Clinical trial NCT04805216: Covid-19 Vaccine Response in Immunocompromised Haematology Patients
Official title: A Single-centre, Observational Study to Evaluate Immune Response to Covid-19 Vaccines in Immunocompromised Patients With Haematological Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Haematological Disorders
Immune Suppression
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
Collaborators: name: University Hospitals of North Midlands NHS Trust Charity
name: Staffordshire University
First posted: 2021-03-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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")

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Anti-SARS-COV2 IgG antibodies in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period
timeFrame: 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)
measure: Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period
timeFrame: Nearest 30 day time point after 2nd dose Covid-19 vaccination (baseline)
measure: Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period
timeFrame: 30 days follow-up (+/- 7 days)
measure: Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period
timeFrame: 60 days follow-up (+/- 7 days)
measure: Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period
timeFrame: 90 days follow-up (+/- 7 days) - optional
measure: Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period
timeFrame: 120 days follow-up (+/- 7 days) - optional
Secondary outcomes:
measure: Correlation in antibody response with patient gender
timeFrame: From recruitment until up to 120 days follow-up (+/- 7 days)
measure: Correlation in antibody response with patient ethnicity
timeFrame: From recruitment until up to 120 days follow-up (+/- 7 days)
measure: Correlation in antibody response with patient haematological disorder
timeFrame: From recruitment until up to 120 days follow-up (+/- 7 days)
measure: Correlation in antibody response with patient age
timeFrame: From recruitment until up to 120 days follow-up (+/- 7 days)
measure: Correlation in antibody response with patient treatment
timeFrame: From recruitment until up to 120 days follow-up (+/- 7 days)
measure: Correlation in antibody response with patient Covid-19 vaccine type
timeFrame: From recruitment until up to 120 days follow-up (+/- 7 days)
measure: Correlation in antibody response with patient pre-vaccine immunological parameters
timeFrame: From recruitment until up to 120 days follow-up (+/- 7 days)
measure: Adverse events associated with the first and second dose of a Covid-19 vaccination, reported by the study group and control group
timeFrame: From recruitment until up to 120 days follow-up (+/- 7 days)
measure: PCR positive Covid-19 infections reported by the study group and control group
timeFrame: From recruitment until up to 120 days follow-up (+/- 7 days, as reported during this time frame)
measure: T-Cell response after second dose Covid-19 vaccination in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period
timeFrame: From recruitment and at 60 or 90 days follow-up (+/- 7 days)
measure: Duration of T-Cell response after second dose Covid-19 vaccination in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period
timeFrame: From recruitment and at 60 or 90 days follow-up (+/- 7 days)
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
Study officials:
References: