Covid-19 Vaccine Response in Immunocompromised Haematology Patients

Covid19 Clinical Trial

— COVAC-IC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805216
• Other study ID #: 3025
• Status: Completed
• Start date: March 15, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2022
• Source: University Hospitals of North Midlands NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Immunocompromised Haematology Patients)

• 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.

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.

• Ineligible for health reasons and/or as per Government prioritisation of vaccinations

Inclusion Criteria (Control group - Immunocompetent Volunteers)

• 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.

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.

• Ineligible for health reasons and/or as per Government prioritisation of vaccinations

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Haematological Disorders
• Hematologic Diseases
• Immune Suppression

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent

Sponsors (3)

Lead Sponsor	Collaborator
University Hospitals of North Midlands NHS Trust	Staffordshire University, University Hospitals of North Midlands NHS Trust Charity

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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	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)
Secondary	Correlation in antibody response with patient ethnicity	Ethnicity and anti-SARS-Cov-2 IgG antibodies	From recruitment until up to 120 days follow-up (+/- 7 days)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)