PATH, Seattle, Washington.
J Infect Dis. 2013 Oct 15;208(8):1325-34. doi: 10.1093/infdis/jit363. Epub 2013 Jul 30.
Immune response to quadrivalent human papillomavirus (HPV) vaccine delivered at 0, 2, and 6 months in young adolescent females plateaus around 24 months after immunization. Antibody levels >24 months postvaccination using extended dosing schedules is unknown.
We conducted a follow-up immunogenicity study of adolescent girls in Vietnam who participated in a noninferiority trial to investigate whether immune responses using 3 alternative dosing schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months) are noninferior to the standard schedule at >2 years after immunization.
Quadrivalent HPV vaccine immunogenicity delivered on 3 alternative dosing schedules was noninferior for types 6, 11, 16, and 18 at 32 months post-dose 3 compared to the standard schedule. Pre-dose 3 antibody levels for the 0, 12, 24 month schedule were similar to those measured 32-months post-dose 3.
We found similar antibody concentrations ≥29 months after 3 doses of HPV vaccine regardless of dose-timing, and extended schedules do not produce inferior immune responses. Our findings also suggested that 2 doses of HPV vaccine delivered at 0 and 12 months might afford similar protection. Evidence supporting dosing flexibility could be important for national HPV vaccination policies.
在接种四价人乳头瘤病毒(HPV)疫苗 0、2 和 6 个月后,年轻少女的免疫反应在接种后 24 个月左右达到平台期。延长接种方案 24 个月后抗体水平尚不清楚。
我们对越南青少年女孩进行了一项随访免疫原性研究,这些女孩参加了一项非劣效性试验,以调查在接种后 2 年以上使用 3 种替代接种方案(0、3、9 个月;0、6、12 个月;或 0、12、24 个月)的免疫反应是否不劣于标准方案。
与标准方案相比,在接种第 3 剂后 32 个月时,3 种替代接种方案的四价 HPV 疫苗免疫原性对 6、11、16 和 18 型均不劣效。第 3 剂前的抗体水平与第 3 剂后 32 个月时的抗体水平相似。
我们发现,无论剂量时间如何,在接种 3 剂 HPV 疫苗后 29 个月以上,均可产生相似的抗体浓度,并且延长接种方案不会产生较差的免疫反应。我们的研究结果还表明,在 0 个月和 12 个月时接种 2 剂 HPV 疫苗可能提供相似的保护。支持剂量灵活性的证据对于国家 HPV 疫苗接种政策可能很重要。