MedTrace Logo

23-valent Polysaccharide Pneumococcal Vaccine in Juvenile Idiopathic Arthritis Patients Under Anti-TNF Therapy

NCT02196480 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2014-07-22

No results posted yet for this study

Summary

Objectives: To assess immunogenicity and safety of the 23-valent polysaccharide pneumococcal vaccine (PPV23) in JIA patients with and without anti-TNF therapy. The influences of demographic data, disease activity and treatment on immune response and the potential deleterious effect of vaccine on disease itself were also evaluated.

Methods: 17 JIA patients immediately pre-etanercept (Group 1) and 10 JIA patients on stable dose of methotrexate (Group 2) will receive one dose of PPV23. All patients will be evaluated pre-vaccination, 2 months and 12 months post-vaccination for seven pneumoccocal serotypes. Serology will be performed by enzyme immunoassay and the immunogenicity endpoints will include seroprotection (SP), seroconversion (SP) and geometric mean concentration of antibodies (GMC). Clinical and laboratorial parameters of JIA will be evaluated before and after vaccination.

Conditions

  • Juvenile Idiopathic Arthritis

Interventions

BIOLOGICAL

anti-TNF

Anti-tumor necrosis factor therapy

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Nadia E Aikawa, MD, PhD · University of Sao Paulo

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-06-30
Completion
2012-06-30

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02196480 on ClinicalTrials.gov