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对韩国目前使用的麻疹、腮腺炎和风疹联合疫苗的重新评估。

Reappraisal of MMR vaccines currently used in Korea.

作者信息

Lee Hyunju, Kim Han Wool, Cho Hye Kyung, Park Eun Ae, Choi Kyong Min, Kim Kyung-Hyo

机构信息

Department of Pediatrics, Ewha Womans University School of Medicine, Seoul, Korea.

出版信息

Pediatr Int. 2011 Jun;53(3):374-80. doi: 10.1111/j.1442-200X.2010.03244.x.

Abstract

BACKGROUND

Although MMR vaccine is widely used in Korea, there are limited studies on the currently used vaccines. We evaluated the immunogenicity and safety of MMR vaccines in Korean children.

METHODS

For first and second dose immunization, children aged 12-23 months and 4-6 years were enrolled. All subjects received a single dose of either Priorix™ (Glaxo Smithkline Biologicals, Rixensart, Belgium) or MMRII® (Merck & Co., Inc., West Point, PA, USA). Pre- and postvaccine sera were collected from all participants. Antibody levels were determined by ELISA (Enzygnost®; Dade Behring, Schwalbach, Germany). Safety monitoring included local adverse events for 5 days and systemic adverse events for 42 days following vaccination.

RESULTS

One hundred twenty-one subjects were enrolled in the 12-23 months age group and 39 in the 4-6 years age group. The seroconversion rate in the 12-23 months age group was 97.9-100.0% for measles, 85.1-88.9% for mumps and 100.0% for rubella. All children 4-6 years of age previously seronegative showed seroconversion for measles, mumps and rubella. Local adverse events were reported in 8.3-16.1% (12-23 months age) and 27.8-31.6% (4-6 years age), and 40.0-48.2% (12-23 months age) and 42.1-61.1% (4-6 years age) experienced at least more than 1 systemic adverse reaction. No vaccine-related serious adverse events were reported. Among the same age groups, there was no significant difference in adverse events between the two vaccines.

CONCLUSION

The MMR vaccines are safe and show good immunogenic responses in children. These data will be invaluable when we introduce diverse vaccines in the following future.

摘要

背景

尽管MMR疫苗在韩国广泛使用,但关于目前使用的疫苗的研究有限。我们评估了MMR疫苗在韩国儿童中的免疫原性和安全性。

方法

对于首剂和第二剂免疫接种,纳入了12至23个月大以及4至6岁的儿童。所有受试者均接种了单剂Priorix™(葛兰素史克生物制品公司,比利时里克森萨特)或MMRII®(默克公司,美国宾夕法尼亚州西点)。从所有参与者中采集疫苗接种前和接种后的血清。通过酶联免疫吸附测定法(Enzygnost®;德国达德贝林公司,施瓦尔巴赫)测定抗体水平。安全性监测包括接种疫苗后5天的局部不良事件和42天的全身不良事件。

结果

12至23个月年龄组纳入了121名受试者,4至6岁年龄组纳入了39名受试者。12至23个月年龄组中麻疹的血清转化率为97.9 - 100.0%,腮腺炎为85.1 - 88.9%,风疹为100.0%。所有先前血清学阴性的4至6岁儿童麻疹、腮腺炎和风疹均出现血清转化。局部不良事件报告发生率在12至23个月年龄组为8.3 - 16.1%,4至6岁年龄组为27.8 - 31.6%;40.0 - 48.2%(12至23个月年龄组)和42.1 - 61.1%(4至6岁年龄组)经历了至少1次以上全身不良反应。未报告与疫苗相关的严重不良事件。在同一年龄组中,两种疫苗之间的不良事件无显著差异。

结论

MMR疫苗在儿童中安全且显示出良好的免疫原性反应。这些数据在我们未来引入多种疫苗时将非常宝贵。

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