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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02463578
Other study ID # NI15002
Secondary ID
Status Recruiting
Phase N/A
First received May 12, 2015
Last updated February 24, 2016
Start date June 2015
Est. completion date November 2018

Study information

Verified date December 2015
Source Assistance Publique - Hôpitaux de Paris
Contact Matthieu Groh, MD, MSc
Email matthieu.groh@cch.aphp.fr
Is FDA regulated No
Health authority France: Ethics CommitteeFrance: Commission nationale de l'informatique et des libertésFrance: Ministry of Health
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date November 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France AP-HP ; Cochin Hospital Paris Ile de France

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anti-pneumococcal immunity after combined anti-pneumococcal immunization 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 visit V1 (12 to 16 weeks after V0 (Day 0)) No
Secondary To assess serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F and 23F-specific immune responses after vaccination ELISA specific antibody titres to serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F and 23F. visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0). No
Secondary To assess serotype coverage increase after PPV23 injection Serotype 10A and 12F (e.g. 2 PPV23-specific serotypes) ELISA antibody concentrations visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0). No
Secondary 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. 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. visit V0 (Day 0), visit V1(12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0). No
Secondary Change Outcome Measures-To assess the sustainability and evolution over time of the vaccine-induced immune response (ELISA and OPA) For ELISA-responding patients at V1, antibody ELISA concentrations and OPA titers will be measured 52 weeks after PCV13 injection (V2). visit V2 (48 to 56 weeks after V0). No
Secondary 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 visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0). No
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