Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis

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

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-11-30

Brief Summary

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Exploratory study of anti-pneumococcal immune response in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) immunized according to new vaccine recommendations (i.e. with a combined vaccine schedule (13-valent conjugate pneumococcal vaccine -PCV13- followed by a 23-valent non-conjugate pneumococcal vaccine -PPV23- 8 weeks later).

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Detailed Description

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The purpose of this study is to determine whether this vaccination schedule induces sufficient protective immunity (serotype-specific enzyme linked immunosorbent assay (ELISA) and opsonophagocytosis (OPA) response rates) in AAV-patients receiving immunosuppressive therapy.

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
* ANCA-associated vasculitis: diagnosis of granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis according to American College of Rheumatology criteria
* Indication for pneumococcal vaccination according to French recommendations (statement of the Haut Conseil de Santé Publique regarding pneumococcal vaccination for adults and children older than 2 years old at risk for invasive pneumococcal disease, April 25Th 2013)

Exclusion Criteria

* History of pneumococcal immunization 36 months to 24hours before VO.
* Patients with known, or suspected pregnancy
* Patients planning to get pregnant in the year following inclusion
* Splenectomy
* Eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss) flare
* Infection during the week before inclusion
* Patient without social security coverage
* Individuals opposal

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No