Abstract

ABSTRACTTo investigate long-term antibody persistence following the administration of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV), we present results of 2 follow-up studies assessing antibody persistence following 2 3+1 schedules up to 4 (NCT00624819 – Study A) and 5 years (NCT00891176 – Study B) post-booster vaccination. In Study A, antibody persistence was measured one, 2 and 4 years post-booster in children previously primed and boosted with PHiD-CV, or primed with the 7-valent pneumococcal conjugate vaccine (7vCRM) and boosted with either PHiD-CV or 7vCRM. In Study B, PHiD-CV was co-administered with meningococcal vaccines, and pneumococcal antibody persistence was measured 2, 3 and 5 years post-booster. An age-matched control group, unvaccinated against Streptococcus pneumoniae, was enrolled in Study A, allowing assessment of immunologic memory by administration of one dose of PHiD-CV to both primed (4 years post-booster) and unprimed 6-year-old children. Four years post-booster (Study A), antibody concentrations and opsonophagocytic activity (OPA) titers remained higher compared to the pre-booster timepoint, with no major differences between the 3 primed groups. Antibody persistence was also observed in Study B, with minimal differences between groups. The additional PHiD-CV dose administered 4 years post-booster in Study A elicited more robust immune responses in primed children than in unprimed children. Long-term serotype-specific antibody persistence and robust immunologic memory responses observed in these 2 studies suggest induction of long-term protection against pneumococcal disease after PHiD-CV vaccination.

Highlights

  • Streptococcus pneumoniae is a leading cause of bacterial meningitis, sepsis, pneumonia and acute otitis media.[1]

  • At year 4, parents did not provide consent for participation in the immunologic memory assessment for 77 out of 426 children; only 349 primed children were included in the immunologic memory assessment

  • At year 4, 100 age-matched children who had not previously received any pneumococcal vaccine were enrolled, totaling to 449 children included in the total vaccinated cohort (TVC) for immunologic memory assessment

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Summary

Introduction

Streptococcus pneumoniae is a leading cause of bacterial meningitis, sepsis, pneumonia and acute otitis media.[1] The greatest disease burden is in children younger than 5 years.[2,3,4] Antibodies against capsular polysaccharides of various S. pneumoniae serotypes provide serotype-specific protection against pneumococcal infections through antibody-mediated opsonophagocytosis,[5,6,7,8] assessment of long term persistence of antibodies is important. Antibody persistence after infant vaccination with PHiD-CV beyond 2 years post-booster is unclear.[17,18]

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