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Randomized Controlled Trial
. 2021 Apr 3;17(4):955-964.
doi: 10.1080/21645515.2020.1829411. Epub 2020 Nov 12.

Efficacy of the AS04-adjuvanted HPV-16/18 vaccine in young Chinese women with oncogenic HPV infection at baseline: post-hoc analysis of a randomized controlled trial

Shangying Hu  1 , Xiaoqian Xu  1 , Fengcai Zhu  2 , Ying Hong  3 , Yuemei Hu  2 , Xun Zhang  1 , Qinjing Pan  1 , Wenhua Zhang  1 , Chengfu Zhang  4 , Xiaoping Yang  5 , Jiaxi Yu  6 , Jiahong Zhu  4 , Yejiang Zhu  7 , Feng Chen  1 , Shuang Zhao  1 , Naveen Karkada  8 , Haiwen Tang  9 , Dan Bi  8 , Frank Struyf  10 , Fanghui Zhao  1
Affiliations
Randomized Controlled Trial

Efficacy of the AS04-adjuvanted HPV-16/18 vaccine in young Chinese women with oncogenic HPV infection at baseline: post-hoc analysis of a randomized controlled trial

Shangying Hu et al. Hum Vaccin Immunother. .

Abstract

Human papillomavirus (HPV) vaccines are efficacious against HPV infections and associated lesions in women HPV-naïve at vaccination. However, vaccine efficacy (VE) against oncogenic, high-risk HPV (HR-HPV) types in women infected with any other HR-HPV type at first vaccination (baseline) remains unclear. This post-hoc analysis of a phase II/III study (NCT00779766) evaluated AS04-adjuvanted HPV-16/18 (AS04-HPV-16/18) VE against HR-HPV type infection in 871 Chinese women aged 18-25 years over a 72-month follow-up period. Study participants were DNA-negative at baseline to HR-HPV type(s) considered for VE and DNA-positive to any other HR-HPV type. Initial serostatus was not considered. Baseline DNA prevalence was 14.6% for any HR-HPV type and 10.6% excluding HPV-16/18. In the total vaccinated cohort for efficacy, VE against 6-month and 12-month HPV-16/18 persistent infections (PIs) in women DNA-negative to HPV-16/18 but DNA-positive to any other HR-HPV type at baseline was 100.0% (95% Confidence Interval [CI]: 79.8-100.0) and 100.0% (95%CI: 47.2-100.0), respectively. VE against HPV-16/18 incident infections in women DNA-positive to one vaccine type but DNA-negative to the other one at baseline was 66.8% (95%CI: -18.9-92.5). VE against HPV-31/33/45 incident infections, in women DNA-positive to HPV-16/18 and DNA-negative to the considered HPV type at baseline was 71.0% (95%CI: 27.3-89.8). No HPV-16/18 PIs were observed in vaccinated women with non-vaccine HPV A7/A9 species cervical infection at baseline. These findings indicated that women with existing HR-HPV infection at vaccination might still benefit from the AS04-HPV-16/18 vaccine. However, this potential benefit needs further demonstration in the future.

Keywords: China; Human papillomavirus; cervical cancer; clinical trial; efficacy; infection; prevention; vaccines.

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Conflict of interest statement

All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf and declare the following potential conflicts of interest: The institutions of Fang-Hui Zhao, Shangying Hu, Ying Hong, Yue-Mei Hu, Xun Zhang, Qin-Jing Pan, Wen-Hua Zhang, Cheng-Fu Zhang, Xiaoping Yang, Jia-Xi Yu, Jiahong Zhu, Yejiang Zhu, Feng Chen, Xiaoqian Xu, Shuang Zhao and Feng-Cai Zhu received grants/investigator fees from the GSK group of companies for the conduct and follow-up of this study. Fang-Hui Zhao, Feng-Cai Zhu and Yue-Mei Hu received support for travel to meetings related to the study from the GSK group of companies. Naveen Karkada, Haiwen Tang, Dan Bi are employees of the GSK group of companies. Frank Struyf was an employee of the GSK group of companies at the time the study was performed and is currently an employee of Janssen, Pharmaceutical companies of Johnson & Johnson. Haiwen Tang, Dan Bi, and Frank Struyf hold shares in the GSK group of companies.

Figures

Figure 1.
Figure 1.
Plain language summary
Figure 2.
Figure 2.
Analysis flowchart
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