Systemic VasculitisPhase 2ACQUIVASNCT03514979

Acquired Immunodeficiency in ANCA Associated Vasculitis

A Phase 2 study testing Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide Vaccination in people with Systemic Vasculitis, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for: Systemic Vasculitis
What is being tested?: Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide Vaccination
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 1 siteUnited Kingdom
Study dates: 15 Oct 2018to 14 Dec 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust
Cambridge, CB20QQ

Other trials in United Kingdom

About this study

Official title: Acquired Immunodeficiency in ANCA (Antineutrophil Cytoplasmic Antibody) Associated Vasculitis

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:

To investigate whether rituximab leads to immune deficiency in patients with AAV when compared to both disease and healthy controls.
To investigate whether the degree of immune deficiency is associated with the degree of B cell depletion.
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
Being tested: Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide Vaccination
Medical subject headings: Systemic Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide VaccinationBiological
Also called Prevnar 13 and Pneumovax
Pneumococcal vaccines

Study groups in NCT03514979
Study group	Role	What they receive
AAV patients treated with rituximab	Experimental	Pneumococcal Polysaccharide Conjugate vaccination at Month 0 and then Pneumococcal Polysaccharide Vaccination at Month 6. Receives: Biological: Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide Vaccination
AAV patients - never received rituximab	Experimental	Pneumococcal Polysaccharide Conjugate vaccination at Month 0 and then Pneumococcal Polysaccharide Vaccination at Month 6. Receives: Biological: Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide Vaccination
Healthy controls	Experimental	Pneumococcal Polysaccharide Conjugate vaccination at Month 0 and then Pneumococcal Polysaccharide Vaccination at Month 6. Receives: Biological: Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide Vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Measured at 28 (+/- 7) days after administration of vaccine.

Secondary outcomes (4)

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.
Measured: 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
Measured: 7 months: end of trial
Number of Participants With Infections by Severity
Number of participants with infections by severity
Measured: 7 months: end of trial
Changes in Immunoglobulin Levels
Changes in immunoglobulin levels at month 6 from month 0
Measured: 6 months: end of trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201814 Dec 2022

First posted3 May 2018
Study start15 Oct 2018
Primary completion14 Dec 2022
Study completion14 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Systemic VasculitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: This is a phase IIb, open label study to evaluate the responses of patients with ANCA associated vasculitis (AAV) to pneumococcal vaccination. It has been designed primarily to assess the immunogenicity of pneumococcal vaccines in patients with AAV treated with rituximab compared to disease controls, but also to provide mechanistic information on vaccine response by comparing AAV patients and healthy controls.
Masking: None (open label)
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03514979
Sponsor's protocol ID: CCTU0155
Acronym: ACQUIVAS
Status last verified: Jun 2026
First submitted: 13 Apr 2018
Last updated: 8 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Systemic Vasculitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acquired Immunodeficiency in ANCA (Antineutrophil Cytoplasmic Antibody) Associated Vasculitis
ClinicalTrials.gov ID: NCT03514979
Acronym / sponsor ID: ACQUIVAS / CCTU0155
Conditions: Systemic Vasculitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
Collaborators: Arthritis Research UK
Study start: 15 Oct 2018 (actual)
Primary completion: 14 Dec 2022 (actual)
Study completion: 14 Dec 2022 (actual)
First posted: 3 May 2018 (actual)
Results: Posted 8 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

To investigate whether rituximab leads to immune deficiency in patients with AAV when compared to both disease and healthy controls.
To investigate whether the degree of immune deficiency is associated with the degree of B cell depletion.
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 design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This is a phase IIb, open label study to evaluate the responses of patients with ANCA associated vasculitis (AAV) to pneumococcal vaccination. It has been designed primarily to assess the immunogenicity of pneumococcal vaccines in patients with AAV treated with rituximab compared to disease controls, but also to provide mechanistic information on vaccine response by comparing AAV patients and healthy controls.

Arm	Type	Receives
AAV patients treated with rituximab	Experimental	Biological: Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide VaccinationPneumococcal Polysaccharide Conjugate vaccination at Month 0 and then Pneumococcal Polysaccharide Vaccination at Month 6.
AAV patients - never received rituximab	Experimental	Biological: Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide VaccinationPneumococcal Polysaccharide Conjugate vaccination at Month 0 and then Pneumococcal Polysaccharide Vaccination at Month 6.
Healthy controls	Experimental	Biological: Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide VaccinationPneumococcal Polysaccharide Conjugate vaccination at Month 0 and then Pneumococcal Polysaccharide Vaccination at Month 6.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Have given written informed consent to participate
Be aged 40 years and over
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

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide VaccinationAlso: Prevnar 13 and PneumovaxPneumococcal vaccines	Biological	AAV patients - never received rituximab, AAV patients treated with rituximab, Healthy controls

Primary outcome

Number of Rituximab Treated Patients Compared to Disease Controls Who Respond to the Pneumococcal Polysaccharide Conjugate Vaccine.
Time frame: Measured at 28 (+/- 7) days after administration of vaccine.
Response is defined as at least a twofold increase in immunoglobulins in at least 6/13 pneumococcal serotypes tested.

4 secondary outcomes

Number of Participants Who Have Responded by Individual Serotype in the Pneumococcal Vaccine
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
Time frame: 7 months: end of trial
Number of Participants With Infections by Severity
Time frame: 7 months: end of trial
Changes in Immunoglobulin Levels
Time frame: 6 months: end of trial

Results and safety

Results posted to the registry on 8 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AAV Patients Treated With Rituximab	54	54
AAV Patients - Never Received Rituximab	53	53
Healthy Controls	7	7

Primary outcome: Number of Rituximab Treated Patients Compared to Disease Controls Who Respond to the Pneumococcal Polysaccharide Conjugate Vaccine.

Time frame: Measured at 28 (+/- 7) days after administration of vaccine.. Count of participants. Unit: Participants

Measure	AAV Patients Treated With Rituximab n = 52	AAV Patients - Never Received Rituximab n = 47	Healthy Controls n = 6
Value	4	21	2

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are collected until the end of trial at Month 7 or until time of withdrawal.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AAV Patients Treated With Rituximab	2 of 54 (3.7%)	10 of 54 (18.5%)	13 of 54
AAV Patients - Never Received Rituximab	3 of 53 (5.7%)	11 of 53 (20.8%)	11 of 53
Healthy Controls	1 of 7 (14.3%)	1 of 7 (14.3%)	2 of 7

Limitations and caveats (from the sponsor): The trial was conducted during the COVID-19 pandemic which led to withdrawals.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rona Smith, MD MRCP principal investigator

University of Cambridge

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Rituximab Treated Patients Compared to Disease Controls Who Respond to the Pneumococcal Polysaccharide Conjugate Vaccine. (time frame: Measured at 28 (+/- 7) days after administration of vaccine.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03514979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.