Hepatitis A virus (HAV) infection is of public health significance among infants and diapered children. Although two licensed HAV vaccines are available, they have not been assessed widely in children under the age of 2 years and are not currently licensed for this age group. The purpose of this study was to evaluate the immunogenicity and reactogenicity of HAV vaccine in seronegative infants. Fifty-three healthy infants were immunized with 360 ELISA Units (EL.U.) of an inactivated HAV vaccine at 2, 4, and 6 (Group 1) or 2, 4, and 15 months of age (Group 2). These injections were not received on the same day that participants received their routine childhood immunizations. HAV serum antibodies were detected using a modified radioimmunoassay procedure and concentrations were calculated using a World Health Organization serum anti-HAV reference standard. No serious-systemic or local reactions were noted among the immunized infants. Three months following the third immunization, seroconversion rates were 100% and 93% in groups 1 and 2, respectively. No significant differences were observed in the geometric mean anti-HAV concentrations between the two groups at comparable time points, i.e. 2 months after the second dose, 3 months after the third dose, and 19 months after the first dose. Three infants, not included in the data presented above, had preexisting maternal antibodies; one never responded to the vaccine and the other two did not respond until maternal antibody levels had become reduced. The results indicate that the inactivated HAV vaccine is highly immunogenic in seronegative infants and could be included in the routine harmonized infant immunization schedule.

译文

甲型肝炎病毒(HAV)感染在婴儿和尿布儿童中具有公共卫生意义。尽管有两种许可的HAV疫苗可供使用,但尚未对2岁以下的儿童进行广泛的评估,并且目前尚未获得该年龄组的许可。这项研究的目的是评估血清阴性婴儿中HAV疫苗的免疫原性和反应原性。用灭活的HAV疫苗的360 ELISA单位(EL.U.)对53例健康婴儿进行免疫,分别于2、4和6岁(第1组)或2、4和15个月大(第2组)进行。在参加儿童常规免疫接种的同一天没有收到这些注射液。使用改良的放射免疫分析方法检测HAV血清抗体,并使用世界卫生组织血清抗HAV参考标准计算浓度。免疫婴儿中未发现严重的全身或局部反应。第三次免疫后三个月,第1组和第2组的血清转化率分别为100%和93%。在可比较的时间点,即第二次给药后2个月,第三次给药后3个月和第一次给药后19个月,两组之间抗HAV的几何平均浓度没有观察到显着差异。上述数据中未包括的三名婴儿已存在母体抗体。一个从未对疫苗产生反应,而另外两个直到母体抗体水平降低后才产生反应。结果表明,灭活的HAV疫苗在血清阴性婴儿中具有很高的免疫原性,可以纳入常规的统一婴儿免疫程序。

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