Immunogenicity profile of a 3.75-μg hemagglutinin pandemic rH5N1 split virion AS03A-adjuvanted vaccine in elderly persons: a randomized trial.
Immunogenicity profile of a 3.75-μg hemagglutinin pandemic rH5N1 split virion AS03A-adjuvanted vaccine in elderly persons: a randomized trial.
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DOI：
10.1093/infdis/jiq174
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发表时间：
2011-04-15
期刊：
影响因子：
--
通讯作者：
Gillard P
中科院分区：
文献类型：
--
作者：
Heijmans S;De Meulemeester M;Reynders P;Giet D;Demanet E;Devresse PY;Icardi G;Dramé M;Roman F;Gillard P
背景：老年人对流感疫苗接种的免疫应答常常降低。 我们评估了AS 03 A佐剂H5 N1大流行疫苗（3.75 μg A/Vietnam/1194/2004样毒株血凝素）的常规剂量与老年人群中双倍剂量的比较。方法：这项2期、开放标签研究（NCT 00397215; http://www.clinicaltrials.gov）将受试者（年龄≥61岁）随机分组，在第0天和第21天接受：（1）单剂AS 03 A佐剂疫苗（n = 152），（2）单剂无佐剂疫苗（n = 54），（3）双剂AS 03 A佐剂疫苗（n = 145），或（4）双剂无佐剂疫苗（n = 44）。 主要终点是血凝抑制（HI）和针对疫苗抗原的中和抗体应答（符合方案队列）。结果：第42天，单剂量和双剂量AS 03 A佐剂疫苗HI抗体的几何平均滴度分别为126.8和237.3。 中和抗体的相应值为447.3和595.8。尽管双倍剂量的免疫应答更高，但两个AS 03 A佐剂组均达到了欧洲人用药品委员会的血清转化率和血清保护率标准。引发抗原特异性CD 4 T细胞应答。6个月时的免疫应答持续性较高。 AS 03 A佐剂H5 N1疫苗可以以与年轻人相同的剂量和时间表给予老年人。
Background. Elderly persons often experience a reduced immune response to influenza vaccination. We evaluated the usual dose of AS03A-adjuvanted H5N1 pandemic vaccine (3.75 μg hemagglutinin of A/Vietnam/1194/2004-like strain) compared with a double dose in an elderly population. Methods. This phase 2, open-label study (NCT00397215; http://www.clinicaltrials.gov) randomized participants (age, ≥61 years) to receive, on days 0 and 21: (1) a single dose of AS03A-adjuvanted vaccine (n = 152), (2) a single dose of nonadjuvanted vaccine (n = 54), (3) a double dose of AS03A-adjuvanted vaccine (n = 145), or (4) a double dose of nonadjuvanted vaccine (n = 44). The primary end point was hemagglutination inhibition (HI) and neutralizing antibody response against vaccine antigen (according-to-protocol cohort). Results. Day 42 geometric mean titers for HI antibodies were 126.8 and 237.3 for single and double doses of the AS03A-adjuvanted vaccine, respectively. Corresponding values for neutralizing antibodies were 447.3 and 595.8. Although the immune response was higher with the double dose, European Committee for Human Medicinal Products criteria for seroconversion and seroprotection rates were achieved in both AS03A-adjuvanted groups. Antigen-specific CD4 T cell responses were elicited. Immune response persistence at 6 months was high. Immune response in the non-adjuvanted groups was considerably less. Conclusions. The AS03A-adjuvanted H5N1 vaccine can be administered elderly persons at the same dose and schedule as in younger adults.
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