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1Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs.3 doses in young women显示文摘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.Yue-Mei Hu Meng Guo Chang-Gui Li Kai Chu Wen-Gang He Jing Zhang Jian-Xiang Gu Juan Li Hui Zhao Xiang-Hong Wu Bi-Zhen Lin Zhi-Jie Lin Xing-Mei Yao Ya-Fei Li Fei-Xue Wei Yue Huang Ying-Ying Su Feng-Cai Zhu Shou-Jie Huang Hui-Rong Pan Ting Wu Jun Zhang Ning-Shao Xia 2020Science China(Life Sciences)2020,63,4:19
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