Can a vaccine test expose hidden immune weakness?

NCT ID NCT03514979

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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