Abstract
Synflorix™ (10-valent pneumococcal conjugate vaccine; GlaxoSmithKline Biologicals, Belgium) has been investigated globally to evaluate immunogenicity, safety and reactogenicity with different vaccination schedules and routine co-administered vaccines.1 As expected, population variability in immune responses following priming was observed between continents.2,3 In European studies, Synflorix™ was proven to be immunogenic post-primary and post-booster vaccination in terms of
-amount of antibody (ELISA) for the 10 serotypes and protein D (carrier for 8/10 serotypes) and
-functional antibodies (opsonophagocytic activity; OPA) for the 10 serotypes.1 Furthermore, Synflorix™ induced similar immunological memory following the licensed 3+1 schedule or the investigational 2+1 schedule in Europe, with robust immune responses after a challenge dose 2 years post-booster.4
Although not indicated for non-vaccine-serotypes, in clinical trials, Synflorix™ has induced cross- reactive immune responses (ELISA and OPA) and immunological memory against serotypes 6A and 19A post-primary4 and post-booster vaccination.5 An 11-valent prototype vaccine included serotype 3; however, no efficacy or immune memory was observed6 and it was removed from the final formulation.1 Synflorix™ decreased nasopharyngeal carriage of vaccine-serotypes in the second year of life by 23-35%.7 Whilst a trend towards increased carriage of non-vaccine-serotypes was observed,7 a trend towards decreased 6A carriage was noted in line with the cross-reactive immune response induced by Synflorix™.8 These data give the first indications of biological activity and effectiveness of Synflorix™. The efficacy of pneumococcal vaccines needs careful monitoring and ongoing trials (COMPAS9 and FinIP10) will evaluate efficacy and effectiveness, respectively, of Synflorix™ against invasive pneumococcal disease, pneumonia, acute otitis media and carriage.
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Wysocki, J. 2 Synflorix™: What Have We Learned From Immunogenicity Studies?. Pediatr Res 68 (Suppl 1), 1–2 (2010). https://doi.org/10.1203/00006450-201011001-00002
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DOI: https://doi.org/10.1203/00006450-201011001-00002
