Autoimmune Diseases, Haematological Malignancies, Solid Organ Transplant Recipients
Conditions
Keywords
Antibody testing, SARS-COV-2, Covid-19, Immunosuppression, solid organ transplant, haematological malignancy, blood cancer, autoimmune disease
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.
Interventions
DIAGNOSTIC_TESTself-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%.
Sponsors
NHS Blood and Transplant
IPSOS
University of Nottingham
Nottingham University Hospitals NHS Trust
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | 21 - 90 days post 3rd vaccine | 1\. The proportion of with and without antibodies to SARS-CoV-2 at 21 - 90 days post three vaccine doses will be presented. |
| The Incidence of Participants Having at Least One RT-qPCR Proven Infection in the 6-month Follow-up Period 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 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. |
| The Incidence of Participants Hospitalised Due to COVID-19 and Deaths Due to COVID-19 | 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 by 6 months will be presented for those with and without antibodies to SARS-CoV-2 following 3rd or 4th vaccine |
| Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibodies at 21 - 90 days 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Solid Organ Transplant Patients Patients who have received a solid organ transplant and who have received at least 3 doses of Covid-19 vaccine
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%. | 9,927 |
| Rare Autoimmune Diseases Patients with a rare autoimmune disease who have received at least 3 doses of Covid-19 vaccine
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%. | 6,516 |
| Blood Cancer-Lymphoid Malignancy Patients with acute myeloid and lymphoid blood cancers who have received at least 3 doses of Covid-19 vaccine.
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%. | 6,593 |
| Total | 23,036 |
Baseline characteristics
| Characteristic | Total | Blood Cancer-Lymphoid Malignancy | Rare Autoimmune Diseases | Solid Organ Transplant Patients |
|---|---|---|---|---|
| Age, Continuous | NA years | 59 years | 62 years | 60 years |
| Race/Ethnicity, Customized Asian | 655 Participants | 73 Participants | 231 Participants | 351 Participants |
| Race/Ethnicity, Customized Black | 302 Participants | 38 Participants | 130 Participants | 134 Participants |
| Race/Ethnicity, Customized Not reported | 79 Participants | 17 Participants | 21 Participants | 41 Participants |
| Race/Ethnicity, Customized Other | 339 Participants | 64 Participants | 142 Participants | 133 Participants |
| Race/Ethnicity, Customized White | 21661 Participants | 6401 Participants | 5992 Participants | 9268 Participants |
| Region of Enrollment United Kingdom | 23036 participants | 6593 participants | 6516 participants | 9927 participants |
| Sex: Female, Male Gender Female | 12535 Participants | 2971 Participants | 5070 Participants | 4494 Participants |
| Sex: Female, Male Gender Male | 10485 Participants | 3620 Participants | 1439 Participants | 5426 Participants |
| Total number of vaccines at time of test 3 vaccines | 6583 Participants | 1268 Participants | 2615 Participants | 2700 Participants |
| Total number of vaccines at time of test 4 vaccines | 14234 Participants | 4657 Participants | 3531 Participants | 6046 Participants |
| Total number of vaccines at time of test 5+ vaccines | 2219 Participants | 668 Participants | 370 Participants | 1181 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9,927 | 0 / 6,516 | 0 / 6,593 |
| other Total, other adverse events | 0 / 9,927 | 0 / 6,516 | 0 / 6,593 |
| serious Total, serious adverse events | 0 / 9,927 | 0 / 6,516 | 0 / 6,593 |
Outcome results
Primary
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
Population: After 3rd or 4th vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solid Organ Transplant Patients | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Negative after 3 vaccines | 875 participants who received vaccines |
| Solid Organ Transplant Patients | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Positive after 3 vaccines | 1825 participants who received vaccines |
| Solid Organ Transplant Patients | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Negative after 4 vaccines | 1242 participants who received vaccines |
| Solid Organ Transplant Patients | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Positive after 4 vaccines | 4804 participants who received vaccines |
| Solid Organ Transplant Patients | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Negative after 5+ vaccines | 193 participants who received vaccines |
| Solid Organ Transplant Patients | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Positive after 5+ vaccines | 988 participants who received vaccines |
| Rare Autoimmune Diseases | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Positive after 5+ vaccines | 333 participants who received vaccines |
| Rare Autoimmune Diseases | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Negative after 3 vaccines | 378 participants who received vaccines |
| Rare Autoimmune Diseases | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Positive after 4 vaccines | 3024 participants who received vaccines |
| Rare Autoimmune Diseases | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Negative after 5+ vaccines | 37 participants who received vaccines |
| Rare Autoimmune Diseases | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Positive after 3 vaccines | 2237 participants who received vaccines |
| Rare Autoimmune Diseases | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Negative after 4 vaccines | 507 participants who received vaccines |
| Blood Cancer | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Positive after 3 vaccines | 991 participants who received vaccines |
| Blood Cancer | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Negative after 4 vaccines | 1006 participants who received vaccines |
| Blood Cancer | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Positive after 5+ vaccines | 585 participants who received vaccines |
| Blood Cancer | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Positive after 4 vaccines | 3651 participants who received vaccines |
| Blood Cancer | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Negative after 3 vaccines | 277 participants who received vaccines |
| Blood Cancer | Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine | Antibody Negative after 5+ vaccines | 83 participants who received vaccines |
Primary
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.
Primary
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.
Primary
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
Population: Patients who have received 4 vaccines
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Solid Organ Transplant Patients | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | Antibody Negative | 1242 Participants |
| Solid Organ Transplant Patients | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | Antibody Positive | 4804 Participants |
| Rare Autoimmune Diseases | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | Antibody Negative | 507 Participants |
| Rare Autoimmune Diseases | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | Antibody Positive | 3024 Participants |
| Blood Cancer | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | Antibody Negative | 1006 Participants |
| Blood Cancer | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | Antibody Positive | 3651 Participants |
Primary
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
Population: Patients who have received 3 vaccines
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Solid Organ Transplant Patients | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | Antibody Negative | 875 Participants |
| Solid Organ Transplant Patients | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | Antibody Positive | 1825 Participants |
| Rare Autoimmune Diseases | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | Antibody Negative | 378 Participants |
| Rare Autoimmune Diseases | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | Antibody Positive | 2237 Participants |
| Blood Cancer | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | Antibody Negative | 277 Participants |
| Blood Cancer | The Proportion of Participants With and Without Antibodies to SARS-CoV-2 | Antibody Positive | 991 Participants |