Observational cohort trial of immune response in patients with chronic health conditions following coronavirus vaccinatio

Phase 1

• Registration Number: ISRCTN12821688
• Lead Sponsor: niversity of Birmingham

Brief Summary

2021 Preprint results in https://dx.doi.org/10.2139/ssrn.3910058 (added 31/08/2021) 2023 Results article see attached file ISRCTN12821688_ResultsPlainEnglish_v1.0_10July2023.pdf [1.0] (added 24/07/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37414897/ adult cohorts (added 24/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-17
• Last Update Posted: 7 August 2023
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2812

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>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.