Clinical trial NCT02463539: Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis
Official title: Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis. PneumoVas Pilot 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Infection
ANCA-associated Vasculitis
Keywords: Pneumococcal infection
Invasive pneumococcal disease (IPD)
Pneumococcal vaccine
Systemic vasculitis
ANCA-associated vasculitis
Vaccinology
Immunocompromised
Auto-immune disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 19
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 Anti-neutrophil cytoplasmic antibody (ANCA)-associated Vasculitis

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Residual anti-pneumococcal immunity after pneumococcal immunization.
timeFrame: visit V0 (day 0)
Secondary outcomes:
measure: To assess serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F, 23F, 10A and 12F-specific residual immunity after vaccination
timeFrame: visit V0 (day 0), visit V-1 (pre immunization)
measure: For each of the following serotypes (3, 4, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), to assess among ELISA-protected patients (i.e. with a ≥1 µg/mL ELISA IgG antibody titer) the proportion who also show in vitro opsonophagocytic antibody activity
timeFrame: visit V0 (day 0)
measure: For patients for whom pre-vaccinal serum is available (via the PHENOVASC bank), to assess the impact of immunization on serotype-specific ELISA antibody titer and OPA activity.
timeFrame: visit V-1 (pre immunization) ; visit V0 (day 0)
measure: Composite Outcome Measures - To identify epidemiologic, clinic and biologic predictive factors that may influence vaccine-induced immune response.
timeFrame: visit V-1 (pre immunization) ; visit V0 (day 0)
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP ; Cochin Hospital
state: Ile de France
Study officials:
affiliation: AP-HP- Cochin hospital
name: Matthieu Groh, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: