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Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered in a prime-boost regimen among Chinese infants: a randomized, double blind phase III clinical trial
This study aimed to evaluate the immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine (PCV13). In total, 1200 infants were randomized into two groups with a 1:1 allocation and received a three-dose series of tested PCV13 or control PCV13 at ages 2, 4 and 6 months, respectively, an...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Taylor & Francis
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8942447/ https://www.ncbi.nlm.nih.gov/pubmed/35192784 http://dx.doi.org/10.1080/21645515.2021.2019498 |
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author | Wang, Wenjuan Liang, Qi Zhu, Jiahong Zhang, Junxia Chen, Junsheng Xie, Sulan Hu, Yuemei Li, Guifan |
author_facet | Wang, Wenjuan Liang, Qi Zhu, Jiahong Zhang, Junxia Chen, Junsheng Xie, Sulan Hu, Yuemei Li, Guifan |
author_sort | Wang, Wenjuan |
collection | PubMed |
description | This study aimed to evaluate the immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine (PCV13). In total, 1200 infants were randomized into two groups with a 1:1 allocation and received a three-dose series of tested PCV13 or control PCV13 at ages 2, 4 and 6 months, respectively, and a booster dose at 12–15 months. Blood samples were collected before and 30 days after primary and booster vaccination. Serotype-specific antibodies were measured using ELISA for immunoglobulin G (IgG) and OPA for functional antibodies. Safety data were collected for 30 days after each inoculation. Results showed that post primary vaccination seropositive rates of all 13 serotypes except type 3 were not significantly different between two groups. The seropositive rate for type 3 in Group T was significantly higher than Group C (P < .0001). For all 13 serotypes except type 7 F, the GMCs in Group T were significantly higher than Group C. The GMC for type 7 F in Group T (P < .0009) was significantly lower than Group C. The frequencies of overall adverse events (P = .0064) and solicited adverse reactions (P = .0019) in Group T were significantly lower than Group C. Post booster vaccination, seropositive rates for all serotypes in Group T were 100.00%. For all serotypes except type 23 F, IgG GMCs in Group T were significantly higher than Group C. Totally, 21 subjects reported SAEs and all but one were considered irrelevant or probably irrelevant to vaccination. In conclusion, the tested PCV13 showed non-inferior immunogenicity and had a good safety profile compared with control vaccine. |
format | Online Article Text |
id | pubmed-8942447 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Taylor & Francis |
record_format | MEDLINE/PubMed |
spelling | pubmed-89424472022-03-24 Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered in a prime-boost regimen among Chinese infants: a randomized, double blind phase III clinical trial Wang, Wenjuan Liang, Qi Zhu, Jiahong Zhang, Junxia Chen, Junsheng Xie, Sulan Hu, Yuemei Li, Guifan Hum Vaccin Immunother Pneumococcal – Research Paper This study aimed to evaluate the immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine (PCV13). In total, 1200 infants were randomized into two groups with a 1:1 allocation and received a three-dose series of tested PCV13 or control PCV13 at ages 2, 4 and 6 months, respectively, and a booster dose at 12–15 months. Blood samples were collected before and 30 days after primary and booster vaccination. Serotype-specific antibodies were measured using ELISA for immunoglobulin G (IgG) and OPA for functional antibodies. Safety data were collected for 30 days after each inoculation. Results showed that post primary vaccination seropositive rates of all 13 serotypes except type 3 were not significantly different between two groups. The seropositive rate for type 3 in Group T was significantly higher than Group C (P < .0001). For all 13 serotypes except type 7 F, the GMCs in Group T were significantly higher than Group C. The GMC for type 7 F in Group T (P < .0009) was significantly lower than Group C. The frequencies of overall adverse events (P = .0064) and solicited adverse reactions (P = .0019) in Group T were significantly lower than Group C. Post booster vaccination, seropositive rates for all serotypes in Group T were 100.00%. For all serotypes except type 23 F, IgG GMCs in Group T were significantly higher than Group C. Totally, 21 subjects reported SAEs and all but one were considered irrelevant or probably irrelevant to vaccination. In conclusion, the tested PCV13 showed non-inferior immunogenicity and had a good safety profile compared with control vaccine. Taylor & Francis 2022-02-22 /pmc/articles/PMC8942447/ /pubmed/35192784 http://dx.doi.org/10.1080/21645515.2021.2019498 Text en © 2022 The Author(s). Published with license by Taylor & Francis Group, LLC. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) ), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way. |
spellingShingle | Pneumococcal – Research Paper Wang, Wenjuan Liang, Qi Zhu, Jiahong Zhang, Junxia Chen, Junsheng Xie, Sulan Hu, Yuemei Li, Guifan Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered in a prime-boost regimen among Chinese infants: a randomized, double blind phase III clinical trial |
title | Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered in a prime-boost regimen among Chinese infants: a randomized, double blind phase III clinical trial |
title_full | Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered in a prime-boost regimen among Chinese infants: a randomized, double blind phase III clinical trial |
title_fullStr | Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered in a prime-boost regimen among Chinese infants: a randomized, double blind phase III clinical trial |
title_full_unstemmed | Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered in a prime-boost regimen among Chinese infants: a randomized, double blind phase III clinical trial |
title_short | Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered in a prime-boost regimen among Chinese infants: a randomized, double blind phase III clinical trial |
title_sort | immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered in a prime-boost regimen among chinese infants: a randomized, double blind phase iii clinical trial |
topic | Pneumococcal – Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8942447/ https://www.ncbi.nlm.nih.gov/pubmed/35192784 http://dx.doi.org/10.1080/21645515.2021.2019498 |
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