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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

2018; Oxford University Press; Volume: 68; Issue: 9 Linguagem: Inglês

10.1093/cid/ciy743

1537-6591

William Pomat, Anita H.J. van den Biggelaar, Sandra Wana, Jacinta P. Francis, Vela Solomon, Andrew R. Greenhill, Rebecca Ford, Tilda Orami, Megan Passey, Peter Jacoby, Lea‐Ann S. Kirkham, Deborah Lehmann, Peter Richmond, L Bele, Mary Dreyam, Arthur Elizah, Rebecca Ford, Jacinta P. Francis, A Gihigupa, Andrew R. Greenhill, Sarah Javati, John Kave, Wendy Kirarock, Mildred Lai, Brian K. Martin, Geraldine Masiria, A Michael, L Moliki, B Nagepu, M Nenikuro, Birunu Nivio, Christine Opa, Tilda Orami, William Pomat, G Saleu, Peter Siba, Vela Solomon, Sandra Wana, L Wawae, Mition Yoannes, Ilomo Hwaihwanje, T Korowi, Capt James J. Mond, P. K. Wari, Peter Jacoby, Deborah Lehmann, Anita H.J. van den Biggelaar, Karli J. Corscadden, Camilla de Gier, Lea‐Ann S. Kirkham, Tasmina Rahman, Peter Richmond, Ruth B. Thornton, Megan Passey,

Respiratory viral infections research

There are little data on the immunogenicity of PCV10 and PCV13 in the same high-risk population.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.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.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.NCT01619462.