- Title
- 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
- Creator
- Pomat, William; Van Den Biggelaar, Anita; Wana, Sandra; Francis, Jacinta; Solomon, Vela; Greenhill, Andrew; Ford, Rebecca; Orami, Tilda; Passey, Megan; Jacoby, Peter; Kirkham, Lea-Ann; Lehmann, Deborah; Richmond, Peter
- Date
- 2019
- Type
- Text; Journal article
- Identifier
- http://researchonline.federation.edu.au/vital/access/HandleResolver/1959.17/169859
- Identifier
- vital:14097
- Identifier
-
https://doi.org/10.1093/cid/ciy743
- Identifier
- ISBN:1058-4838
- 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.
- Publisher
- Oxford University Press
- Relation
- Clinical Infectious Diseases Vol. 68, no. 9 (2019), p. 1472-1481
- Rights
- http://creativecommons.org/licenses/by-nc-nd/4.0/
- Rights
- Copyright © The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/ by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com DOI: 10.1093/cid/ciy743.
- Rights
- Open Access
- Rights
- This metadata is freely available under a CCO license
- Subject
- 06 Biological Sciences; 11 Medical and Health Sciences; Antibodies; Carriage; Papua New Guinea; Pneumococcal conjugate vaccine; S. pneumonia
- Full Text
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