13-valent pneumococcal conjugate vaccine (PCV13) is immunogenic and safe in children 6-17 years of age with sickle cell disease previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23): Results of a phase 3 study

Pediatr Blood Cancer. 2015 Aug;62(8):1427-36. doi: 10.1002/pbc.25502. Epub 2015 Mar 23.


Background: A large population of older children with sickle cell disease (SCD) is currently vaccinated with only 23-valent pneumococcal polysaccharide vaccine (PPSV23). In immunocompetent adults, PPSV23 vaccination reduces immune responses to subsequent vaccination with a pneumococcal vaccine. The 13-valent pneumococcal conjugate vaccine (PCV13), which addresses this limitation, may offer an advantage to this population at high risk of pneumococcal disease.

Procedure: Children with SCD 6-17 years of age previously vaccinated with PPSV23 at least 6 months before study enrollment received two doses of PCV13 6 months apart. Anti-pneumococcal polysaccharide immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured before, 1 month after each administration, and 1 year after the second administration.

Results: Following each PCV13 administration, IgG GMCs and OPA GMTs significantly increased, and antibody levels after doses 1 and 2 were generally comparable. Antibody levels declined over the year following dose 2. At 1 year after the second administration, OPA GMTs for all and IgG GMCs for most serotypes remained above pre-vaccination levels. Most adverse events were due to vaso-occlusive crises, a characteristic of the underlying condition of SCD.

Conclusions: Children with SCD who were previously vaccinated with PPSV23 responded well to 1 PCV13 dose, and a second dose did not increase antibody response. PCV13 antibodies persisted above pre-vaccination levels for all serotypes 1 year after dose 2. Children with SCD may benefit from at least one dose of PCV13.

Keywords: 13-valent pneumococcal conjugate vaccine; 23-valent pneumococcal polysaccharide vaccine; hydroxycarbamide; immunogenicity; safety; sickle cell disease.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Adolescent
  • Anemia, Sickle Cell / immunology*
  • Antibodies, Bacterial / blood*
  • Antibodies, Bacterial / immunology
  • Child
  • Female
  • Humans
  • Immunization, Secondary
  • Immunoglobulin G / blood
  • Immunoglobulin G / immunology
  • Male
  • Phagocytosis / immunology
  • Pneumococcal Infections / immunology
  • Pneumococcal Infections / prevention & control
  • Pneumococcal Vaccines / immunology*
  • Streptococcus pneumoniae / immunology
  • Vaccines, Conjugate / immunology*


  • 13-valent pneumococcal vaccine
  • 23-valent pneumococcal capsular polysaccharide vaccine
  • Antibodies, Bacterial
  • Immunoglobulin G
  • Pneumococcal Vaccines
  • Vaccines, Conjugate