NCT03514979

Acquired Immunodeficiency in ANCA Associated Vasculitis

Acquired Immunodeficiency in ANCA (Antineutrophil Cytoplasmic Antibody) Associated Vasculitis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide Vaccination	Pneumococcal vaccines

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-07-01
• Completion: 2021-01-01
• First posted: 2018-05-03
• Last updated: 2018-05-03