Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 (Covid-19) Antibodies

Study Overview
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Brief Summary
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DESIGN Observational epidemiological study AIMS - To determine: The proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the demographic, disease, and treatment characteristics that influence antibody status. If the detection of antibodies inversely correlates with subsequent risk of severe acute respiratory syndrome coronavirus-2 infection and/or severity of disease in immunosuppressed people.

Detailed Description
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The aim of this proposal is to assess at a population level; 1) the proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the sociodemographic, disease, and treatment characteristics that influence antibody status; 2) if the detection of antibodies inversely correlates with subsequent risk of SARS-CoV2 infection and/or severity of disease in immunosuppressed individuals. The investigators aim to target patient groups least likely to mount an immune response to vaccination; a) solid organ transplant recipients; b) patients with a rare autoimmune disease c) patients with haematological malignancies, specifically lymphoid malignancies. The investigators will use comprehensive registries to identify and recruit patients from these groups, and utilise the existing linkages these registries already have to obtain COVID-19 outcome information. The investigators hypothesise that a sizeable proportion of immunosuppressed people will have no detectable SARS-CoV-2 antibodies following a three vaccine doses, and that this cohort is particularly susceptible to SARS-CoV-2 infection and death.

Official Title
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Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 Antibody Responses in Immunosuppressed People (The MELODY Study)

Conditions
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Solid Organ Transplant Recipients, Autoimmune Diseases, Haematological Malignancies

Intervention / Treatment
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* Diagnostic Test: self-administered lateral flow assays


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults and young people over 12 years of age, and are classified as being part of one of the following patient groups: A solid organ transplant recipient (n=12,000) Patients with a rare autoimmune disease (n=12,000) Patients with lymphoid malignancies (n=12,000) - Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Solid organ transplant patients<br>Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine | Diagnostic Test: self-administered lateral flow assays<br>* The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%.<br>|
| Rare autoimmune diseases<br>Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine | Diagnostic Test: self-administered lateral flow assays<br>* The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%.<br>|
| Blood cancer<br>Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine. | Diagnostic Test: self-administered lateral flow assays<br>* The lateral flow device to be used is the Fortress COVID-19 Total Antibody Device for the detection of IgM and IgG SARS-CoV-2 against the spike protein. The device has been evaluated for use in detecting anti-S in transplant patients and found to have a sensitivity of 92% and specificity of 95%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of participants with and without antibodies to SARS-CoV-2 | 1. The proportion of with and without antibodies to SARS-CoV-2 at 21 - 90 days post three vaccine doses will be presented. | 21 - 90 days post 3rd vaccine | 
| The proportion of participants with and without antibodies to SARS-CoV-2 | 1. The proportion of with and without antibodies to SARS-CoV-2 at 21 - 90 days post four vaccine doses will be presented. | 21 - 90 days post 4th vaccine | 
| The incidence of participants having at least one RT-qPCR proven infection in the 6-month follow-up period after 3rd or 4th vaccine | The incidence of participants having at least one RT-qPCR proven infection in the 6-month follow-up will be presented for those with and without antibodies to SARS-CoV-2 after 3rd or 4th vaccine. | 6-month follow-up period from registration | 
| The incidence of participants hospitalised due to COVID-19 and deaths due to COVID-19 by 6 months. | Incidence of participants hospitalised due to COVID-19 and deaths due to COVID-19 by 6 months will be presented for those with and without antibodies to SARS-CoV-2 following 3rd or 4th vaccine, and compared as described above if there are sufficient events. | 6 month follow-up period from registration | 
| Rates of those with and without antibodies to SARS-CoV-2 after 3rd or 4th vaccine | Rates of those with and without antibodies to SARS-CoV-2 after 3rd or 4th vaccine will be presented for different clinical characteristics and sociodemographic factors. | Antibodies at 21 - 90 days after 3rd or 4th vaccine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibody testing, SARS-COV-2, Covid-19, Immunosuppression, solid organ transplant, haematological malignancy, blood cancer, autoimmune disease