Takahashi Hiroaki, Yano Takuya, Fukuta Miwa, Yamauchi Akinori, Okuma Kazuyuki, Ihara Toshiaki, Nakano Takashi, Matsuda Tadashi, Torigoe Sadayoshi, Nii Ritsue, Isaji Machiko, Watanabe Masahiro, Ochiai Hitoshi, Sakatoku Hiroyuki, Kato Takashi, Maeda Kazuhiro, Okuno Yoshinobu, Kamiya Hitoshi
Mie Prefecture Health and Environment Research Institute.
Kansenshogaku Zasshi. 2013 Mar;87(2):195-206. doi: 10.11150/kansenshogakuzasshi.87.195.
We examined the efficacy and safety of inactivated influenza vaccine when the amount of HA influenza vaccination in children was increased to the dose recommended by the WHO. The purpose of this study was to obtain basic evidence to review the vaccination dose in Japanese children. HA influenza vaccine produced by the Research Foundation for Microbial Diseases of Osaka University (Biken) licenced in Japan was administered through vaccination at the international dose, and split HA influenza vaccine produced by Sanofi Pasteur corp. (Sanofi) was used as control. Children from 6 months to less than 13 years of age were registered, and vaccinated with doses of 0.25 mL or 0.5 mL. Clinical symptoms during the influenza season were monitored to investigate vaccine efficacy, and information on adverse reactions was collected to evaluate safety profile. Paired serum HI and NT antibody titers were measured at pre first dose and post second dose of vaccination. Both HI and NT antibody titers for H1N1 subtype were satisfactory elevated after administration of both vaccines. Elevation of the NT antibody titer for the H3N2 subtype was observed for both vaccines, but the H3N2 HI antibody titer for the Biken vaccine was not so high. For the subtype B virus, the NT titer had a better response than the HI titer for both vaccines. As only the H1N1 virus was prevalent in the area during the study period, we performed factor analysis concerning influenza contraction only for the H1N1 antibody titer. An HI titer of 1 : 40 or more at post-vaccination was a significant factor to lower the risk of influenza contraction. The relative risk for fever among children with an HI titer of 1 : 20 or less was significantly higher than those with an HI titer of 1 : 40 or more. Children with a higher HI titer had better prevention against fever, so that both vaccines were considered to be effective. As for the appearance of adverse reactions, both vaccines were considered to be safe. From the above-mentioned results, vaccination with the Japanese Biken vaccine at an international dose was thought to be an effective and safe procedure.
我们研究了将儿童流感疫苗血凝素（HA）接种量增加至世界卫生组织推荐剂量时，灭活流感疫苗的疗效和安全性。本研究的目的是获取基础证据，以重新审视日本儿童的疫苗接种剂量。使用在日本获得许可的大阪大学微生物病研究所（Biken）生产的HA流感疫苗，按照国际剂量进行接种，并将赛诺菲巴斯德公司（Sanofi）生产的裂解HA流感疫苗用作对照。登记了6个月至未满13岁的儿童，接种剂量为0.25 mL或0.5 mL。在流感季节监测临床症状以调查疫苗疗效，并收集不良反应信息以评估安全性。在首次接种前和第二次接种后测量配对血清的血凝抑制（HI）和神经氨酸酶抑制（NT）抗体滴度。两种疫苗接种后，H1N1亚型的HI和NT抗体滴度均得到满意的升高。两种疫苗均观察到H3N2亚型的NT抗体滴度升高，但Biken疫苗的H3N2 HI抗体滴度不高。对于B型病毒，两种疫苗的NT滴度反应均优于HI滴度。由于研究期间该地区仅H1N1病毒流行，我们仅针对H1N1抗体滴度进行了流感感染因素分析。接种后HI滴度为1:40或更高是降低流感感染风险的重要因素。HI滴度为1:20或更低的儿童发热的相对风险显著高于HI滴度为1:40或更高的儿童。HI滴度较高的儿童对发热有更好的预防作用，因此两种疫苗均被认为有效。至于不良反应的出现，两种疫苗均被认为是安全的。根据上述结果，按国际剂量接种日本Biken疫苗被认为是一种有效且安全的程序。
