Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis

NCT ID: NCT02463539

Last Updated: 2016-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-08-31

Brief Summary

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Descriptive study of the residual anti-pneumococcal immunity in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) who have previously gone through pneumococcal immunization.

Detailed Description

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The purpose of this study is to determine, through serotype-specific enzyme linked immunosorbent assay (ELISA) and opsonophagocytosis (OPA) titres whether AAV patients who have gone through pneumococcal vaccination are protected against invasive pneumococcal diseases (IPD).

Conditions

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Pneumococcal Infection ANCA-associated Vasculitis

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis: diagnosis for granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis according to American College of Rheumatology criteria
* Anti-pneumococcal immunization in the past 36 months
* History of anti-pneumococcal vaccination according to French recommendations (simple vaccine schedule with PPV23 or combine vaccine schedule with PCV13 followed by PPV23 8 weeks later)

Exclusion Criteria

* Known or suspected pregnancy
* Splenectomy
* Patient without social security coverage
* Patient opposal
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthieu Groh, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

AP-HP- Cochin hospital

Locations

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AP-HP ; Cochin Hospital

Paris, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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NI 15001

Identifier Type: -

Identifier Source: org_study_id

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