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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pneumococcal immunization (2 mo) | Active Comparator | one dose of pneumococcal conjugate vaccine (prevenar) followed after 2 months by one dose of pneumococcal polysaccharide vaccine (pneumovax) |
|
| pneumococcal immunization (10 mo) | Active Comparator | one dose of pneumococcal conjugate vaccine (prevenar) followed after 10 months by one dose of pneumococcal polysaccharide vaccine (pneumovax) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prevenar | Biological | 7-valent pneumococcal conjugate vaccine |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Zielen, M.D. | Goethe University Childrens Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17073839 | Background | Rose MA, Schubert R, Kujumdshiev S, Kitz R, Zielen S. Immunoglobulins and immunogenicity of pneumococcal vaccination in preschool asthma. Int J Clin Pract. 2006 Nov;60(11):1425-31. doi: 10.1111/j.1742-1241.2006.01093.x. |
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11/2005-09/07: 70 outpatients (2-5-yo)with >3 asthma episodes during 12 months. Exclusion: pneumococcal immunization,severe/unstable asthma, systemic steroids, preterm birth (<37 weeks of gestation), low birthweight (<2500 g), major congenital abnormalities, and known intolerance towards ingredients of the pneumococcal vaccines.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Sequential Pneumococcal Immunzation (2 mo) | one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine |
| FG001 | Group B: Sequential Pneumococcal Immunization (10 mo) | one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A Pneumococcal Immunization (2 mo) | one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine |
| BG001 | Group B Pneumococcal Immunization (10 mo) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Immunogenicity of Pneumococcal Vaccination | we performed pneumococcal serotype specific ELISA according to WHO's criteria for protective threshold values (>0.35 µg/ml). | we performed a power calculation in advance. To demonstrate a difference wit p<0.05, we would require 30 subjects per arm each. Thus and to allow potential drop-outs, we included 35 subjects per arm. | Posted | Geometric Mean | 95% Confidence Interval | [µg/ml] | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Study Population | the whole study population was observed for adverse events. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Markus Rose | Goethe University Childrens Hospital | 0049-696301 | 5754 | Markus.Rose@kgu.de |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| pneumovax | Biological | 23 valent pneumococcal polysaccharide vaccine |
|
|
one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
|
|
| Secondary | Number of Vaccinees With Adverse Events | we evaluated the safety and tolerability of sequential pneumococcal immunization as to local and systemic adverse events. | Posted | Number | participants | 12 months |
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| 0 |
| 0 |
| 0 |
| 0 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D045424 |
| Complex Mixtures |
| D017778 | Vaccines, Combined |