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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis: a Pilot Study Following New Vaccine Recommendations. PneumoVas

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 Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Anti-pneumococcal immunity after combined anti-pneumococcal immunization [ Time Frame: visit V1 (12 to 16 weeks after V0 (Day 0)) ]

Proportion of responder patients at V1 (12-weeks after PCV13 injection) 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 PCV13 and PPV23. A serotype is considered positive if the ELISA immunoglobulins G (IgG) antibody titter shows a two-fold increase from baseline (V0) to V1 and is ≥ 1 μg/ml


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To assess serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F and 23F-specific immune responses after vaccination [ Time Frame: visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0). ]
    ELISA specific antibody titres to serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F and 23F.
  • To assess serotype coverage increase after PPV23 injection [ Time Frame: visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0). ]
    Serotype 10A and 12F (e.g. 2 PPV23-specific serotypes) ELISA antibody concentrations
  • 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. [ Time Frame: visit V0 (Day 0), visit V1(12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0). ]
    For each of the following serotypes (4, 6B, 9V, 14, 18C, 19F and 23F), OPA titers will be measured in ELISA-responding patients at V0, V1, V2. Opsonophagocytic antibody activity is considered positive if the antibody titer shows a four-fold increase from V0 and is above a serotype-specific predefined threshold.
  • Change Outcome Measures-To assess the sustainability and evolution over time of the vaccine-induced immune response (ELISA and OPA) [ Time Frame: visit V2 (48 to 56 weeks after V0). ]
    For ELISA-responding patients at V1, antibody ELISA concentrations and OPA titers will be measured 52 weeks after PCV13 injection (V2).
  • Composite Outcome Measures - To identify epidemiologic, clinic and biologic predictive factors that may influence vaccine-induced immune response. [ Time Frame: visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0). ]
    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


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: May 12, 2015
Date Started: June 2015
Date Completion: November 2018
Last Updated: February 24, 2016
Last Verified: December 2015