Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics

Asthma Clinical Trial

— PAPSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836641
• Other study ID #: PAPSI.FFM.3217
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2009
• Last updated: July 30, 2013
• Start date: October 2006
• Est. completion date: December 2008

Study information

• Verified date: July 2013
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• antecedent pneumococcal immunization

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• prevenar
7-valent pneumococcal conjugate vaccine
• pneumovax
23 valent pneumococcal polysaccharide vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes