Immunogenicity of a Monovalent 2009 Influenza A(H1N1) Vaccine in Infants and Children A Randomized Trial
Immunogenicity of a Monovalent 2009 Influenza A(H1N1) Vaccine in Infants and Children A Randomized Trial
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DOI：
10.1001/jama.2009.1911
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发表时间：
2010-01-06
影响因子：
120.7
通讯作者：
Greenberg, Michael
中科院分区：
文献类型：
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作者：
Nolan, Terry;McVernon, Jodie;Greenberg, Michael
在持续的流感大流行中，需要为婴儿和儿童提供一种安全有效的2009年甲型H1N1流感疫苗。目的评价2009年甲型H1N1流感疫苗在儿童中的免疫原性和安全性。设计、环境和参与者：一项随机、观察者盲、年龄分层、平行组研究，对生活在澳大利亚的370名6个月至9岁以下的健康婴儿和儿童接种两剂2009年甲型H1N1流感病毒灭活疫苗进行了评估。干预措施：肌肉注射单价、无佐剂2009年甲型H1N1流感疫苗15 μ g或30 μ g血凝素抗原剂量，两剂方案，间隔21天。主要结果测量血球凝集抑制试验用于估计抗体滴度为1:40或更高的参与者比例，血清转换，或显著的抗体滴度增加，以及几何平均滴度因子增加。评估每次疫苗接种后7天内征求的不良事件和21天内非征求的不良事件。结果首次接种疫苗后，15 μ g组174例婴儿和儿童中有161例（92.5%，95%可信区间[CI]， 87.6% ~ 95.6%）的抗体滴度为1:40或更高，30 μ g组172例婴儿和儿童中有168例（97.7%，95%可信区间[CI]， 94.2% ~ 99.1%）。相应的血清转化率分别为86.8%（95% CI, 80.9%-91.0%）和94.2% (95% CI, 89.6%-96.8%)，几何平均滴度因子增加分别为13.6 （95% CI, 11.8-15.6）和18.3 （95% CI, 15.7-21.4）。所有参与者在接种第二剂疫苗后抗体滴度均为1:40或更高。无论年龄、基线血清状态或季节性流感疫苗接种状况如何，免疫反应都很强劲。大多数不良事件的严重程度为轻至中度。结论1剂15 μ g疫苗对6月龄婴幼儿具有免疫原性，疫苗相关反应的严重程度为轻中度。试验注册clinicaltrials.gov识别码：NCT00940108 JAMA。2010年;303 (1): 37-46
Context In the ongoing influenza pandemic, a safe and effective vaccine against 2009 influenza A(H1N1) is needed for infants and children.Objective To assess the immunogenicity and safety of a 2009 influenza A(H1N1) vaccine in children.Design, Setting, and Participants Randomized, observer-blind, age-stratified, parallel group study assessing 2 doses of an inactivated, split-virus 2009 influenza A(H1N1) vaccine in 370 healthy infants and children aged 6 months to less than 9 years living in Australia.Intervention Intramuscular injection of 15 mu g or 30 mu g of hemagglutinin antigen dose of monovalent, unadjuvanted 2009 influenza A(H1N1) vaccine in a 2-dose regimen, administered 21 days apart.Main Outcome Measures Hemagglutination inhibition assay to estimate the proportion of participants with antibody titers of 1:40 or greater, seroconversion, or a significant antibody titer increase, and factor increase in geometric mean titer. Assessments of solicited adverse events during 7 days and unsolicited adverse events for 21 days after each vaccination.Results Following the first dose of vaccine, antibody titers of 1: 40 or greater were observed in 161 of 174 infants and children in the 15-mu g group (92.5%; 95% confidence interval [CI], 87.6%-95.6%) and in 168 of 172 infants and children in the 30-mu g group (97.7%; 95% CI, 94.2%-99.1%). Corresponding seroconversion rates were 86.8%(95% CI, 80.9%-91.0%) and 94.2% (95% CI, 89.6%-96.8%), and factor increases in geometric mean titer were 13.6 (95% CI, 11.8-15.6) and 18.3 (95% CI, 15.7-21.4). All participants demonstrated antibody titers of 1: 40 or greater after the second vaccine dose. Immune responses were robust regardless of age, baseline serostatus, or seasonal influenza vaccination status. The majority of adverse events were mild to moderate in severity.Conclusion One 15-mu g dose of vaccine was immunogenic in infants and children starting at 6 months of age and vaccine-associated reactions were mild to moderate in severity.Trial Registration clinicaltrials.gov Identifier: NCT00940108 JAMA. 2010; 303(1): 37-46