NCT02463539

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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
23 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

May 12, 2015

Last Update Submit

August 18, 2016

Conditions

Pneumococcal InfectionANCA-associated Vasculitis

Keywords

Pneumococcal infectionInvasive pneumococcal disease (IPD)Pneumococcal vaccineSystemic vasculitisANCA-associated vasculitisVaccinologyImmunocompromisedAuto-immune disease

Outcome Measures

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)

    visit V0 (day 0)

Secondary Outcomes (4)

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

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

  • 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

    visit V0 (day 0)

  • 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.

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

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

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

Eligibility Criteria

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

Patients followed for Anti-neutrophil cytoplasmic antibody (ANCA)-associated Vasculitis

You may qualify if:

  • 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)

You may not qualify if:

  • Known or suspected pregnancy
  • Splenectomy
  • Patient without social security coverage
  • Patient opposal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP ; Cochin Hospital

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

Location

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

    AP-HP- Cochin hospital

    PRINCIPAL INVESTIGATOR

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

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

August 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

FR(1)