Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule Results from a randomized study
Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule Results from a randomized study
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DOI：
10.4161/hv.7.12.18322
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发表时间：
2011-12-01
期刊：
影响因子：
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通讯作者：
Descamps, Dominique
中科院分区：
文献类型：
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作者：
Romanowski, Barbara;Schwarz, Tino F.;Descamps, Dominique
人乳头瘤病毒(HPV)-16/18 AS 04佐剂疫苗(Cervarx(C)，GlaxoSmithKline Biologics)按照其许可的疫苗接种计划(3剂，3D)和配方(每个HPV抗原20微克；20/20F)接种，先前已证明具有免疫原性。这项部分盲法、对照、随机试验(NCT00541970)评估了使用许可的20/20F或包含每个抗原40微克(40/40F)的替代配方的2剂(2D)方案，并与许可的3D方案进行了比较。按年龄(9-14岁，15-19岁，20-25岁)分层的健康女性被随机分成两组，分别在男性0、6(n=240)、M0、6(n=241)或M0、2(n=240)月接受2剂20/20F或在M0、1、6接受3剂20/20F(获得许可的时间表/配方，n=239)。最后一次注射后1个月，3D方案的免疫学效果并不优于2D方案，但HPV-16的40/40FM0，2组(95%CI几何平均抗体滴度(GMT)比率的下限[2D/3D]和lt；0.5)除外。对于HPV-16和HPV-18，9-14岁女孩的2D计划在免疫上不逊于15-25岁女性(已证明有效的年龄组)的3D计划(GMT比率[3D/2D]和lt；2的上限95%CI)。在24个月时，9-14岁女孩的2D M0，6个时间表与15-25岁女性的3D时间表相比，保持了非劣势。所有配方都具有可接受的反应性和安全性。这些结果表明，2D M0，6方案的HPV-16/18疫苗具有免疫原性，在9-14岁的女孩中一般耐受性良好，2D方案可能适合年轻女性。
The immunogenicity of the human papillomavirus (HPV)-16/18 AS 04-adjuvanted vaccine (Cervarix (c), GlaxoSmithKline Biologicals) administered according to its licensed vaccination schedule (3-dose, 3D) and formulation (20 mu g of each HPV antigen; 20/20F) has previously been demonstrated. This partially-blind, controlled, randomized trial (NCT00541970) evaluated 2-dose (2D) schedules using the licensed 20/20F or an alternative formulation containing 40 mu g of each antigen (40/40F), compared with the licensed 3D schedule. Healthy females stratified by age (9-14, 15-19, 20-25 y) were randomized to receive 2 doses of 20/20F at Months (M) 0,6 (n = 240), 40/40F at M0,6 (n = 241) or 40/40F at M0,2 (n = 240), or 3 doses of 20/20F at M0,1,6 (licensed schedule/formulation, n = 239). One month after the last dose, the 3D schedule was not immunologically superior to 2D schedules except in the 40/40F M0,2 group for HPV-16 (lower limit of 95% CI geometric mean antibody titer (GMT) ratio [2D/3D] < 0.5). For both HPV-16 and HPV-18, the 2D schedules in girls 9-14 y were immunologically non-inferior to the 3D schedule in women 15-25 y (the age group in which efficacy has been demonstrated) (upper limit of 95% CI for GMT ratio [3D/2D] < 2) one month after the last dose. At Month 24, non-inferiority was maintained for the 2D M0,6 schedules in girls 9-14 y vs. the 3D schedule in women 15-25 y. All formulations had acceptable reactogenicity and safety profiles. These results indicate that the HPV-16/18 vaccine on a 2D M0,6 schedule is immunogenic and generally well tolerated in girls 9-14 y and that the 2D schedule is likely adequate for younger females.