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背景正值流感大流行,婴儿和儿童需要用安全、有效的2009A(H1N1)流感疫苗。目的评估用于儿童2009A(H1N1)流感疫苗的免疫原性和安全性。设计组合和参试者随机、观察者盲、年龄分层平行组研究,对某2009A(H1N1)流感灭活、裂解病毒疫苗用于生活在澳大利亚,年龄在6个月至9岁以下,370名健康婴儿和儿童的2个剂量进行了评估。干预将单价血凝素抗原非佐剂2009A(H1N1)流感疫苗15μg或30μg分2次肌内注射,中间相隔21d。主要结果测量血凝抑制剂试验评价参试者抗体滴度比≥1:40,血清转换、抗体滴度显著增加,几何平均滴度增加。对每次接种后7d内或21d发生的负性事件做了评估。结果接种首次剂量疫苗后,抗体滴度达≥1:40包括:15μg组,174例婴儿和儿童中的161例[92.5%,95%CI(87.6%,95.6%)];30μg组,172例婴儿和儿童中的168例[97.7%,95%CI(94.2%,99.1%)],相应的血清转换率为86.8%[95%CI(80.9%,91.0%)]和94.2%[95%CI(89.6%,96.8%)],几何平均滴度增加13.6[95%CI(11.8,15.6)]和18.3[95%CI(15.7,21.4)]。所有的参试者在第二次接种后,呈现抗体滴度均≥1:40。免疫反应强烈,无论年龄、基线血清状况或季节流感接种情况如何。结论疫苗的15μg单剂量为可致年龄始于6个月的婴儿和儿童产生免疫性,与疫苗相关的反应严重度呈轻至中度。
Against the background of the flu pandemic, babies and children need a safe and effective 2009A (H1N1) flu vaccine. Objective To evaluate the immunogenicity and safety of the 2009A (H1N1) influenza vaccine for children. Design mix and randomization of participants, observer blind, age-stratified parallel group study of a 2009A (H1N1) flu inactivated, split virus vaccine for living in Australia, aged 6 months to under 9 years, 370 Two doses of healthy infants and children were evaluated. Interventions Monovalent hemagglutinin antigen unadjuvanted 2009A (H1N1) influenza vaccine 15μg or 30μg intramuscularly divided into 2 times, the middle interval 21d. MAIN RESULTS Measurement of hemagglutinin inhibitor test The antibody titers of participants ≥ 1: 40, seroconversion, antibody titers increased significantly, and geometric mean titers increased. Negative events occurring within 7 days or 21 days after each inoculation were evaluated. RESULTS: After the first dose of vaccine was inoculated, the antibody titers ≥1: 40 included 161 of the 15 μg, 174 infants and children [92.5%, 95% CI (87.6%, 95.6% The corresponding seroconversion rates were 86.8% [95% CI (80.9%, 91.0%]] and 94.2% [95% CI (97.9% (89.6%, 96.8%)], geometric mean titers increased by 13.6 [95% CI (11.8,15.6)] and 18.3 [95% CI (15.7,21.4)]. All participants showed antibody titers ≥1: 40 after the second vaccination. The immune response is strong, regardless of age, baseline serum status or seasonal flu inoculation. Conclusions A single 15 μg dose of the vaccine is immunogenic in infants and children 6 months of age and the severity of the vaccine-related reaction is mild to moderate.