Huang Li-Min, Puthanakit Thanyawee, Cheng-Hsun Chiu, Ren-Bin Tang, Schwarz Tino, Pellegrino Angelo, Esposito Susanna, Frenette Louise, McNeil Shelly, Durando Paolo, Rheault Paul, Giaquinto Carlo, Horn Michael, Petry Karl Ulrich, Peters Klaus, Azhar Toma, Hillemanns Peter, De Simoni Stephanie, Friel Damien, Pemmaraju Suryakiran, Hezareh Marjan, Thomas Florence, Descamps Dominique, Folschweiller Nicolas, Struyf Frank
Department of Pediatrics, National Taiwan University Children's Hospital, National Taiwan University, Taipei.
Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, and Research Unit in Pediatric Infectious Diseases and Vaccines, Chulalongkorn University, Thailand.
J Infect Dis. 2017 Jun 1;215(11):1711-1719. doi: 10.1093/infdis/jix154.
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]).
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.
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.
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.
我们之前报道了在9至14岁女孩中，与15至25岁女性在0、1和6月接种3剂（3D_M0,1,6）的方案相比，在0月和6月（2D_M0,6）以及0月和12月（2D_M0,12）接种2剂人乳头瘤病毒16/18 AS04佐剂（AS04-HPV-16/18）疫苗方案最后一剂后1个月的非劣效性。在此，我们报告研究结束时（第36个月[M36]）的结果。
女孩按1:1随机分组，接种2剂疫苗，间隔6个月（2D_M0,6）或12个月（2D_M0,12）；女性在0、1和6月接种3剂（3D_M0,1,6）。终点包括2D_M0,6与3D_M0,1,6相比、2D_M0,12与3D_M0,1,6相比以及2D_M0,12与2D_M0,6相比时HPV-16/18抗体的非劣效性；以及中和抗体、T细胞、B细胞的评估和安全性评估。
在M36时，就抗HPV-16和抗HPV-18的血清转化率和3D/2D几何平均滴度而言，2D_M0,6和2D_M0,12方案仍不劣于3D_M0,1,6方案。所有方案在M36时均引发了持续的免疫反应。
直至M36的研究结束，年轻女孩中的两种2剂方案仍不劣于女性中的3剂方案。以2剂方案接种的AS04-HPV-16/18疫苗在年轻女孩中具有免疫原性且耐受性良好。
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