Neue Pneumokokken-Konjugat impfstoffe

Zusammenfassung

Neben dem seit vielen Jahren verfügbaren 7-valenten Pneumokokken-Impfstoff sind weitere konjugierte Impfstoffe zugelassen (10-valent = Synflorix^®, 13-valent = Prevenar 13^®). Da echte Wirksamkeitsstudien nicht durchgeführt werden konnten, erfolgt(e) die Zulassung der neuen Impfstoffe auf Basis von serologischen Parametern (Lizenzierungskriterien der WHO). Hierbei kommen ELISA und OPA zum Einsatz. Ergebnisse und Interpretation werden im vorliegenden Artikel besprochen.

Summary

Among the 7-valent pneumococcal conjugate vaccine which has worldwide been used for years, a 10 valent pneumococcal conjugate vaccine (Synflorix^®) as well as a 13 valent pneumococcal conjugate vaccine (Prevenar 13^®) has been approved by EMEA since 2009. Clinical efficacy trials were not possible therefore the approval was based on (resulted from) serological parameters according to WHO licensure approval criterias. The parameters used in the clinical trials were ELISA and OPA. Results and interpretation of these values are described in this article.

Schlüsselwörter

Konjugierte Pneumokokken-Impfstoffe - Lizensierungskriterien - 10-valent - 13-valent

Keywords

Conjugated pneumococcal vaccines - licensure criteria - 10-valent - 13-valent

• Literatur

• 1 O‘Brien KL, Wolfson LJ, Watt J. et al. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet 2009; 374: 893-902.
• 2 Von Kries R, Toschke M, Siedler A, Reinert R. Final Report: Populationbased Nationalwide Study on Invasive Pneumococcal Infections among Children in Germany (1997-2004). Aachen: Dezember; 2005
• 3 Jefferson T, Ferroni E, Curtale F. et al. Streptococcus pneumoniae in western Europe: serotype distribution and incidence in children less than 2 years old. Lancet Infect Dis 2006; 6: 405-410.
• 4 Hick L, Harrisson L, Flannery B. et al. Incidence of pneumococcal disease due to non-pneumococcal conjugate vaccine (PCV7) serotypes in the United States during the era of widespread PCV7 vaccination, 1998-2004. J Infect Dis 2007; 196 (09) 1346-1354.
• 5 van der Linden M, Imöhl M, von Kries R. et al. National immunization program for Prevenar (PCV7) results in reduction of incidence of IPD in german children. ; 27th Annual meeting of the European Society for Paediatric Infectious Diseases; 9.-13.06.09, Brüssel, Belgien
• 6 Prymula R, Peeters P, Chrobok V. et al. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet 2006; 367 9512 740-748.
• 7 Henckaerts I, Goldblatt D, Ashton L, Poolman J. Critical differences between pneumococcal polysaccharide enzyme-linked immunosorbent assays with and without 22F inhibition at low antibody concentrations in pediatric sera. Clin Vacc Immunol 2006; 13: 356-360.
• 8 Vesikari T, Wysocki J, Chevallier B. et al. Imunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine. Pediatr Infect Dis J 2009; 28 (04) S66-76.
• 9 Knuf M, Szenborn L, Moro M, Petit C. et al. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J 2009; 28 (04) S97-S108 ; Review.
• 10 Rückinger S, van der Linden M, Reinert RR. et al. Reduction in the incidence of invasive pneumococcal disease after general vaccination with 7-valent pneumococcal conjugate vaccine in Germany. Vaccine 2009; 27 (31) 4136-4141. Epub 2009 May 9.