Clinical trial NCT05148806: Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 (Covid-19) Antibodies
Official title: Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 Antibody Responses in Immunosuppressed People (The MELODY Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Organ Transplant Recipients
Autoimmune Diseases
Haematological Malignancies
Keywords: Antibody testing
SARS-COV-2
Covid-19
Immunosuppression
solid organ transplant
haematological malignancy
blood cancer
autoimmune disease
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: NHS Blood and Transplant
name: IPSOS
name: University of Nottingham
name: Nottingham University Hospitals NHS Trust
First posted: 2021-12-08
Enrollment: 28411
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: The Proportion of Participants With and Without Antibodies to SARS-CoV-2
timeFrame: 21 - 90 days post 3rd vaccine
measure: The Proportion of Participants With and Without Antibodies to SARS-CoV-2
timeFrame: 21 - 90 days post 4th vaccine
measure: The Incidence of Participants Having at Least One RT-qPCR Proven Infection in the 6-month Follow-up Period After 3rd or 4th Vaccine
timeFrame: 6-month follow-up period from registration. Reporting of this is delayed following difficulties with collection of data from national bodies.
measure: The Incidence of Participants Hospitalised Due to COVID-19 and Deaths Due to COVID-19
timeFrame: 6-month follow-up period from registration. Reporting of this is delayed following difficulties with collection of data from national bodies.
measure: Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine
timeFrame: Antibodies at 21 - 90 days after 3rd or 4th vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: NHS Blood and Transplant
city: London
country: United Kingdom
facility: Imperial College
city: London
country: United Kingdom
facility: Ipsos Mori
city: London
country: United Kingdom
facility: National Disease Registration Service
Study officials:
affiliation: Imperial College London
name: Michelle Willicombe, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: