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Acquired Immunodeficiency in ANCA Associated Vasculitis

NCT03514979 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2018-05-03

No results posted yet for this study

Summary

This study will address the following hypothesis: Rituximab therapy leads to an acquired immune deficiency, as demonstrated by impaired vaccine responses, in AAV patients.

Aims:

1. To investigate whether rituximab leads to immune deficiency in patients with AAV when compared to both disease and healthy controls.
2. To investigate whether the degree of immune deficiency is associated with the degree of B cell depletion.
3. To investigate whether T-independent vaccine responses are more severely affected than T-dependent vaccine responses after rituximab and whether a conjugated vaccine will overcome this postulated deficit in T independent vaccine responses.

Conditions

  • Systemic Vasculitis

Interventions

BIOLOGICAL

Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide Vaccination

Pneumococcal vaccines

Sponsors & Collaborators

  • Arthritis Research UK

    collaborator OTHER

  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2020-07-31
Completion
2021-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03514979 on ClinicalTrials.gov