Clinical trial NCT02463578: Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis
Official title: Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis: a Pilot Study Following New Vaccine Recommendations. PneumoVas Pilot 2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumococcal Infection
ANCA-associated Vasculitis
Keywords: Pneumococcal infection
Invasive pneumococcal disease (IPD)
Pneumococcal vaccine
Vaccinology
Immunocompromised
Auto-immune diseases
Systemic vasculitis
ANCA-associated vasculitis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed for ANCA-associated Vasculitis

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Anti-pneumococcal immunity after combined anti-pneumococcal immunization
timeFrame: visit V1 (12 to 16 weeks after V0 (Day 0))
Secondary outcomes:
measure: To assess serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F and 23F-specific immune responses after vaccination
timeFrame: visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).
measure: To assess serotype coverage increase after PPV23 injection
timeFrame: visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).
measure: For the following serotypes (4, 6B, 9V, 14, 18C, 19F and 23F), to assess the proportion of ELISA-responding patients who also show in vitro opsonophagocytic antibody activity.
timeFrame: visit V0 (Day 0), visit V1(12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).
measure: Change Outcome Measures-To assess the sustainability and evolution over time of the vaccine-induced immune response (ELISA and OPA)
timeFrame: visit V2 (48 to 56 weeks after V0).
measure: Composite Outcome Measures - To identify epidemiologic, clinic and biologic predictive factors that may influence vaccine-induced immune response.
timeFrame: visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP ; Cochin Hospital
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Matthieu Groh, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: