/- 5 days) ]
    Duration of T-Cell cytokine response to 2nd dose Covid-19 vaccine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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")
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 2nd dose of Covid-19 vaccine 10 - 35 days ago (of the screening appointment date);
  • 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;
  • Has had the second dose of Covid-19 vaccine ≥36 days ago (of the screening appointment date);
  • 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 2nd dose of Covid-19 vaccine 10 - 35 days ago (of the screening appointment date);
  • 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 had the second dose of a Covid-19 vaccine ≥36 days ago (of the screening appointment date);
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805216


Contacts
Layout table for location contacts
Contact: Keira Watts 01782 ext 675385 Keira.Watts@uhnm.nhs.uk
Contact: Robert Bowler 01782 ext 671939 Robert.Bowler@uhnm.nhs.uk

Locations
Layout table for location information
United Kingdom
University Hospitals of North Midlands NHS Trust Recruiting
Stoke-on-Trent, United Kingdom, ST4 6QG
Contact: Keira Watts    01782 ext 675385    Keira.Watts@uhnm.nhs.uk   
Contact: Robert Bowler    01782 ext 671939    Robert.Bowler@uhnm.nhs.uk   
Sponsors and Collaborators
University Hospitals of North Midlands NHS Trust
University Hospitals of North Midlands NHS Trust Charity
Staffordshire University
Layout table for additonal information
Responsible Party: University Hospitals of North Midlands NHS Trust
ClinicalTrials.gov Identifier: NCT04805216    
Other Study ID Numbers: 3025
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Hematologic Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases