Details

Autor(en) / Beteiligte

• 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

Titel

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

Ist Teil von

• Science China. Life sciences, 2020-04, Vol.63 (4), p.582-591

Ort / Verlag

Beijing: Science China Press

Erscheinungsjahr

2020

Link zum Volltext

Quelle

Springer Journals

Beschreibungen/Notizen

• 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.