ISRCTN12821688进行中（未招募）1 期
Observational Cohort Trial-T-cells Antibodies and Vaccine Efficacy in SARS-CoV-2
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,812
研究概览
简要总结
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)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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