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

Browse trials for

• Pneumococcal Infections 281
• Vasculitis 230
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis 139

Keywords

• Pneumococcal infection
• Invasive pneumococcal disease (IPD)
• Pneumococcal vaccine
• Systemic vasculitis
• ANCA-associated vasculitis
• Vaccinology
• Immunocompromised
• Auto-immune disease

Pneumococcal Infections

281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.

This study's enrollment of 19 is below the median of 735 across 48 observational studies indexed under Pneumococcal Infections.

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Study population

Primary outcomes

1. Residual anti-pneumococcal immunity after pneumococcal immunization.

   Proportion of patients at baseline (V0) with ≥1 µg/mL ELISA immunoglobulins G (IgG) antibody titers to at least 6 of the 10 shared serotypes (i.e. 3, 4, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) included both in the 13-valent conjugate pneumococcal vaccine (PCV13) and in the 23-valent non-conjugate pneumococcal vaccine (PPV23)

   Time frame: visit V0 (day 0)

Secondary outcomes

1. To assess serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F, 23F, 10A and 12F-specific residual immunity after vaccination

   ELISA specific antibody titres to serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F, 23F (included both in PCV13 and PPV23), 10A and 12F (specific to PPV23)

   Time frame: visit V0 (day 0), visit V-1 (pre immunization)

2. 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

   Descriptive analysis: a/ For each of the following serotypes (3, 4, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), opsonophagocytosis (OPA) titers will be measured in ELISA-protected patients at V0. Opsonophagocytic antibody activity is considered positive if the antibody titer is above a serotype-specific predefined threshold. B/ The proportion of overall OPA-protected patients (meaning ≥ 50% of OPA positive serotypes )

   Time frame: visit V0 (day 0)

3. 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.

   For patients already included in the PHENOVASC study (V-1) ≤6 months before receiving pneumococcal immunization, anti-pneumococcal immunity will be assessed for serotype 3 , 4 , 6B, 7F, 9V, 14 , 18C, 19A , 19F , 23F, 10A and 12F (with ELISA only for the two latter). For each serotype: In ELISA, we will describe the proportion of responding patients (i.e. with a two-fold increase from V-1 to VO and a ≥1 μg/ml titre at V0. In VO ELISA-responding patients, OPA titers will be measured. An opsonophagocytic antibody activity is considered positive if the antibody titer shows a four-fold increase from V-1 to V0 and is above a serotype-specific predefined threshold.

   Time frame: visit V-1 (pre immunization) ; visit V0 (day 0)

4. Composite Outcome Measures - To identify epidemiologic, clinic and biologic predictive factors that may influence vaccine-induced immune response.

   Analysis of epidemiological, clinical and biological data collected during follow-up: age, sex, history of immunosuppressive therapy, time since previous PPV23 injection, number of previous PPV23 immunizations, AAV activity and severity according to Birmingham Vasculitis Activity Score and Vasculitis Damage Index, results of biological analyses

   Time frame: visit V-1 (pre immunization) ; visit V0 (day 0)