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Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women

A new HPV-16/18 bivalent vaccine expressed by the Escherichia coli has been proven to be efficacious in adult women. A randomized, immunogenicity noninferiority study of this candidate vaccine was conducted in December 2015 in China. Girls aged 9–14 years were randomized to receive 2 doses at months...

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Autores principales: Hu, Yue-Mei, Guo, Meng, Li, Chang-Gui, Chu, Kai, He, Wen-Gang, Zhang, Jing, Gu, Jian-Xiang, Li, Juan, Zhao, Hui, Wu, Xiang-Hong, Lin, BiZhen, Lin, Zhi-Jie, Yao, Xing-Mei, Li, Ya-Fei, Wei, FeiXue, Huang, Yue, Su, Ying-Ying, Zhu, Feng-Cai, Huang, Shou-Jie, Pan, Hui-Rong, Wu, Ting, Zhang, Jun, Xia, Ning-Shao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Science China Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7223315/
https://www.ncbi.nlm.nih.gov/pubmed/31231780
http://dx.doi.org/10.1007/s11427-019-9547-7
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author Hu, Yue-Mei
Guo, Meng
Li, Chang-Gui
Chu, Kai
He, Wen-Gang
Zhang, Jing
Gu, Jian-Xiang
Li, Juan
Zhao, Hui
Wu, Xiang-Hong
Lin, BiZhen
Lin, Zhi-Jie
Yao, Xing-Mei
Li, Ya-Fei
Wei, FeiXue
Huang, Yue
Su, Ying-Ying
Zhu, Feng-Cai
Huang, Shou-Jie
Pan, Hui-Rong
Wu, Ting
Zhang, Jun
Xia, Ning-Shao
author_facet Hu, Yue-Mei
Guo, Meng
Li, Chang-Gui
Chu, Kai
He, Wen-Gang
Zhang, Jing
Gu, Jian-Xiang
Li, Juan
Zhao, Hui
Wu, Xiang-Hong
Lin, BiZhen
Lin, Zhi-Jie
Yao, Xing-Mei
Li, Ya-Fei
Wei, FeiXue
Huang, Yue
Su, Ying-Ying
Zhu, Feng-Cai
Huang, Shou-Jie
Pan, Hui-Rong
Wu, Ting
Zhang, Jun
Xia, Ning-Shao
author_sort Hu, Yue-Mei
collection PubMed
description A new HPV-16/18 bivalent vaccine expressed by the Escherichia coli has been proven to be efficacious in adult women. A randomized, immunogenicity noninferiority study of this candidate vaccine was conducted in December 2015 in China. Girls aged 9–14 years were randomized to receive 2 doses at months 0 and 6 (n=301) or 3 doses at months 0, 1 and 6 (n=304). Girls aged 15–17 years (n=149) and women aged 18–26 years (n=225) received 3 doses. The objectives included noninferiority analysis of the IgG geometric mean concentration (GMC) ratio (95% CI, lower bound>0.5) to HPV-16 and HPV-18 at month 7 in girls compared with women. In the per-protocol set, the GMC ratio of IgG was noninferior for girls aged 9–17 years receiving 3 doses compared with women (1.76 (95% CI, 1.56, 1.99) for HPV-16 and 1.93 (95% CI, 1.69, 2.21) for HPV-18) and noninferior for girls aged 9–14 years receiving 2 doses compared with women (1.45 (95% CI, 1.25, 1.62) for HPV-16 and 1.17 (95% CI, 1.02, 1.33) for HPV-18). Noninferiority was also demonstrated for neutralizing antibodies. The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women. ELECTRONIC SUPPLEMENTARY MATERIAL: Supplementary material is available for this article at 10.1007/s11427-019-9547-7 and is accessible for authorized users.
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spelling pubmed-72233152020-05-15 Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women Hu, Yue-Mei Guo, Meng Li, Chang-Gui Chu, Kai He, Wen-Gang Zhang, Jing Gu, Jian-Xiang Li, Juan Zhao, Hui Wu, Xiang-Hong Lin, BiZhen Lin, Zhi-Jie Yao, Xing-Mei Li, Ya-Fei Wei, FeiXue Huang, Yue Su, Ying-Ying Zhu, Feng-Cai Huang, Shou-Jie Pan, Hui-Rong Wu, Ting Zhang, Jun Xia, Ning-Shao Sci China Life Sci Research Paper A new HPV-16/18 bivalent vaccine expressed by the Escherichia coli has been proven to be efficacious in adult women. A randomized, immunogenicity noninferiority study of this candidate vaccine was conducted in December 2015 in China. Girls aged 9–14 years were randomized to receive 2 doses at months 0 and 6 (n=301) or 3 doses at months 0, 1 and 6 (n=304). Girls aged 15–17 years (n=149) and women aged 18–26 years (n=225) received 3 doses. The objectives included noninferiority analysis of the IgG geometric mean concentration (GMC) ratio (95% CI, lower bound>0.5) to HPV-16 and HPV-18 at month 7 in girls compared with women. In the per-protocol set, the GMC ratio of IgG was noninferior for girls aged 9–17 years receiving 3 doses compared with women (1.76 (95% CI, 1.56, 1.99) for HPV-16 and 1.93 (95% CI, 1.69, 2.21) for HPV-18) and noninferior for girls aged 9–14 years receiving 2 doses compared with women (1.45 (95% CI, 1.25, 1.62) for HPV-16 and 1.17 (95% CI, 1.02, 1.33) for HPV-18). Noninferiority was also demonstrated for neutralizing antibodies. The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women. ELECTRONIC SUPPLEMENTARY MATERIAL: Supplementary material is available for this article at 10.1007/s11427-019-9547-7 and is accessible for authorized users. Science China Press 2019-06-21 2020 /pmc/articles/PMC7223315/ /pubmed/31231780 http://dx.doi.org/10.1007/s11427-019-9547-7 Text en © Science China Press and Springer-Verlag GmbH Germany, part of Springer Nature 2019 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Research Paper
Hu, Yue-Mei
Guo, Meng
Li, Chang-Gui
Chu, Kai
He, Wen-Gang
Zhang, Jing
Gu, Jian-Xiang
Li, Juan
Zhao, Hui
Wu, Xiang-Hong
Lin, BiZhen
Lin, Zhi-Jie
Yao, Xing-Mei
Li, Ya-Fei
Wei, FeiXue
Huang, Yue
Su, Ying-Ying
Zhu, Feng-Cai
Huang, Shou-Jie
Pan, Hui-Rong
Wu, Ting
Zhang, Jun
Xia, Ning-Shao
Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women
title Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women
title_full Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women
title_fullStr Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women
title_full_unstemmed Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women
title_short Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women
title_sort immunogenicity noninferiority study of 2 doses and 3 doses of an escherichia coli-produced hpv bivalent vaccine in girls vs. 3 doses in young women
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7223315/
https://www.ncbi.nlm.nih.gov/pubmed/31231780
http://dx.doi.org/10.1007/s11427-019-9547-7
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