Adult groups (18 years or above): patients with end-stage kidney disease, liver disease or gastrointestinal disease on immune suppressive therapy, cancer, immune-mediated rheumatic diseases (e.g. rheumatoid arthritis) and stem cell transplant recipients who are receiving the COVID-19 vaccine as part of the national vaccination programme. Children and adolescents group (aged between 5 and 17 years): patients who are immune-suppressed due to medication following solid organ (heart +/- lung, kidney
Conditions
Interventions
Current interventions as of 08/08/2022:
Three different groups of research samples are being assessed during the trial:
Deep Immunophenotyping Group - each disease cohort will include 150 participant
blood and saliva samples are being collected at 4-5 time points
Serology Group – each disease cohort will include up to 850 participants
blood and saliva samples are being collected twice
Serology Plus Group – comprising three disease cohorts: paediatric cancer, post solid organ transplant and rheumatic/inflammatory conditions
cohorts to include up to 160 participants. Pre- and post-vaccine dose blood samples to be obtained (with a maximum of 4 sample timepoints per participant).
Blood and saliva samples will be collected
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 02/08/2022: 1. Are eligible for vaccination by one of the SARS-CoV-2 vaccines approved by the MHRA administered in accordance with national guidelines and current versions of the applicable information for healthcare professionals (see Section 7.1) and: 1.1. For the Deep Immunotherapy Group only, have not received the second dose of the vaccine (booster) 1.2. For the Serology Group only, have not passed the 28 days (-7/+56 days) post second vaccine dose (booster) 1.3. For the Serology Plus Group, have not passed 28 days (within -7/+56 days) post second vaccine dose (booster) or up to 6 months post second vaccine dose, including patients who have received a third or further dose in that time period 2. Anticipated life expectancy of 6 months or greater 3. Fall into one (or more) of the following patient cohorts who will meet disease relevant classification, disease state, and staging according to established international standards: 3.1. Diagnosed with any of the following malignancies: 3.1.1. Breast 3.1.2. Lung 3.1.3. Acute Myeloid Leukaemia 3.1.4. Multiple Myeloma 3.1.5. Paediatric Cancer: any diagnosis of cancer in a child (aged 5 to < 18 years): 3.1.5.1. On active treatment 3.1.5.2. Within 6 months of completion of treatment 3.2. Diagnosed with the following rheumatic/inflammatory conditions: 3.2.1. Specialist diagnosis of relevant condition 3.2.2. Established on relevant therapy for = 30 days 3.2.3. Meet the definitions in any of the following cohorts: 3.2.3.1. Deep Immunophenotyping Group:: 3.2.3.1.1. Methotrexate plus inflammatory arthritis (to include RA, PsA, seronegative arthritis, and spondyloarthritis) 3.2.3.1.2. TNF inhibitors (any) plus inflammatory arthritis (to include RA, PsA, seronegative arthritis, spondyloarthritis) 3.2.3.1.3. Rituximab in patients with AAV 3.2.3.2. Serology Group: 3.2.3.2.1. Methotrexate plus: 3.2.3.2.1.1. inflammatory arthritis (RA, seronegative arthritis and PsA) 3.2.3.2.1.2. psoriasis 3.2.3.2.2. TNF inhibitors (any) plus: 3.2.3.2.2.1. inflammatory arthritis (RA, seronegative arthritis, axSpA and PsA) 3.2.3.2.2.2. psoriasis 3.2.3.2.2.3. Crohn’s disease 3.2.3.2.3. IL-17 inhibitors (any), IL-12/23 inhibitors and IL-23 inhibitors plus: 3.2.3.2.3.1. seronegative arthritis (PsA and axSpA) 3.2.3.2.3.2. psoriasis 3.2.3.2.4. IL-6 inhibitors (any) with RA 3.2.3.2.5. JAK inhibitors (any) with RA 3.2.3.2.6. Rituximab with RA or AAV 3.2.3.2.7. Any immune modifying treatment with Systemic Lupus Erythematosus (SLE) 3.2.3.3. Serology Plus Group: aged 5 to <18 years at time of recruitment and 3.2.3.3.1. Methotrexate plus inflammatory arthritis with onset under the age of 16 years (also known as juvenile idiopathic arthritis JIA), with or without JIA-uveitis 3.2.3.3.2. TNF inhibitors (any) plus inflammatory arthritis with onset under the age of 16 years (JIA), with or without JIA-uveitis 3.2.3.3.3. IL-6 inhibitors (any) plus inflammatory arthritis with onset under the age of 16 years (JIA), with or without JIA-uveitis 3.2.3.3.4. Any immune modifying treatment with juvenile onset Systemic Lupus Erythematosus (JSLE) 3.2.3.3.5. Rituximab with plus inflammatory arthritis with onset under the age of 16 years (JIA), with or without JIA-uveitis or AAV 3.3. Diagnosed with the following chronic renal conditions: 3.3.1. End stage kidney disease secondary to any cause 3.3.2. Renal transplant following end stage kidney disease 3.4. Diagnosed with the following chronic liver conditions: 3.4.1. Li
Exclusion criteria
Exclusion criteria: Have already received the first dose of the vaccine and have not participated in a study where blood samples taken prior to their first dose of vaccine were stored and are available for analysis in OCTAVE trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Anti-SARS-CoV-2 IgG Abs following vaccination will be measured using the Roche platforms. (The Roche assay measures the presence and amount of serum antibodies to both the spike (S) and the nucleocapsid (N) antigens of SARS-CoV-2. This assay will enable the discrimination of IgG responses to SARS-CoV-2 that results from vaccination and/or SARS-CoV-2 infection) 2. T cell responses to SARS-CoV-2 peptides following vaccination will be measured using the Oxford Immunotec modified T-SPOT Discovery SARS-CoV-2 assay. This IFNg ELISpot assay will provide insights into patient reactivity to SARS-CoV-2 S1, S2, Nucleocapsid and membrane peptides. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured following vaccination: 1. First symptomatic, PCR-proven COVID-19 occurrence from 14 days after first dose of SARS-CoV-2 vaccine in participants without evidence of prior infection with SARS-CoV-2 measured using PCR test 2. Humoral Immunogenicity: SARS-CoV-2 IgG (pseudo)neutralisation assays to assess the capacity of vaccine induced SARS-CoV-2 Abs to neutralise/block SARS-CoV-2 infection Cellular Immunogenicity: 3. The relative contribution of T cell subsets and T cell function will be assessed using intracellular cytokine analysis and flow cytometry (ICCS) - established at Oxford University laboratories 4. Proliferation assays (CTV assay) will evaluate the recall potential of SARS-CoV-2 memory T cells at later (6 month) time points (established at Oxford University laboratories Additional assays relevant to immune state and response may be undertaken: 5. Serum antibodies (IgG/IgM/IgA) to important SARS-CoV-2 antigens and SARS-CoV-2 related antigens (including but not limited to SARS, MERS and circulating seasonal coronaviruses: CoV-2 S, NL63 S, CoV-2 N, CoV-1 S, MERS S, HKU1 S, OC43 S, 229E S, CoV-2 RBD) will be measured in an MSD assay or bespoke ELISA established at University of Glasgow laboratories 6. Saliva antibodies (IgG/IgA) to both the spike (S) and the nucleocapsid (N) antigens of SARS-CoV-2 will be measured using an optimised saliva ELISA 7. Flow cytometric characterisation of the circulating immune compartment (e.g. T cells and B cells) will be undertaken 8. T cell and B cell specific responses to defined peptides/stimuli will be undertaken using established ELISpot assays, at Imperial College London and Oxford University laboratories | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactAnn Pope
Outcome results
None listed