Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomized Controlled Phase 4 Study on the Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics

Conditions
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Asthma

Intervention / Treatment
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* Biological: prevenar
* Biological: pneumovax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: asthma classified according to the Global Initiative on Asthma (GINA) °1-2 Exclusion Criteria: antecedent pneumococcal immunization

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pneumococcal immunization (2 mo)<br>one dose of pneumococcal conjugate vaccine (prevenar) followed after 2 months by one dose of pneumococcal polysaccharide vaccine (pneumovax) | Biological: prevenar<br>* 7-valent pneumococcal conjugate vaccine<br>* Other names: Prevnar, PCV-7;Biological: pneumovax<br>* 23 valent pneumococcal polysaccharide vaccine<br>* Other names: pneumopur, PPV-23;|
| Active Comparator: pneumococcal immunization (10 mo)<br>one dose of pneumococcal conjugate vaccine (prevenar) followed after 10 months by one dose of pneumococcal polysaccharide vaccine (pneumovax) | Biological: prevenar<br>* 7-valent pneumococcal conjugate vaccine<br>* Other names: Prevnar, PCV-7;Biological: pneumovax<br>* 23 valent pneumococcal polysaccharide vaccine<br>* Other names: pneumopur, PPV-23;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of Pneumococcal Vaccination | we performed pneumococcal serotype specific ELISA according to WHO's criteria for protective threshold values (>0.35 µg/ml). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Vaccinees With Adverse Events | we evaluated the safety and tolerability of sequential pneumococcal immunization as to local and systemic adverse events. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preschool asthma, sequential pneumococcal immunization, immunogenicity, safety