Long-term persistence of immune response to the AS04-adjuvanted HPV-16/18 vaccine in Chinese girls aged 9-17 years: Results from an 8-9-year follow-up phase III open-label study

Yuemei Hu, Xiang Zhang, Yilin He, Zhilong Ma, Yan Xie, Xiangbin Lu, Yabin Xu, Yanqiu Zhang, Yunyu Jiang, Hui Xiao, Frank Struyf, Nicolas Folschweiller, Johny Jiang, Sylviane Poncelet, Naveen Karkada, Archana Jastorff, Dorota Borys, Yuemei Hu, Xiang Zhang, Yilin He, Zhilong Ma, Yan Xie, Xiangbin Lu, Yabin Xu, Yanqiu Zhang, Yunyu Jiang, Hui Xiao, Frank Struyf, Nicolas Folschweiller, Johny Jiang, Sylviane Poncelet, Naveen Karkada, Archana Jastorff, Dorota Borys

Abstract

Aim: In 9-17-year-old Chinese girls, the AS04-adjuvanted HPV-16/18 vaccine (AS04-HPV-16/18) given as three-dose schedule induced high antibody levels, which were noninferior 1 month after the third dose to those observed in 18-25-year-old Chinese women in a large efficacy study. We assessed the persistence of antibodies 8-9 years after vaccination in the same subjects.

Methods: This follow-up phase III, open-label study (NCT03355820) included subjects who had received three doses of AS04-HPV-16/18 in the initial trial (NCT00996125). Serum antibody concentrations were assessed by ELISA and compared to antibody persistence observed in 18-25-year-old Chinese women 6 years after first vaccination in the efficacy study (NCT00779766).

Results: Out of the 227 enrolled subjects, 223 were included in the per-protocol immunogenicity analysis. Mean interval from first AS04-HPV-16/18 dose to blood sampling was 101.4 months (8.5 years). For antibodies against HPV-16 and -18, 8.5 years after first vaccine dose all subjects remained seropositive and antibody. Geometric mean concentrations (GMCs) were 1236.3 (95% confidence interval [CI]: 1121.8; 1362.4) and 535.6 (95% CI: 478.6; 599.4) ELISA Units/mL, respectively. These seropositivity rates and antibody GMCs were higher than those observed 6 years after first vaccination of 18-25-year-old women.

Conclusion: Sustained anti-HPV-16 and -18 immune responses were observed 8-9 years after AS04-HPV-16/18 vaccination of 9-17 year-old Chinese girls that were higher than the ones observed 6 years after first vaccination in Chinese adult women in whom AS04-HPV-16/18 efficacy against cervical intraepithelial neoplasia of grade ≥2 was demonstrated.

Keywords: AS04-adjuvanted HPV-16/18 vaccine; China; cervical cancer; human papillomavirus; immunogenicity.

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: Frank Struyf, Nicolas Folschweiller, Johny Jiang, Sylviane Poncelet, Naveen Karkada, and Dorota Borys are employees of the GSK group of companies. Frank Struyf, Nicolas Folschweiller, Sylviane Poncelet, and Dorota Borys hold shares in the GSK group of companies. Archana Jastorff was consultant of XPE Pharma & Science for the GSK group of companies at the time the study was conducted. Yuemei Hu, Xiang Zhang, Yilin He, Zhilong MA, Yan Xie, Xiangbin Lu, Yabin Xu, Yanqiu Zhang, Yunyu Jiang, and Hui Xiao have nothing to disclose.

© 2020 The Authors. Asia-Pacific Journal of Clinical Oncology published by John Wiley & Sons Australia, Ltd.

Figures

FIGURE 1
FIGURE 1
Focus on the patient [Color figure can be viewed at wileyonlinelibrary.com]
FIGURE 2
FIGURE 2
Study design AS04‐HPV‐16/18: AS04‐adjuvanted HPV‐16/18 vaccine
FIGURE 3
FIGURE 3
CONSORT diagram. AS04‐HPV‐16/18 vaccine: AS04‐adjuvanted HPV‐16/18 vaccine. Abbreviation: N, number of subjects

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