An assessment of prime-boost vaccination schedules with AS03A-adjuvanted prepandemic H5N1 vaccines: a randomized study in European adults
An assessment of prime-boost vaccination schedules with AS03A-adjuvanted prepandemic H5N1 vaccines: a randomized study in European adults
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DOI：
10.1111/j.1750-2659.2012.00349.x
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发表时间：
2013-01-01
影响因子：
4.4
通讯作者：
Schwarz, Tino F.
中科院分区：
文献类型：
--
作者：
Gillard, Paul;Caplanusi, Adrian;Schwarz, Tino F.
请引用本文：Gillard等人。(2012)对AS03A佐剂的流行前H5N1疫苗的主要强化免疫计划的评估：一项在欧洲成年人中的随机研究。流感和其他呼吸道病毒DOI：10.1111/j.1750-2659.2012.00349.x.背景使用模拟潜在大流行情景的各种主要增强方案评估了使用AS03(一种基于α-生育酚水包油乳剂的佐剂系统)佐剂的H5N1流行前流感疫苗的免疫反应的长期持久性和安全性(NCT00430521)。方法对512名1860岁健康成人接种甲型H5N1疫苗一剂或两剂(0，21天计划)，6个月或12个月后再接种A/越南/1194/2004或A/印度尼西亚/05/2005株疫苗。通过血凝抑制[HI]试验、微量中和试验和细胞免疫应答(CMI)试验，报告了4组在12个月时加强免疫的结果。结果12个月后，一剂佐剂一次免疫，随后一剂含有异种疫苗毒株的单剂佐剂佐剂达到或超过了美国和欧洲对两种毒株的所有标准。增加第一次和第二次接种之间的间隔(从21天增加到12个月)导致对A/印度尼西亚/05/2005毒株的更强的交叉反应免疫反应。对这两种毒株的HI抗体反应在加强剂量后持续6个月，与加强疫苗株无关。在研究人群中观察到的中和抗体反应和CMI与HI免疫反应是平行的。总体而言，该疫苗具有临床可接受的安全性。结论本研究中的H5N1疫苗允许在初次接种和加强接种之间的时间间隔以及使用异源毒株之间的灵活性，而不影响对这两种疫苗毒株的体液和细胞免疫反应的强度。
Please cite this paper as: Gillard et al. (2012) An assessment of prime-boost vaccination schedules with AS03A-adjuvanted prepandemic H5N1 vaccines: a randomized study in European adults. Influenza and Other Respiratory Viruses DOI: 10.1111/j.1750-2659.2012.00349.x. Background Long-term persistence of immune response and safety of an H5N1 prepandemic influenza vaccine adjuvanted with AS03 (an a-tocopherol oil-in-water emulsion-based adjuvant system) was evaluated using various prime-boost schedules that mimicked potential pandemic scenarios (NCT00430521). Methods Five hundred and twelve healthy adults aged 1860 years received primary vaccination with one or two doses (0, 21 days schedule) of the A/Vietnam/1194/2004 H5N1 vaccine followed by a booster dose (A/Vietnam/1194/2004 or A/Indonesia/05/2005 strain) six or twelve months later across eight randomized groups. Immunogenicity results by hemagglutination inhibition [HI] assay, microneutralization assay, and the cell-mediated immune response (CMI) are reported here for the four groups boosted at Month 12. Results A one-dose-adjuvanted primary administration followed 12 months later by a single-adjuvanted booster dose containing a heterologous vaccine strain met or exceeded all US and European criteria for both strains. Increasing the interval between the first and second dose (from 21 days to 12 months) resulted in stronger cross-reactive immune responses against the A/Indonesia/05/2005 strain. The HI antibody response against the two strains persisted for 6 months after the booster dose irrespective of the booster vaccines strain. The neutralizing antibody responses and the CMI observed in the study population paralleled the HI immune response. Overall, the vaccine had a clinically acceptable safety profile. Conclusion The H5N1 vaccine in this study allowed for flexibility in the time interval between primary and booster vaccination and the use of a heterologous strain without impacting the strength of the humoral and cellular immune response to both vaccine strains.