Can a vaccine test expose hidden immune weakness?
NCT ID NCT03514979
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This trial tests whether rituximab, a drug used for ANCA-associated vasculitis, leaves patients with a weakened immune system. Researchers give pneumococcal vaccines to patients treated with rituximab, patients with the disease but not on rituximab, and healthy volunteers. They compare how well each group's immune system responds to the vaccine. The goal is to see if rituximab impairs vaccine responses and whether a conjugated vaccine can overcome that deficit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pneumococcal vaccines (Prevnar 13 and Pneumovax)
- What this could lead to
- If it works, this could reveal whether rituximab weakens the immune system's ability to respond to vaccines, guiding better infection prevention for vasculitis patients.
- What could go wrong
- This is a small, early-stage study focused on immune markers, not clinical outcomes. Results may not predict real-world infection risk, and vaccine responses can vary widely among individuals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
114 people
The number who actually took part.
- Started
-
Oct 2018
- Finished
-
Dec 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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) For healthy controls: • Healthy individuals aged 40 years and over 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 * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for ANCA associated vasculitis are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust
Cambridge, CB20QQ, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a blood pressure pill shield blood vessels from heart attacks?
- A blood clue to a rare vessel disease?
- Immune clues in the blood may foretell heart trouble
- Can a new drug tame vasculitis with fewer side effects?
- Engineered immune cells take aim at autoimmune kidney diseases
- Could a diabetes drug shield kidneys from autoimmune attack?