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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: ANCA-associated Vasculitis; Pneumococcal Infection

Study type: Observational

Funder types: Other

Identifiers

NCT02463578

NI15002

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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