Vaccine responses in ANCA associated vasculitis

Phase 1

• Conditions: Pneumococcal vaccine responses in ANCA associated vasculitis; MedDRA version: 20.1 Level: PT Classification code 10050894 Term: Anti-neutrophil cytoplasmic antibody positive vasculitis System Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-003563-36-GB
• Lead Sponsor: Cambridge University Hospital NHS Foundation Trust and University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 124

Inclusion Criteria

To be included in the trial all participants must:
•Have given written informed consent to participate
•Be aged 40 years and over

For patients in Group 1 only (rituximab treated):

•Have a diagnosis of AAV [granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) or eosinophilic granulomatosis with polyangiitis (eGPA)]
•Have current or historical PR3/MPO ANCA positivity by ELISA or histological confirmation of AAV
•Have received = 2g rituximab
•Have received their last dose of rituximab at least 12 months prior to enrolment
•Be in stable remission with a prednisolone dose of = 5mg/day

For patients in Group 2 only (disease controls who have never received rituximab):

•Have a diagnosis of AAV (GPA, MPA or eGPA)
•Have current or historical PR3/MPO ANCA positivity by ELISA or histological confirmation of AAV
•Have received cyclophosphamide (oral or IV) as initial induction therapy
•Be on stable immunosuppression for the 6 months preceding screening including prednisolone = 5mg/day AND either azathioprine, methotrexate or mycophenolate mofetil (at stable or tapering dose)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

The presence of any of the following will preclude participant inclusion:

•Age < 40 years
•History of severe allergic or anaphylactic reactions to pneumococcal vaccinations including excipients and diptheria toxoid.
•Pneumococcal vaccination within 5 years prior to screening
•Females who are pregnant, plan to become pregnant, or breast feeding
•Medical, psychiatric, cognitive or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, give informed consent, comply with the trial protocol, or to complete the study.
•History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure.
•Replacement immunoglobulin (IVIg) administered intravenously or subcutaneously in the 12 weeks prior to screening visit.

For patients in Groups 1 and 2 only (AAV patients):

•Presence of another multisystem autoimmune rheumatic disease
•The prior receipt of more than 36g of cumulative cyclophosphamide ever (either IV or oral)

For patients in group 1 only (rituximab group)

•The receipt of any immune suppressing agent (azathioprine, methotrexate or mycophenolate mofetil) after rituximab

For patients in Group 2 only (disease controls):

•A relapse of AAV within the 6 months prior to screening which has necessitated an increase in prednisolone or azathioprine, methotrexate or MMF dose.
•Previous rituximab therapy at any time

For healthy controls:

•Any history of any autoimmune condition
•Any history of use of immune suppressing medication, including > 4 weeks of oral glucocorticoids, within the 5 years prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified