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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.
SUBMITTER: Pomat WS
PROVIDER: S-EPMC6481999 | biostudies-literature | 2019 Apr
REPOSITORIES: biostudies-literature
Pomat William S WS van den Biggelaar Anita H J AHJ Wana Sandra S Francis Jacinta P JP Solomon Vela V Greenhill Andrew R AR Ford Rebecca R Orami Tilda T Passey Megan M Jacoby Peter P Kirkham Lea-Ann LA Lehmann Deborah D Richmond Peter C PC
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20190401 9
<h4>Background</h4>There are little data on the immunogenicity of PCV10 and PCV13 in the same high-risk population.<h4>Methods</h4>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. ...[more]