An observational study of the reactogenicity and immunogenicity of 13-valent pneumococcal conjugate vaccine in women of
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Pneumonia
RESEARCH
Open Access
An observational study of the reactogenicity and immunogenicity of 13-valent pneumococcal conjugate vaccine in women of childbearing age in Papua New Guinea Sarah Javati1, Geraldine Masiria1, Arthur Elizah1, John-Paul Matlam1, Rebecca Ford1, Peter C. Richmond2,3, Deborah Lehmann3, William S. Pomat1,3 and Anita H. J. van den Biggelaar3*
Abstract Background: Maternal immunization with pneumococcal conjugate vaccine (PCV) may protect young infants in high-risk settings against the high risk of pneumococcal infections in early life. The aim of this study was to determine the safety and immunogenicity of 13-valent PCV (PCV13) in healthy women of childbearing age in PNG. Methods: As part of this observational study, 50 non-pregnant women of childbearing age (18-45 yrs. old) living in the highlands of PNG were vaccinated with a single dose of PCV13. Local and systemic reactogenicity were assessed 24–48 h after vaccination. Venous blood samples were collected before and 1 month after vaccination to measure PCV13 serotype-specific IgG antibody concentrations. Results: No severe adverse effects were reported during the 1-month follow-up period. IgG antibody concentrations significantly increased after vaccination for all PCV13 serotypes. One month after vaccination IgG antibody levels ≥2.5 μg/mL were reached in at least 75% of women for all PCV13 serotypes, except serotype 3, and ≥ 5 μg/mL in at least 75% of women for 7 serotypes (serotypes 6B, 9 V, 14, 18C, 19A, 19F and 23F). Conclusion: PCV13 is safe and immunogenic in women of childbearing age living in a high-risk setting in PNG. This supports the implementation of studies to investigate the safety and immunogenicity of maternal PCV vaccination in high-risk settings as a strategy to protect infants in these settings against the high risk of pneumococcal infections in early life. Trial registration: NCT04183322. Registered 3 December 2019 - Retrospectively registered Keywords: Pneumococcal, Vaccine, Pneumococcal conjugate vaccine, PCV, Adults, Non-pregnant, Childbearing age, WOCBA, Safety, Immunogenicity, Papua New Guinea
* Correspondence: [email protected] 3 Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute and Centre for Child Health Research, University of Western Australia, 15 Hospital Avenue, Nedlands, WA 6009, Australia Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's
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