Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics

Phase 4

Completed

• Conditions: Asthma
• Interventions: Biological: prevenar; Biological: pneumovax

• Registration Number: NCT00836641
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

Asthma is a major health problem in preschool children. Infections by pneumococci a the most frequent cause of airway infections, which tend to cause worsening of asthma. Vaccination against pneumococci is recommended by scientific boards and the medical community, in order to reduce the burden of disease. Data on the immunogenicity and safety of pneumococcal immunization in preschool asthmatics are scarce.

Detailed Description

Respiratory infections are major triggers of exacerbations in preschool asthma. Many countries' guidelines recommend immunization against pneumococci for patients suffering from chronic airway disease. Also the interval between priming and booster is a matter of debate.

We immunize a large group of preschool asthmatics (2-5 years old) sequentially: one dose of seven-valent pneumococcal conjugate vaccine (PCV-7) followed by a single dose of 23-valent pneumococcal polysaccharide vaccine (PPV-23). We randomly assign half of the vaccinees to receive PPV-23 eight weeks after PCV-7 (group A), and the rest to a 10-month interval (group B). Pneumococcal antibody concentrations to serotype 4, 5, 6B, 7, 9V, 14, 18c, 19F, and 23F are determined initially, after two, and 12 months after PCV-7. Local and systemic reactions to each vaccine are recorded.

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2008-10
• Study Completion: 2008-12
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Results First Submitted: 2013-04-04
• Status Verified: 2013-07
• Results First Submitted QC: 2013-07-30
• Last Update Submitted: 2013-07-30
• Results First Posted: 2013-09-02
• Last Update Posted: 2013-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• asthma classified according to the Global Initiative on Asthma (GINA) °1-2

Exclusion Criteria

• antecedent pneumococcal immunization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pneumococcal immunization (2 mo)	prevenar	one dose of pneumococcal conjugate vaccine (prevenar) followed after 2 months by one dose of pneumococcal polysaccharide vaccine (pneumovax)
pneumococcal immunization (10 mo)	pneumovax	one dose of pneumococcal conjugate vaccine (prevenar) followed after 10 months by one dose of pneumococcal polysaccharide vaccine (pneumovax)
pneumococcal immunization (2 mo)	pneumovax	one dose of pneumococcal conjugate vaccine (prevenar) followed after 2 months by one dose of pneumococcal polysaccharide vaccine (pneumovax)
pneumococcal immunization (10 mo)	prevenar	one dose of pneumococcal conjugate vaccine (prevenar) followed after 10 months by one dose of pneumococcal polysaccharide vaccine (pneumovax)

Primary Outcome Measures

Name	Time	Method
Immunogenicity of Pneumococcal Vaccination	12 months	we performed pneumococcal serotype specific ELISA according to WHO's criteria for protective threshold values (\>0.35 µg/ml).

Secondary Outcome Measures

Name	Time	Method
Number of Vaccinees With Adverse Events	12 months	we evaluated the safety and tolerability of sequential pneumococcal immunization as to local and systemic adverse events.