- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04805216
Covid-19 Vaccine Response in Immunocompromised Haematology Patients (COVAC-IC)
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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Stoke-on-Trent, United Kingdom, St4 6QG
- University Hospitals of North Midlands NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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
|
Participants will have blood tests at baseline (nearest 30 day incremental time point after 2nd dose of Covid-19 vaccine, +/- 7 days):
Participants will have blood tests during follow up (after second dose of Covid-19 vaccine) with a window of +/- 7 days:
|
Immunocompetent volunteers (control group)
People without suppressed immunity
|
Participants will have blood tests at baseline (nearest 30 day incremental time point after 2nd dose of Covid-19 vaccine, +/- 7 days):
Participants will have blood tests during follow up (after second dose of Covid-19 vaccine) with a window of +/- 7 days:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Anti-SARS-COV2 IgG antibodies
|
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)
|
Duration of Anti-SARS-COV2 IgG antibody response 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)
|
Duration of Anti-SARS-COV2 IgG antibody response
|
Nearest 30 day time point after 2nd dose Covid-19 vaccination (baseline)
|
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 follow-up (+/- 7 days)
|
Duration of Anti-SARS-COV2 IgG antibody response
|
30 days follow-up (+/- 7 days)
|
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 follow-up (+/- 7 days)
|
Duration of Anti-SARS-COV2 IgG antibody response
|
60 days follow-up (+/- 7 days)
|
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 follow-up (+/- 7 days) - optional
|
Duration of Anti-SARS-COV2 IgG antibody response
|
90 days follow-up (+/- 7 days) - optional
|
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 follow-up (+/- 7 days) - optional
|
Duration of Anti-SARS-COV2 IgG antibody response
|
120 days follow-up (+/- 7 days) - optional
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation in antibody response with patient gender
Time Frame: From recruitment until up to 120 days follow-up (+/- 7 days)
|
Gender and anti-SARS-Cov-2 IgG antibodies
|
From recruitment until up to 120 days follow-up (+/- 7 days)
|
Correlation in antibody response with patient ethnicity
Time Frame: From recruitment until up to 120 days follow-up (+/- 7 days)
|
Ethnicity and anti-SARS-Cov-2 IgG antibodies
|
From recruitment until up to 120 days follow-up (+/- 7 days)
|
Correlation in antibody response with patient haematological disorder
Time Frame: From recruitment until up to 120 days follow-up (+/- 7 days)
|
Haematological disorder and anti-SARS-Cov-2 IgG antibodies
|
From recruitment until up to 120 days follow-up (+/- 7 days)
|
Correlation in antibody response with patient age
Time Frame: From recruitment until up to 120 days follow-up (+/- 7 days)
|
Age and anti-SARS-Cov-2 IgG antibodies
|
From recruitment until up to 120 days follow-up (+/- 7 days)
|
Correlation in antibody response with patient treatment
Time Frame: From recruitment until up to 120 days follow-up (+/- 7 days)
|
Treatment and anti-SARS-Cov-2 IgG antibodies
|
From recruitment until up to 120 days follow-up (+/- 7 days)
|
Correlation in antibody response with patient Covid-19 vaccine type
Time Frame: From recruitment until up to 120 days follow-up (+/- 7 days)
|
Covid-19 vaccine type and anti-SARS-Cov-2 IgG antibodies
|
From recruitment until up to 120 days follow-up (+/- 7 days)
|
Correlation in antibody response with patient pre-vaccine immunological parameters
Time Frame: From recruitment until up to 120 days follow-up (+/- 7 days)
|
Pre-vaccine immunological parameters and anti-SARS-Cov-2 IgG antibodies
|
From recruitment until up to 120 days follow-up (+/- 7 days)
|
Adverse events associated with the first and second dose of a Covid-19 vaccination, reported by the study group and control group
Time Frame: From recruitment until up to 120 days follow-up (+/- 7 days)
|
Any participant-reported adverse events via baseline CRF
|
From recruitment until up to 120 days follow-up (+/- 7 days)
|
PCR positive Covid-19 infections reported by the study group and control group
Time Frame: From recruitment until up to 120 days follow-up (+/- 7 days, as reported during this time frame)
|
Patient reported Covid-19 PCR test via CRF, if performed on participant (routine PCR testing is not part of study)
|
From recruitment until up to 120 days follow-up (+/- 7 days, as reported during this time frame)
|
T-Cell response after second dose Covid-19 vaccination in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period
Time Frame: From recruitment and at 60 or 90 days follow-up (+/- 7 days)
|
T-Cell cytokine response to 2nd dose Covid-19 vaccine
|
From recruitment and at 60 or 90 days follow-up (+/- 7 days)
|
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: From recruitment and at 60 or 90 days follow-up (+/- 7 days)
|
Duration of T-Cell cytokine response to 2nd dose Covid-19 vaccine
|
From recruitment and at 60 or 90 days follow-up (+/- 7 days)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichEnrolling by invitation
-
Alexandria UniversityCompleted
Clinical Trials on Blood test
-
French National Agency for Research on AIDS and...Completed
-
Pascual Gregori RoigHospital Universitario de la Plana; FUNDACIÓN DAVALOS FLETCHERCompletedHyperbilirubinemia, Neonatal | Anemia Neonatal | Polycythemia SecondarySpain
-
Wingate InstituteTel Aviv UniversityCompleted
-
University Hospital, ToursCompleted
-
Cairo UniversityUnknownClass III Malocclusion | Class II Malocclusion
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Imperial College LondonCompletedHereditary Hemorrhagic Telangiectasia | Pulmonary Arteriovenous MalformationsUnited Kingdom
-
Minovia Therapeutics Ltd.RecruitingMyelodysplastic SyndromesIsrael
-
Centre Hospitalier Universitaire de NīmesRecruitingNeoplasm Metastasis | Colorectal Cancer | Disseminated CancerFrance
-
University Hospital, GenevaHospices Civils de LyonNot yet recruitingAbuse, Child | Protein Disorder, BloodFrance, Switzerland