Covid-19 Vaccine Response in Immunocompromised Haematology Patients

NCT04805216 | Completed

• 1 other identifier: 3025
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Haematological Disorders; Immune Suppression

Outcome Measures

Primary Outcomes (6)

• 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

  Duration of Anti-SARS-COV2 IgG antibody response

  120 days follow-up (+/- 7 days) - optional

Secondary Outcomes (11)

• Correlation in antibody response with patient gender

  From recruitment until up to 120 days follow-up (+/- 7 days)

• Correlation in antibody response with patient ethnicity

  From recruitment until up to 120 days follow-up (+/- 7 days)

• Correlation in antibody response with patient haematological disorder

  From recruitment until up to 120 days follow-up (+/- 7 days)

• Correlation in antibody response with patient age

  From recruitment until up to 120 days follow-up (+/- 7 days)

• Correlation in antibody response with patient treatment

  From recruitment until up to 120 days follow-up (+/- 7 days)

Study Arms (2)

Immunocompromised patients (study group)

People who are likely to have a suppressed immunity due to their haematological disorder or its treatment

Procedure: Blood test

Immunocompetent volunteers (control group)

People without suppressed immunity

Procedure: Blood test

Interventions

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): * 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.

Immunocompetent volunteers (control group); Immunocompromised patients (study group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 Immunocompromised haematology patients (also referred to as the "study group") and 30 Immunocompetent, healthy volunteers (also referred to as the "control group")

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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;

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead
• University Hospitals of North Midlands NHS Trust Charity: collaborator
• Staffordshire University: collaborator

Study Sites (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Hematologic Diseases

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 18, 2021
• Study Start: March 15, 2021
• Primary Completion: April 30, 2022
• Study Completion: July 31, 2022
• Last Updated: May 11, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)