Dose sparing intradermal trivalent influenza (2010/2011) vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain
Dose sparing intradermal trivalent influenza (2010/2011) vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain
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DOI：
10.1016/j.vaccine.2012.08.014
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发表时间：
2012-10-05
期刊：
影响因子：
5.5
通讯作者：
Yuen, Kwok-Yung
中科院分区：
文献类型：
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作者：
Hung, Ivan F. N.;Levin, Yotam;Yuen, Kwok-Yung
背景资料：我们假设，在老年人和慢性病患者中，由ESTJet 600（TM）（NanoPass Technologies，Israel）递送的三价流感疫苗（TIV）的低剂量皮内接种不劣于全剂量肌内和中剂量Intanza（R）接种。受试者随机分为4组。组ID 3和ID 9接受由NAPJet 600（TM）（NanoPass Technologies，Israel）递送的降低剂量的ID TIV（每株分别为3 μ g和9 μ g血凝素（HA））。组INT 9接受由Becton Dickinson的Soluvia（TM）装置（Intanza（R）9，Sanofi-Pasteur，France）递送的减少剂量ID TIV（9 μ g）。对照组IM 15接受全剂量IM TIV（15 μ g）。我们在基线和第21天通过血凝抑制（HAI）和微量中和（MN）测定抗体滴度。结果：所有组的基线特征相似（组和样本量：ID 3 = 63; ID 9 = 68; INT 9 = 65;和IM 15 = 66）。接种后第21天，ID疫苗组所有3个菌株的GMT比率和血清转换率差异均非劣效于IM疫苗组。与全剂量IM疫苗组相比，ID组的H1N1毒株的HAI和MN检测的血清转换率、血清保护率和GMT显著更高。与全剂量IM组相比，ID组中H3 N2毒株的HAI测定血清转化率也显著更高。三个ID组之间的直接比较显示无显著差异。结论：剂量节省ID TIV可以克服H1N1毒株的免疫原性降低，并根据某些措施，为H3 N2毒株。有TIV适应症的风险受试者应考虑进行皮内免疫，以补偿免疫原性降低。(c)2012爱思唯尔有限公司保留所有权利。
Background: We hypothesized that low dose intradermal vaccination of the trivalent influenza vaccine (TIV) delivered by the MicronJet600 (TM) (NanoPass Technologies, Israel) would be non-inferior to the full dose intramuscular and mid dose Intanza (R) vaccination in the elderly and the chronically ill adults.Methods: We performed a prospective randomized trial on elderly and chronically ill adults. Subjects were randomly assigned into 4 groups. Groups ID3 and ID9 received reduced dose ID TIV (3 mu g and 9 mu g of hemagglutinin (HA) per strain respectively) delivered by MicronJet600 (TM) (NanoPass Technologies, Israel). Group INT9 received reduced dose ID TIV (9 mu g) delivered by Becton Dickinson's Soluvia (TM) device (Intanza (R) 9, Sanofi-Pasteur, France). Control group IM15 received a full dose IM TIV (15 mu g). We measured antibody titers by hemagglutination inhibition (HAI) and microneutralization (MN) assays at baseline and day 21.Results: Baseline characteristics for all groups were similar (group and sample sizes: ID3 = 63; ID9 = 68; INT9 = 65; and IM15 = 66). At day 21 post vaccination, the GMT ratio and the seroconversion rates difference for all three strains of the ID vaccine groups were non-inferior to the IM vaccine group. The seroconversion rate, seroprotection rate, and the GMT of the H1N1 strains by HAI and MN assays were significantly higher in the ID groups compared with the full dose IM vaccine group. The seroconversion rates of the H3N2 strain by HAI assay were also significantly higher in the ID groups when compared with the full dose IM group. Direct comparison among the three ID groups showed no significant differences. No serious adverse events related to vaccination were reported.Conclusion: Dose-sparing ID TIV can overcome reduced immunogenicity of the H1N1 strain, and according to some measures, for the H3N2 strain. At risk subjects indicated for the TIV should be considered for intradermal immunization to compensate for reduced immunogenicity. (c) 2012 Elsevier Ltd. All rights reserved.