Safety and Immunogenicity of Pneumococcal Conjugate Vaccines in a High-risk Population: A Randomized Controlled Trial of 10-Valent and 13-Valent Pneumococcal Conjugate Vaccine in Papua New Guinean Infants

Clin Infect Dis. 2019 Apr 24;68(9):1472-1481. doi: 10.1093/cid/ciy743.

Abstract

Background: There are little data on the immunogenicity of PCV10 and PCV13 in the same high-risk population.

Methods: PCV10 and PCV13 were studied head-to-head in a randomized controlled trial in Papua New Guinea in which 262 infants received 3 doses of PCV10 or PCV13 at 1, 2, and 3 months of age. Serotype-specific immunoglobulin G (IgG) concentrations, and pneumococcal and nontypeable Haemophilus influenzae (NTHi) carriage were assessed prevaccination and at 4 and 9 months of age. Infants were followed up for safety until 9 months of age.

Results: One month after the third dose of PCV10 or PCV13, ˃80% of infants had IgG concentrations ≥0.35µg/mL for vaccine serotypes, and 6 months postvaccination IgG concentrations ≥0.35 µg/mL were maintained for 8/10 shared PCV serotypes in > 75% of children vaccinated with either PCV10 or PCV13. Children carried a total of 65 different pneumococcal serotypes (plus nonserotypeable). At 4 months of age, 92% (95% confidence interval [CI] 85-96) of children vaccinated with PCV10 and 81% (95% CI 72-88) vaccinated with PCV13 were pneumococcal carriers (P = .023), whereas no differences were seen at 9 months of age, or for NTHi carriage. Both vaccines were well tolerated and not associated with serious adverse events.

Conclusions: Infant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting; however, to significantly reduce pneumococcal disease in these settings, PCVs with broader serotype coverage and potency to reduce pneumococcal carriage are needed.

Clinical trials registration: NCT01619462.

Keywords: S. pneumonia; Papua New Guinea; antibodies; carriage; pneumococcal conjugate vaccine.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Bacterial / blood
  • Female
  • Haemophilus Infections / immunology
  • Haemophilus Infections / microbiology
  • Haemophilus Infections / prevention & control*
  • Haemophilus influenzae / drug effects
  • Haemophilus influenzae / growth & development
  • Haemophilus influenzae / immunology
  • Humans
  • Immunogenicity, Vaccine*
  • Immunoglobulin G / blood
  • Infant
  • Infant, Newborn
  • Male
  • Papua New Guinea
  • Patient Safety
  • Pneumococcal Vaccines / administration & dosage*
  • Pneumonia, Pneumococcal / immunology
  • Pneumonia, Pneumococcal / microbiology
  • Pneumonia, Pneumococcal / prevention & control*
  • Serogroup
  • Streptococcus pneumoniae / drug effects
  • Streptococcus pneumoniae / growth & development
  • Streptococcus pneumoniae / immunology
  • Vaccination / methods*

Substances

  • 10-valent pneumococcal conjugate vaccine
  • 13-valent pneumococcal vaccine
  • Antibodies, Bacterial
  • Immunoglobulin G
  • Pneumococcal Vaccines

Associated data

  • ClinicalTrials.gov/NCT01619462