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 Type
OBSERVATIONAL
Enrollment
75
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.
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
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
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)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Duration of Anti-SARS-COV2 IgG antibody response
Time frame: 120 days follow-up (+/- 7 days) - optional
Correlation in antibody response with patient gender
Gender and anti-SARS-Cov-2 IgG antibodies
Time frame: From recruitment until up to 120 days follow-up (+/- 7 days)
Correlation in antibody response with patient ethnicity
Ethnicity and anti-SARS-Cov-2 IgG antibodies
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From recruitment and at 60 or 90 days follow-up (+/- 7 days)