An observational study of the reactogenicity and immunogenicity of 13-valent pneumococcal conjugate vaccine in women of childbearing age in Papua New Guinea.

Autor: Javati S; Papua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province, 441, Papua New Guinea., Masiria G; Papua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province, 441, Papua New Guinea., Elizah A; Papua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province, 441, Papua New Guinea., Matlam JP; Papua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province, 441, Papua New Guinea., Ford R; Papua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province, 441, Papua New Guinea., Richmond PC; Division of Pediatrics, School of Medicine, Perth Children's Hospital, University of Western Australia, 15 Hospital Avenue, Nedlands, WA, 6009, Australia.; 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., Lehmann D; 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., Pomat WS; Papua New Guinea Institute of Medical Research, Homate Street, Goroka, Eastern Highlands Province, 441, Papua New Guinea.; 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., van den Biggelaar AHJ; 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. Anita.vandenbiggelaar@telethonkids.org.au.
Jazyk: angličtina
Zdroj: Pneumonia (Nathan Qld.) [Pneumonia (Nathan)] 2020 Nov 25; Vol. 12 (1), pp. 13. Date of Electronic Publication: 2020 Nov 25.
DOI: 10.1186/s41479-020-00076-1
Abstrakt: 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.
Databáze: MEDLINE
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