CAJ | 학술논문

目的：了解水痘疫苗2剂不同间隔时间免疫程序的安全性及免疫原性。方法按照随机、双盲的原则，选择符合条件的1～3岁、4～6岁、7～12岁儿童各200名，每个年龄组按照2剂间隔3个月和6个月的免疫程序，分别接种2剂冻干水痘减毒活疫苗。观察各组接种后的不良反应率，用膜抗原荧光抗体法（ FAMA）检测疫苗接种前、后血清抗体阳转率、GMT水平和平均增长倍数。结果接种2剂水痘疫苗后，总体不良反应率在4％～13％；同年龄组不同间隔时间接种2剂疫苗后，不良反应发生率差异无统计学意义；不同年龄组间不良反应发生率差异无统计学意义。同年龄组不同间隔时间免前及接种2剂后，血清GMT水平差异均无统计学意义；同年龄组接种1剂与2剂水痘疫苗的血清GMT水平，两者间差异有显著性统计学意义。接种2剂水痘疫苗的GMT增长倍数高于接种1剂。不同间隔时间接种第2剂水痘疫苗后抗体阳转率差异无统计学意义；同年龄组接种2剂后抗体阳转率高于接种1剂，两者差异有统计学意义。结论间隔3个月和6个月接种第2剂水痘疫苗，在安全性及免后GMT水平、增长倍数及抗体阳转率等4个方面，两者差异均无统计学意义。
목적：료해수두역묘2제불동간격시간면역정서적안전성급면역원성。방법안조수궤、쌍맹적원칙，선택부합조건적1～3세、4～6세、7～12세인동각200명，매개년령조안조2제간격3개월화6개월적면역정서，분별접충2제동간수두감독활역묘。관찰각조접충후적불량반응솔，용막항원형광항체법（ FAMA）검측역묘접충전、후혈청항체양전솔、GMT수평화평균증장배수。결과접충2제수두역묘후，총체불량반응솔재4％～13％；동년령조불동간격시간접충2제역묘후，불량반응발생솔차이무통계학의의；불동년령조간불량반응발생솔차이무통계학의의。동년령조불동간격시간면전급접충2제후，혈청GMT수평차이균무통계학의의；동년령조접충1제여2제수두역묘적혈청GMT수평，량자간차이유현저성통계학의의。접충2제수두역묘적GMT증장배수고우접충1제。불동간격시간접충제2제수두역묘후항체양전솔차이무통계학의의；동년령조접충2제후항체양전솔고우접충1제，량자차이유통계학의의。결론간격3개월화6개월접충제2제수두역묘，재안전성급면후GMT수평、증장배수급항체양전솔등4개방면，량자차이균무통계학의의。
Objective To observe the safety and immunological effect with a vaccination program by two doses varicella vaccine (live),freeze dryed and two different intervals.Methods According to a randomized, double-blind principle, select 200 children in each of qualified 1-3 years, 4-6 years, and 7-12 years age group, based on the immunization program with two intervals for three months and six months,separately, the subjects were inoculated with two doses of varicella vac-cine(live)freeze-dried.Adverse reaction rates were observed in each group after vaccination .The serum antibody conver-sion rate, the level of GMT and average fold of antibody increased were detected by using a membrane antigen fluorescence antibody method ( FAMA) with deffrent intervals before and after vaccination .Rseults After vaccinated two doses of the vaccine, the overall rate of adverse reaction was in 4% to 13%; the incidence of adverse reaction was no statistically significant difference between two intervals in the same age group and in different age groups too.There were no statistically significant difference in the level of serum GMT between different intervals for same age groups, and there were statistically significant difference in the level of serum GMT after vaccination in the same age groups with one dose or two doses of the vaccine.The folds about antibody increased by two doses were higher than by one dose of the vaccine in the same age group.There were no statistical difference in sero-conversion rate between two different intervals.The sero-conversion rate by two doses was higher than by one dose of the vaccine, with a statistical difference in the same age groups. Conclusion There were no statistical difference in safety, the level of serum GMT, the folds about antibody increased and sero-conversion rate with the two different intervals by the vaccine.