Serum antibody responses after intradermal vaccination against influenza
Serum antibody responses after intradermal vaccination against influenza
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DOI：
10.1056/nejmoa043555
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发表时间：
2004-11-25
影响因子：
158.5
通讯作者：
Dubin, G
中科院分区：
文献类型：
--
作者：
Belshe, RB;Newman, FK;Dubin, G
背景：如果经皮内途径接种的流感疫苗安全且具有免疫原性，则减少疫苗剂量可增加疫苗可用剂量。方法：在一项开放标签研究中，我们随机分配119名受试者接受皮内注射三价灭活流感疫苗，每种抗原含有6杯血凝素（常规剂量的40%），119名受试者接受肌肉注射标准剂量，每种抗原含有15杯血凝素。两组按年龄再细分（18 ~ 60岁和60岁以上）。结果在18 ~ 60岁的受试者中，血清抗体反应强烈，皮内注射组和肌肉注射组之间无显著差异，所有受试者的血凝抑制（HAI）滴度至少为1:40。虽然60岁以上的受试者也有强烈的抗体应答，但在肌肉注射途径有更好的应答趋势，但这一发现仅对H3N2株抗原有意义。然而，肌肉注射组中100%的老年受试者和皮内注射组中93%的老年受试者对H3N2株的HAI抗体滴度大于1:40，并且两组中100%的人对H1N1和B株的滴度都达到这个水平。局部疼痛在18 - 60岁的受试者中肌肉注射组明显比皮内注射组更常见，而在60岁以上的受试者中则没有。在两个年龄组中，皮内注射组的局部炎症症状明显比肌肉注射组更常见。结论：与肌肉注射全剂量流感疫苗相比，皮内注射减少剂量在18至60岁人群中产生了同样强烈的抗体反应，而在60岁以上人群中则没有。
BACKGROUNDIf found to be safe and immunogenic, reduced doses of influenza vaccine given by the intradermal route could increase the number of available doses of vaccine.METHODSIn an open-label study, we randomly assigned 119 subjects to receive an intradermal injection of trivalent inactivated influenza vaccine, containing 6 mug of hemagglutinin for each antigen ( 40 percent of the usual dose), and 119 to receive an intramuscular injection of the standard dose of 15 mug of hemagglutinin for each antigen. The two groups were subdivided according to age ( 18 to 60 years and older than 60 years).RESULTSAmong subjects who were 18 to 60 years of age, serum antibody responses were vigorous and did not differ significantly between the intradermal and intramuscular groups, and all subjects had hemagglutination-inhibition (HAI) titers of at least 1: 40. Although the subjects who were older than 60 years of age also had a vigorous antibody response, there was a trend toward a better response in the intramuscular route, but this finding was significant only for antigen to the H3N2 strain. Nevertheless, 100 percent of older subjects in the intramuscular group and 93 percent of such subjects in the intradermal group had an HAI antibody titer to the H3N2 strain of more than 1: 40, and 100 percent in each group had a titer of this level for both the H1N1 and B strains. Local pain was significantly more common in the intramuscular group than in the intradermal group among subjects who were 18 to 60 years of age but not among subjects who were over 60 years old. Signs of local inflammation were significantly more common among subjects in the intradermal group than among those in the intramuscular group, in both age groups.CONCLUSIONSAs compared with an intramuscular injection of full-dose influenza vaccine, an intradermal injection of a reduced dose resulted in similarly vigorous antibody responses among persons 18 to 60 years of age but not among those over the age of 60 years.