9至14岁女孩中，按照2剂和3剂接种程序接种人乳头瘤病毒（HPV）-16/18 AS04佐剂疫苗和HPV-6/11/16/18疫苗的免疫原性和安全性比较：一项随机试验至第12个月的结果
Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial.
作者信息
Leung Ting Fan, Liu Anthony Pak-Yin, Lim Fong Seng, Thollot Franck, Oh Helen May Lin, Lee Bee Wah, Rombo Lars, Tan Ngiap Chuan, Rouzier Roman, Friel Damien, De Muynck Benoit, De Simoni Stéphanie, Suryakiran Pemmaraju, Hezareh Marjan, Folschweiller Nicolas, Thomas Florence, Struyf Frank
机构信息
a Department of Paediatrics ; The Chinese University of Hong Kong ; Shatin , Hong Kong.
出版信息
Hum Vaccin Immunother. 2015;11(7):1689-702. doi: 10.1080/21645515.2015.1050570.
This observer-blind study (clinicaltrials.gov NCT01462357) compared the immunogenicity and safety of 2 doses of the HPV-16/18 AS04-adjuvanted vaccine (HPV-16/18(2D)) vs. 2 or 3 doses of the HPV-6/11/16/18 vaccine (HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D)) in healthy girls aged 9-14 y. Girls were randomized (1:1:1) to receive HPV-16/18(2D) at months (M) 0,6 (N = 359), HPV-6/11/16/18(2D) at M0,6 (N = 358) or HPV-6/11/16/18(3D) at M0,2,6 (N = 358). The primary objective was non-inferiority/superiority of HPV-16/18 antibodies by ELISA for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) at M7 in the according-to-protocol immunogenicity cohort (ATP-I) and total vaccinated cohort, respectively. Secondary objectives included non-inferiority/superiority of HPV-16/18(2D) vs. HPV-6/11/16/18(3D) at M7, non-inferiority/superiority at M12, HPV-16/18 neutralizing antibodies, frequencies of T-cells/B-cells, reactogenicity and safety. Antibody responses at M7 for HPV-16/18(2D) were superior to those for HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) (lower limit of 95% confidence interval for geometric mean titer ratio (GMR) was >1): HPV-16/18(2D)/HPV-6/11/16/18(2D) GMRs were 1.69 [1.49-1.91] for anti-HPV-16 and 4.52 [3.97-5.13] for anti-HPV-18; HPV-16/18(2D)/HPV-6/11/16/18(3D) GMRs were 1.72 [1.54-1.93] for anti-HPV-16 and 3.22 [2.82-3.68] for anti-HPV-18; p = 0.0001 for all comparisons. Non-inferiority/superiority was also demonstrated at M12. Among initially seronegative girls in the ATP-I, neutralizing antibody titers were at least 1.8-fold higher for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) at M7 and M12. Frequencies of HPV-16/18-specific T-cells and B-cells were in similar ranges between groups. Reactogenicity and safety were in line with the known profile of each vaccine. In conclusion, superior HPV-16/18 antibody responses were elicited by 2 doses of the HPV-16/18 AS04-adjuvanted vaccine compared with 2 or 3 doses of the HPV-6/11/16/18 vaccine in girls (9-14 years).
这项观察者盲法研究（clinicaltrials.gov NCT01462357）比较了2剂HPV-16/18 AS04佐剂疫苗（HPV-16/18(2D)）与2剂或3剂HPV-6/11/16/18疫苗（HPV-6/11/16/18(2D)和HPV-6/11/16/18(3D)）在9至14岁健康女孩中的免疫原性和安全性。女孩们被随机分组（1:1:1），分别在0月、6月接种HPV-16/18(2D)（N = 359），在0月、6月接种HPV-6/11/16/18(2D)（N = 358），或在0月、2月、6月接种HPV-6/11/16/18(3D)（N = 358）。主要目标是在符合方案免疫原性队列（ATP-I）和总接种队列中，通过ELISA法比较HPV-16/18(2D)与HPV-6/11/16/18(2D)在第7个月时HPV-16/18抗体的非劣效性/优效性。次要目标包括HPV-16/18(2D)与HPV-6/11/16/18(3D)在第7个月时的非劣效性/优效性、第12个月时的非劣效性/优效性、HPV-16/18中和抗体、T细胞/B细胞频率、反应原性和安全性。HPV-16/18(2D)在第7个月时的抗体反应优于HPV-6/11/16/18(2D)和HPV-6/11/16/18(3D)（几何平均滴度比值（GMR）的95%置信区间下限>1）：HPV-16/18(2D)/HPV-6/11/16/18(2D)的抗HPV-16 GMR为1.69[1.49 - 1.91]，抗HPV-18 GMR为4.52[3.97 - 5.13]；HPV-16/18(2D)/HPV-6/11/16/18(3D)的抗HPV-16 GMR为1.72[1.54 - 1.93]，抗HPV-18 GMR为3.22[2.82 - 3.68]；所有比较的p = 0.0001。在第12个月时也证明了非劣效性/优效性。在ATP-I中最初血清阴性的女孩中，HPV-16/18(2D)在第7个月和第12个月时的中和抗体滴度比HPV-6/11/16/18(2D)和HPV-6/11/16/18(3D)至少高1.8倍。HPV-16/18特异性T细胞和B细胞的频率在各组之间处于相似范围。反应原性和安全性与每种疫苗已知的情况一致。总之，与2剂或3剂HPV-6/11/16/18疫苗相比，2剂HPV-16/18 AS04佐剂疫苗在（9至14岁）女孩中引发了更强的HPV-16/18抗体反应。
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