Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
Vaccine. 2011 Feb 4;29(7):1395-8. doi: 10.1016/j.vaccine.2010.12.050. Epub 2011 Jan 1.
The 2009 influenza pandemic was caused by a novel triple-reassortant influenza A/H1N1 virus that was further recombined with a Eurasian pig flu virus. Vaccination is a key countermeasure for disease; however, little data assessing vaccine effectiveness (VE) against the pandemic H1N1 virus are available. We conducted a matched case-control study to assess effectiveness of the 2009 influenza A/H1N1 monovalent vaccine against laboratory-confirmed, medically attended influenza patients. Subjects included in the study were ≥ 10 years of age and were treated at five university hospitals in the Republic of Korea (ROK) from December 2009 through March 2010. For subjects visiting outpatient clinics with influenza-like illness (ILI), real time reverse transcription polymerase chain reaction (rRT-PCR) was used to diagnose 2009 H1N1 influenza virus infection. Subjects with positive rRT-PCR were classified as cases, while those testing negative were controls. A valid vaccination corresponded to ≥ 14 days between receiving a dose of vaccine and symptom onset. Overall, 416 ILI subjects were analyzed, and 60 (14.4%) were vaccinated with the 2009 influenza A/H1N1 monovalent vaccine. The overall VE against pandemic 2009 A/H1N1 virus illness after adjustment for age group and presence of chronic medical conditions was 73.4% (95% confidence interval [CI]=49.1-86.1%). Both vaccine formulations (unadjuvanted and MF-59 adjuvanted) showed a statistically significant VE. In conclusion, the 2009 influenza A/H1N1 monovalent vaccine was substantially protective against pandemic influenza in the ROK during the 2009-2010 season.
2009 年流感大流行是由一种新型的三重重配甲型 H1N1 流感病毒引起的，该病毒进一步与欧亚猪流感病毒重组。疫苗接种是疾病的关键对策；然而，评估针对大流行 H1N1 病毒的疫苗有效性（VE）的数据很少。我们进行了一项匹配病例对照研究，以评估 2009 年甲型 H1N1 单价疫苗对实验室确诊的、需要医学治疗的流感患者的有效性。该研究纳入的受试者年龄≥10 岁，并于 2009 年 12 月至 2010 年 3 月在韩国（ROK）的五所大学医院接受治疗。对于在门诊就诊有流感样疾病（ILI）的受试者，实时逆转录聚合酶链反应（rRT-PCR）用于诊断 2009 年 H1N1 流感病毒感染。rRT-PCR 检测呈阳性的受试者被归类为病例，而检测呈阴性的受试者则为对照。有效的疫苗接种对应于接种一剂疫苗后至症状出现之间≥14 天。总体而言，分析了 416 例 ILI 受试者，其中 60 例（14.4%）接种了 2009 年甲型 H1N1 单价疫苗。在调整年龄组和慢性疾病存在情况后，对大流行 2009 年 A/H1N1 病毒病的总体 VE 为 73.4%（95%置信区间[CI]=49.1-86.1%）。两种疫苗配方（无佐剂和 MF-59 佐剂）均显示出统计学显著的 VE。总之，在 2009-2010 年季节，2009 年甲型 H1N1 单价疫苗在韩国对大流行流感具有实质性保护作用。
