Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Staffordshire University | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunocompromised patients (study group) | People who are likely to have a suppressed immunity due to their haematological disorder or its treatment |
| |
| Immunocompetent volunteers (control group) | People without suppressed immunity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test | Procedure | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation in antibody response with patient gender | 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 |
Not provided
Inclusion Criteria (Immunocompromised Haematology Patients)
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.
Inclusion Criteria (Control group - Immunocompetent Volunteers)
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.
Not provided
Not provided
Not provided
50 Immunocompromised haematology patients (also referred to as the "study group") and 30 Immunocompetent, healthy volunteers (also referred to as the "control group")
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of North Midlands NHS Trust | Stoke-on-Trent | ST4 6QG | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 13, 2025 | |
| Reset | May 29, 2025 | |
| Release | Jun 11, 2025 | |
| Reset | Jun 30, 2025 | |
| Release | Aug 5, 2025 | |
| Reset | Aug 20, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 13, 2025 | May 29, 2025 | |||
| Jun 11, 2025 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
|
Duration of Anti-SARS-COV2 IgG antibody response
| 120 days follow-up (+/- 7 days) - optional |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Duration of T-Cell cytokine response to 2nd dose Covid-19 vaccine | From recruitment and at 60 or 90 days follow-up (+/- 7 days) |
| Jun 30, 2025 |
| Aug 5, 2025 | Aug 20, 2025 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006425 | Hemic and Lymphatic Diseases |