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.
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
28,411
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%.
NHS Blood and Transplant
Bristol, United Kingdom
Imperial College
London, United Kingdom
Ipsos Mori
London, United Kingdom
National Disease Registration Service
London, United Kingdom
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Antibodies at 21 - 90 days after 3rd or 4th vaccine
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.