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  

作　　者：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 

机构地区：[1]Jiangsu Provincial Center for Disease Control and Prevention,Nanjing 210009,China [2]The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics,National Institute of Diagnostics and Vaccine Development in Infectious Diseases,Collaborative Innovation Center of Biologic Products,School of Public Health,Xiamen University,Xiamen 361102,China [3]National Institute for Food and Drug Control,Beijing 102629,China [4]Sheyang Center for Disease Control and Prevention,Sheyang 244300,China [5]Xiamen Innovax Biotech Company,Xiamen 361022,China

出　　处：《Science China(Life Sciences)》2020年第4期582-591,共10页中国科学（生命科学英文版）

基　　金：This work was supported by the National Natural Science Foundation of China(81673240,and U1705283);the Chinese National Major Scientific and Technological Special Project for“Significant New Drugs Development”(2018ZX09308010,2012ZX09101316);the Fujian Provincial Major Scientific and Technological Project(2015YZ0002)and Xiamen Innovax.

摘　　要：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.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.

关 键 词：immunobridging NONINFERIORITY human PAPILLOMAVIRUS vaccine ESCHERICHIA COLI GIRLS 

分 类 号：R186[医药卫生—流行病学]