Li-Wei Shi, Juan Li, Bang-Wei Yu, Li-Rong Huang, Ke Li, Min Ji, Ling-Yun Zhou, Lin Yuan, Shu-Yuan Yang, Jing-Jing Chen, Ling Wang, Zhi-Wei Jiang, Rong-Cheng Li, Yan-Ping Li, Jie-Lai Xia, Zhao-Jun Mo, Chang-Gui Li
As global supply is still inadequate to address the worldwide requirements for HPV vaccines, we assessed the safety and immunogenicity of a new bivalent HPV16/18 vaccine. In this randomized, double-blind, placebo-controlled, phase 2 trial, healthy 9-45-year-old Chinese females in three age cohorts (600 aged 9-17 years; 240 aged 18-26 years; 360 aged 27-45 years) were randomized 1:1 to receive three doses (0,2,6 months) of HPV16/18 vaccine or placebo. We measured neutralizing antibodies against HPV 16 and 18 at 7 months and monitored safety to 12 months in all age cohorts; 9-17-year-old girls were monitored for safety and immunogenicity to 48 months...
May 30, 2023: Human Vaccines & Immunotherapeutics