Covid-19 Vaccine Response in Immunocompromised Haematology Patients
- Conditions
- Haematological DisordersCovid19Immune Suppression
- Interventions
- Procedure: Blood test
- Registration Number
- NCT04805216
- Lead Sponsor
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Immunocompetent volunteers (control group) Blood test People without suppressed immunity Immunocompromised patients (study group) Blood test People who are likely to have a suppressed immunity due to their haematological disorder or its treatment
- Primary Outcome Measures
Name Time Method Change in Anti-SARS-COV2 IgG antibodies in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period 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
Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period 120 days follow-up (+/- 7 days) - optional Duration of Anti-SARS-COV2 IgG antibody response
- Secondary Outcome Measures
Name Time Method Correlation in antibody response with patient Covid-19 vaccine type From recruitment until up to 120 days follow-up (+/- 7 days) Covid-19 vaccine type and anti-SARS-Cov-2 IgG antibodies
Correlation in antibody response with patient haematological disorder From recruitment until up to 120 days follow-up (+/- 7 days) Haematological disorder and anti-SARS-Cov-2 IgG antibodies
Correlation in antibody response with patient treatment From recruitment until up to 120 days follow-up (+/- 7 days) Treatment and anti-SARS-Cov-2 IgG antibodies
Correlation in antibody response with patient pre-vaccine immunological parameters From recruitment until up to 120 days follow-up (+/- 7 days) Pre-vaccine immunological parameters and anti-SARS-Cov-2 IgG antibodies
Correlation in antibody response with patient gender From recruitment until up to 120 days follow-up (+/- 7 days) Gender and anti-SARS-Cov-2 IgG antibodies
Correlation in antibody response with patient ethnicity From recruitment until up to 120 days follow-up (+/- 7 days) Ethnicity and anti-SARS-Cov-2 IgG antibodies
T-Cell response after second dose Covid-19 vaccination in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period From recruitment and at 60 or 90 days follow-up (+/- 7 days) T-Cell cytokine response to 2nd dose Covid-19 vaccine
Correlation in antibody response with patient age From recruitment until up to 120 days follow-up (+/- 7 days) Age and anti-SARS-Cov-2 IgG antibodies
Duration of T-Cell response after second dose Covid-19 vaccination in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period From recruitment and at 60 or 90 days follow-up (+/- 7 days) Duration of T-Cell cytokine response to 2nd dose Covid-19 vaccine
PCR positive Covid-19 infections reported by the study group and control group 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)
Adverse events associated with the first and second dose of a Covid-19 vaccination, reported by the study group and control group From recruitment until up to 120 days follow-up (+/- 7 days) Any participant-reported adverse events via baseline CRF
Trial Locations
- Locations (1)
University Hospitals of North Midlands NHS Trust
🇬🇧Stoke-on-Trent, United Kingdom