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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02196480
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Nádia Emi Aikawa, University of Sao Paulo

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.


Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Biological: anti-TNF Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Short and Long-term Immunogenicity and Safety Following the 23-valent Polysaccharide Pneumococcal Vaccine in Juvenile Idiopathic Arthritis Patients Under Anti-TNF Therapy
Study Start Date : January 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2012


Arm Intervention/treatment
No Intervention: Methotrexate
JIA patients on stable dose of methotrexate vaccinated with PPV23
Experimental: anti-TNF
JIA patients refractory to methotrexate immediately before the association of anti-TNF vaccinated with PPV23
Biological: anti-TNF
Anti-tumor necrosis factor therapy




Primary Outcome Measures :
  1. Seroprotection rate [ Time Frame: 2 months after vacccination ]
    Sseroprotection rate (SP): percentage of subjects achieving antibodies titers ≥1.3 micrograms/mL

  2. Seroconversion rate [ Time Frame: 2 months after vaccination ]
    Seroconversion rate (SC): percentage of subjects with a minimum of 2-fold rise in post-vaccination antibodies titers

  3. Number of participants with local and systemic adverse events [ Time Frame: Until 12 months ]
    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.


Secondary Outcome Measures :
  1. Seroprotection rate [ Time Frame: 12 months after vaccination ]
    Seroprotection rate (SP): percentage of subjects achieving antibodies titers ≥1.3 micrograms/mL

  2. Seroconversion rate [ Time Frame: 12 months after vaccination ]
    Seroconversion rate (SC): percentage of subjects with a minimum of 2-fold rise in post-vaccination antibodies titers

  3. Juvenile Arthritis Disease Activity Score with 27-joint reduced count (JADAS-27) [ Time Frame: 2 months after vaccination ]
    The Juvenile Arthritis Disease Activity Score with 27-joint reduced count (JADAS-27) is defined as the linear sum of the scores of 4 components [physician global assessment of disease activity (measured on a 10-cm VAS), parent/patient global assessment of well-being (measured on a 10-cm VAS); number of active joints (0-27 joints); and ESR] (range: 0 - 57 points)

  4. Juvenile Arthritis Disease Activity Score with 27-joint reduced count (JADAS-27) [ Time Frame: 12 months after vaccination ]
    The Juvenile Arthritis Disease Activity Score with 27-joint reduced count (JADAS-27) is defined as the linear sum of the scores of 4 components [physician global assessment of disease activity (measured on a 10-cm VAS), parent/patient global assessment of well-being (measured on a 10-cm VAS); number of active joints (0-27 joints); and ESR] (range: 0 - 57 points)



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous vaccination against S. pneumoniae

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196480


Locations
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Brazil
Centro de Dispensação de Medicamentos de Alto Custo (CEDMAC)
Sao Paulo, Brazil, 01246-903
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Nadia E Aikawa, MD, PhD University of Sao Paulo

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Responsible Party: Nádia Emi Aikawa, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02196480    
Other Study ID Numbers: PPV23JIA-aTNF
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors