NCT02463578

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

February 25, 2016

Status Verified

December 1, 2015

Enrollment Period

2.9 years

First QC Date

May 12, 2015

Last Update Submit

February 24, 2016

Conditions

Pneumococcal InfectionANCA-associated Vasculitis

Keywords

Pneumococcal infectionInvasive pneumococcal disease (IPD)Pneumococcal vaccineVaccinologyImmunocompromisedAuto-immune diseasesSystemic vasculitisANCA-associated vasculitis

Outcome Measures

Primary Outcomes (1)

  • 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))

Secondary Outcomes (5)

  • To assess serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F and 23F-specific immune responses after vaccination

    visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).

  • To assess serotype coverage increase after PPV23 injection

    visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).

  • 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.

    visit V0 (Day 0), visit V1(12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).

  • Change Outcome Measures-To assess the sustainability and evolution over time of the vaccine-induced immune response (ELISA and OPA)

    visit V2 (48 to 56 weeks after V0).

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

    visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients followed for ANCA-associated Vasculitis

You may qualify if:

  • 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)

You may not qualify if:

  • History of pneumococcal immunization 36 months to 24hours before VO.
  • Patients with known, or suspected pregnancy
  • Splenectomy
  • Eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss) flare
  • Patient without social security coverage
  • Individuals opposal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP ; Cochin Hospital

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

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Pneumococcal InfectionsAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisSystemic Vasculitis

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsVasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Matthieu Groh, MD, MSc

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthieu Groh, MD, MSc

CONTACT

matthieu.groh@cch.aphp.fr

Anaïs Maugard

CONTACT

anais.maugard@aphp.fr

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

June 4, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2018

Study Completion

November 1, 2018

Last Updated

February 25, 2016

Record last verified: 2015-12

Locations

FR(1)