Safety and immunogenicity of a bivalent HPV16/18 vaccine in Chinese females

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 (...

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Bibliographic Details
Published in:Human vaccines & immunotherapeutics 2023-12, Vol.19 (1), p.2209001-2209001
Main Authors: Shi, Li-Wei, Li, Juan, Yu, Bang-Wei, Huang, Li-Rong, Li, Ke, Ji, Min, Zhou, Ling-Yun, Yuan, Lin, Yang, Shu-Yuan, Chen, Jing-Jing, Wang, Ling, Jiang, Zhi-Wei, Li, Rong-Cheng, Li, Yan-Ping, Xia, Jie-Lai, Mo, Zhao-Jun, Li, Chang-Gui
Format: Article
Language:English
Subjects:
Adolescent
Adult
Antibodies, Neutralizing
Antibodies, Viral
Child
Double-Blind Method
East Asian People
Female
HPV
Human papilloma virus
Human papillomavirus 16
Human papillomavirus 18
Humans
immunogenicity
Immunogenicity, Vaccine
Middle Aged
neutralizing antibodies
Papillomavirus Infections - prevention & control
Papillomavirus Vaccines
reactogenicity
vaccine
Vaccines, Combined
Young Adult
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Summary: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. In vaccinees, 99.8% seroconverted for HPV 16 and 18 types at 7 months; respective GMTs of 5827 (95% CI: 5249, 6468) and 4223 (3785, 4713) were significantly (p 
ISSN:2164-5515
2164-554X
DOI:10.1080/21645515.2023.2209001