Sustained immunogenicity of 2-dose human papillomavirus 16/18 AS04-adjuvanted vaccine schedules in girls aged 9-14 years: A randomized trial

Li Min Huang*, Thanyawee Puthanakit, Chiu Cheng-Hsun, Tang Ren-Bin, Tino Schwarz, Angelo Pellegrino, Susanna Esposito, Louise Frenette, Shelly McNeil, Paolo Durando, Paul Rheault, Carlo Giaquinto, Michael Horn, Karl Ulrich Petry, Klaus Peters, Toma Azhar, Peter Hillemanns, Stephanie De Simoni, Damien Friel, Suryakiran PemmarajuMarjan Hezareh, Florence Thomas, Dominique Descamps, Nicolas Folschweiller, Frank Struyf

*此作品的通信作者

研究成果: 期刊稿件文章同行評審

29 引文 斯高帕斯(Scopus)

摘要

Background. We previously reported the noninferiority 1 month after the last dose of 2-dose human papillomavirus 16/18 AS04-adjuvanted (AS04-HPV-16/18) vaccine schedules at months 0 and 6 (2D-M0, 6) and months 0 and 12 (2D-M0, 12) in girls aged 9-14 years compared with a 3-dose schedule at months 0, 1, and 6 (3D-M0, 1, 6) in women aged 15-25 years. Here, we report the results at study end (month 36 [M36]). Methods. Girls were randomized 1: 1 and received 2 vaccine doses either 6 months (2D-M0, 6) or 12 months apart (2D-M0, 12); women received 3 doses at months 0, 1, and 6 (3D-M0, 1, 6). Endpoints included noninferiority of HPV-16/18 antibodies for 2D- M0, 6 versus 3D-M0, 1, 6; 2D-M0, 12 versus 3D-M0, 1, 6; and 2D-M0, 12 versus 2D-M0, 6; and assessment of neutralizing antibodies, T cells, B cells, and safety. Results. At M36, the 2D-M0, 6 and 2D-M0, 12 schedules remained noninferior to the 3D-M0, 1, 6 schedule in terms of seroconversion rates and 3D/2D geometric mean titers for anti-HPV-16 and anti-HPV-18. All schedules elicited sustained immune responses up to M36. Conclusions. Both 2-dose schedules in young girls remained noninferior to the 3-dose schedule in women up to study conclusion at M36. The AS04-HPV-16/18 vaccine administered as a 2-dose schedule was immunogenic and well tolerated in young girls.

原文英語
頁(從 - 到)1711-1719
頁數9
期刊Journal of Infectious Diseases
215
發行號11
DOIs
出版狀態已出版 - 01 06 2017
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© The Author 2017.

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