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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
114
Pneumococcal vaccines
Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust
Cambridge, United Kingdom
Number of Rituximab Treated Patients Compared to Disease Controls Who Respond to the Pneumococcal Polysaccharide Conjugate Vaccine.
Response is defined as at least a twofold increase in immunoglobulins in at least 6/13 pneumococcal serotypes tested.
Time frame: Measured at 28 (+/- 7) days after administration of vaccine.
Number of Participants Who Have Responded by Individual Serotype in the Pneumococcal Vaccine
Immunoglobulin (IgG) titres for each individual serotype in the pneumococcal vaccine. Response is at least a two-fold increase in immunoglobulins from month 0.
Time frame: Measured at month 1 in all participants
Number of Participants Experiencing a Serious Adverse Event, or a Serious Adverse Event Specifically Related to the Vaccines Administered
Number of participants experiencing a serious adverse event, or a serious adverse events specifically related to the vaccines administered
Time frame: 7 months: end of trial
Number of Participants With Infections by Severity
Number of participants with infections by severity
Time frame: 7 months: end of trial
Changes in Immunoglobulin Levels
Changes in immunoglobulin levels at month 6 from month 0
Time frame: 6 months: end of trial
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