Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants

David Greenberg, Patricia A. Hoover, Timo Vesikari, Christopher Peltier, David C. Hurley, Richard D. McFetridge, Michael Dallas, Jonathan Hartzel, Rocio D. Marchese, Beth Ann G. Coller, Jon E. Stek, Chitrananda Abeygunawardana, Michael A. Winters, John E. MacNair, Narahari S. Pujar, Luwy Musey

Research output: Contribution to journalArticlepeer-review

55 Scopus citations

Abstract

Background: Pediatric use of pneumococcal conjugate vaccines (PCV) has been associated with significant decrease in disease burden. However, disease caused by non-vaccine serotypes has increased. Safety and immunogenicity of 15-valent PCV (PCV15) containing serotypes included in 13-valent PCV (PCV13) plus serotypes 22F and 33F were evaluated in infants (NCT01215188). Methods: Infants received adjuvanted PCV15, nonadjuvanted PCV15, or PCV13 at 2, 4, 6, and 12–15 months of age. Safety was monitored for 14 days after each dose. Serotype-specific IgG geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured at postdose-3, predose-4, and postdose-4. Results: Safety profiles were comparable across vaccination groups. At postdose-3, both PCV15 formulations were non-inferior to PCV13 for 10 of 13 shared serotypes but failed non-inferiority for 3 serotypes (6A, 6B, and 19A) based on proportion of subjects achieving IgG GMC ≥0.35 µg/mL. Adjuvanted PCV15 and nonadjuvanted PCV15 were non-inferior to PCV13 for 11 and 8 shared serotypes, respectively, based on postdose 3 comparisons of GMC ratios. PCV15 induced higher antibodies to serotypes 3, 22F, and 33F than PCV13. Conclusions: PCV15 displayed acceptable safety profile and induced IgG and OPA to all 15 vaccine serotypes at levels comparable to PCV13 for 10 of 13 shared serotypes. Study identification: V114-003. CLINICALTRIALS.GOV identifier: NCT01215188.

Original languageEnglish
Pages (from-to)6883-6891
Number of pages9
JournalVaccine
Volume36
Issue number45
DOIs
StatePublished - 29 Oct 2018
Externally publishedYes

Keywords

  • Immunogenicity
  • Pneumococcal conjugate vaccine
  • Safety

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology (all)
  • Veterinary (all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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