Skip to main content
OpenTrials
Completed

NCT Number: NCT02463539

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pneumococcal Infection ANCA-associated Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Gram-Positive Bacterial Infections Immune System Diseases Infections Pneumococcal Infections Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Streptococcal Infections Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP ; Cochin Hospital

Paris, Île-de-France Region, 75014, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Residual anti-pneumococcal immunity after pneumococcal immunization.

    Time frame: visit V0 (day 0)

    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)

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

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

    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)

  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

    Time frame: visit V0 (day 0)

    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 )

  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.

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

    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.

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

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

    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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis. PneumoVas Pilot 1

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 4, 2015
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.