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

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

DESIGN Observational epidemiological study

AIMS - To determine:

1. 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.
2. 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.

Study Overview

• Status: Completed
• Conditions: Autoimmune Diseases; Haematological Malignancies; Solid Organ Transplant Recipients
• Intervention / Treatment: Diagnostic test: self-administered lateral flow assays

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 28411

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom
    • NHS Blood and Transplant
  • London, United Kingdom
    • Imperial College
  • London, United Kingdom
    • Ipsos Mori
  • London, United Kingdom
    • National Disease Registration Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1. Any adult, or young person over 12 years old, with a functioning transplant who has received at least 3 vaccines, will be eligible to participate.
2. People with rare autoimmune diseases, many of whom are on immunosuppressants, have validated disease diagnoses, and those treated with Rituximab who are most at risk of lack of seroconversion following COVID-19 vaccination.
3. People ≥18 years of age with a haematological malignancy who have received at least 3 vaccines will be eligible.

Description

Inclusion Criteria:

Adults and young people over 12 years of age, and are classified as being part of one of the following patient groups:

1. A solid organ transplant recipient (n=12,000)
2. Patients with a rare autoimmune disease (n=12,000)
3. Patients with lymphoid malignancies (n=12,000) -

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Solid organ transplant patients; 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; 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%.
Rare autoimmune diseases; Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine	Diagnostic test: self-administered lateral flow assays; 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%.
Blood cancer; 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; 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%.

What is the study measuring?

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 participants 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. Reporting of this is delayed following difficulties with collection of data from national bodies.
The Incidence of Participants Hospitalised Due to COVID-19 and Deaths Due to COVID-19	The 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	6-month follow-up period from registration. Reporting of this is delayed following difficulties with collection of data from national bodies.
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

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: University of Nottingham; Nottingham University Hospitals NHS Trust; NHS Blood and Transplant; IPSOS
• Investigators: Principal Investigator: Michelle Willicombe, MBBS, MD, Imperial College London

Publications and helpful links

Helpful Links

• Published results

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Immunosuppression; Covid-19; solid organ transplant; autoimmune disease; SARS-COV-2; Antibody testing; haematological malignancy; blood cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Immune System Diseases; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Autoimmune Diseases
• Other Study ID Numbers: MR/W029200/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No