NCT04805216

Covid-19 Vaccine Response in Immunocompromised Haematology Patients

A Single-centre, Observational Study to Evaluate Immune Response to Covid-19 Vaccines in Immunocompromised Patients With Haematological Disorders

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: University Hospitals of North Midlands NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19
• Haematological Disorders
• Immune Suppression

Interventions

Type	Name	Description
PROCEDURE	Blood test	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.

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-04-30
• Completion: 2022-07-31
• First posted: 2021-03-18
• Last updated: 2023-05-11

Locations

1 site across 1 country: United Kingdom