Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics (PAPSI)

Johann Wolfgang Goethe University Hospital

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Biological: pneumovax; Biological: prevenar

Study type: Interventional

Funder types: Other

Identifiers

NCT00836641

PAPSI.FFM.3217

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• antecedent pneumococcal immunization

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

pneumococcal immunization (2 mo)

Active Comparator group

Description:

one dose of pneumococcal conjugate vaccine (prevenar) followed after 2 months by one dose of pneumococcal polysaccharide vaccine (pneumovax)

Treatment:

Biological: prevenar

Biological: pneumovax

pneumococcal immunization (10 mo)

Active Comparator group

Description:

one dose of pneumococcal conjugate vaccine (prevenar) followed after 10 months by one dose of pneumococcal polysaccharide vaccine (pneumovax)

Treatment:

Biological: prevenar

Biological: pneumovax