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

NCT02196480 | Completed Phase 4

• 1 other identifier: PPV23JIA-aTNF
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Seroprotection rate

  Sseroprotection rate (SP): percentage of subjects achieving antibodies titers ≥1.3 micrograms/mL

  2 months after vacccination

• Seroconversion rate

  Seroconversion rate (SC): percentage of subjects with a minimum of 2-fold rise in post-vaccination antibodies titers

  2 months after vaccination

• Number of participants with local and systemic adverse events

  Local reactions were considered to be related to the PPV23, while systemic adverse events were analyzed individually to determine their causality. Severe adverse events were defined as those requiring hospitalization or death.

  Until 12 months

Secondary Outcomes (4)

• Seroprotection rate

  12 months after vaccination

• Seroconversion rate

  12 months after vaccination

• Juvenile Arthritis Disease Activity Score with 27-joint reduced count (JADAS-27)

  2 months after vaccination

• Juvenile Arthritis Disease Activity Score with 27-joint reduced count (JADAS-27)

  12 months after vaccination

Study Arms (2)

Methotrexate

NO INTERVENTION

JIA patients on stable dose of methotrexate vaccinated with PPV23

anti-TNF

EXPERIMENTAL

JIA patients refractory to methotrexate immediately before the association of anti-TNF vaccinated with PPV23

Biological: anti-TNF

Interventions

anti-TNF BIOLOGICAL

Anti-tumor necrosis factor therapy

anti-TNF

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Juvenile idiopathic arthritis criteria (International League Against Rheumatism criteria)
• ≥ 5 and ≤ 18 years old

You may not qualify if:

• Previous vaccination against S. pneumoniae

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Centro de Dispensação de Medicamentos de Alto Custo (CEDMAC)

São Paulo, São Paulo, 01246-903, Brazil

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nadia E Aikawa, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 22, 2014
• Study Start: January 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2012
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

BR (1)