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Immunogenicity and safety of the 9-valent human papillomavirus vaccine in Chinese females 9-45 years of age: A phase 3 open-label study.
Lv, Huakun; Wang, Shenyu; Liang, Zhenzhen; Yu, Wei; Yan, Chuanfu; Chen, Yingping; Hu, Xiaosong; Fu, Rong; Zheng, Minghuan; Group, Thomas; Luxembourg, Alain; Liao, Xueyan; Chen, Zhiping.
Afiliação
  • Lv H; Zhejiang Provincial Center for Disease Control and Prevention, Zhejiang, China. Electronic address: hklv@cdc.zj.cn.
  • Wang S; Zhejiang Provincial Center for Disease Control and Prevention, Zhejiang, China. Electronic address: sywang@cdc.zj.cn.
  • Liang Z; Zhejiang Provincial Center for Disease Control and Prevention, Zhejiang, China. Electronic address: zzliang@cdc.zj.cn.
  • Yu W; Keqiao District Center for Disease Control and Prevention, Zhejiang, China. Electronic address: 123930980@qq.com.
  • Yan C; Kaihua County Center for Disease Control and Prevention, Zhejiang, China. Electronic address: 379283470@qq.com.
  • Chen Y; Zhejiang Provincial Center for Disease Control and Prevention, Zhejiang, China. Electronic address: yingpchen@cdc.zj.cn.
  • Hu X; Zhejiang Provincial Center for Disease Control and Prevention, Zhejiang, China. Electronic address: xshu@cdc.zj.cn.
  • Fu R; MSD R&D (China) Co., Ltd., Beijing, China. Electronic address: rong.fu1@merck.com.
  • Zheng M; MSD R&D (China) Co., Ltd., Beijing, China. Electronic address: ming.huan.zheng@merck.com.
  • Group T; Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: thomas_group@merck.com.
  • Luxembourg A; Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: alain_luxembourg@merck.com.
  • Liao X; MSD R&D (China) Co., Ltd., Beijing, China. Electronic address: xue.yan.liao@merck.com.
  • Chen Z; Zhejiang Provincial Center for Disease Control and Prevention, Zhejiang, China. Electronic address: zhpchen@cdc.zj.cn.
Vaccine ; 40(23): 3263-3271, 2022 05 20.
Article em En | MEDLINE | ID: mdl-35487814
ABSTRACT

BACKGROUND:

The 9-valent human papillomavirus (9vHPV; HPV6/11/16/18/31/33/45/52/58) vaccine was approved for use in Chinese women aged 16-26 years in 2018. This phase 3, open-label study (NCT03903562) compared 9vHPV vaccine immunogenicity and safety in Chinese females aged 9-19 years and 27-45 years with Chinese females aged 20-26 years; we report results from day 1 through 1 month post-Dose 3. The study will continue through 54 months post-Dose 3 to assess antibody persistence in Chinese girls aged 9-19 years.

METHODS:

Participants aged 9-45 years received three doses of the 9vHPV vaccine. Geometric mean titers (GMTs) and seroconversion percentages for anti-HPV6/11/16/18/31/33/45/52/58 antibodies were determined by competitive Luminex immunoassay in serum samples obtained at day 1 and 1 month post-Dose 3. Adverse events (AEs) within 30 days post-vaccination and serious AEs (SAEs) occurring at any time were recorded.

RESULTS:

In total, 1990 participants (690 aged 9-19 years; 650 aged 20-26 years; 650 aged 27-45 years) were enrolled. At 1 month post-Dose 3, >99% of participants in the per-protocol immunogenicity population seroconverted to each vaccine HPV type. Anti-HPV6/11/16/18/31/33/45/52/58 antibody GMTs in the 9-19-year age group were non-inferior to those in participants aged 20-26 years. Anti-HPV6/11/16/18/31/33/45/52/58 seroconversion percentages in the 27-45-year age group were non-inferior to those in participants aged 20-26 years. Injection-site and systemic AEs were reported by 43.3% and 50.9%, 50.5% and 57.1%, and 43.8% and 43.4% of participants aged 9-19, 20-26, and 27-45 years, respectively. There were no vaccine-related SAEs, discontinuations due to AEs, and deaths.

CONCLUSION:

Antibody responses induced by 9vHPV vaccination in Chinese females aged 9-19 years and 27-45 years were non-inferior to those in Chinese females aged 20-26 years. The vaccine was generally well tolerated. CLINICALTRIALS gov Identifier NCT03903562.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções por Papillomavirus / Vacinas contra Papillomavirus Tipo de estudo: Guideline Limite: Adolescent / Adult / Child / Female / Humans / Middle aged País/Região como assunto: Asia Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções por Papillomavirus / Vacinas contra Papillomavirus Tipo de estudo: Guideline Limite: Adolescent / Adult / Child / Female / Humans / Middle aged País/Região como assunto: Asia Idioma: En Ano de publicação: 2022 Tipo de documento: Article