Riedemann S, Reinhardt G, Frösner G G, Ibarra H, Moraleda L, Hering V, Siegel F, Toledo C, Leon J, Gonzalez J L
Institute of Microbiology, Universidad Austral de Chile, Valdivia.
Vaccine. 1992;10 Suppl 1:S152-5. doi: 10.1016/0264-410x(92)90573-3.
A placebo-controlled, double-blind study on the efficacy of a hepatitis A vaccine (SmithKline Beecham Biologicals) was started in a region of Chile in September 1990, using hepatitis B vaccine as control. A total of 260 healthy children, 6-15 years of age, negative for antibody to hepatitis A virus (anti-HAV), antibody to HAV immunoglobulin M (IgM), hepatitis B surface antigen, and antibody to hepatitis B surface and core antigens by ELISA tests within 7 days before vaccination, were randomly assigned to two study groups: 128 children received the vaccine with a yellow label (group 1), and 132 children the vaccine with an orange label (group 2) at months 0, 1 and 6. Blood for serology and transaminase determination was drawn at months 1, 2, 6, 7 and 12. Both vaccines were tolerated equally well and no serious side effects were seen. In group 1 (presumed hepatitis A vaccine group), anti-HAV was detected (20% inhibition was used as the cut-off level) in 122 of 128 children (95.5%) tested at month 1, in 126 of 127 (99.2%) at month 2, in 126 of 127 (99.2%) at month 6 and in 126 of 126 (100%) at month 7. One anti-HAV seroconversion seen at month 1 was associated with presence of anti-HAV IgM and therefore probably represents HAV infection. Geometric mean anti-HAV concentration of the other children was 128, 342, 214 and 2301 mIU/ml at months 1, 2, 6 and 7, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)
1990年9月，在智利的一个地区开展了一项关于甲型肝炎疫苗（史克必成生物制品公司生产）疗效的安慰剂对照双盲研究，使用乙型肝炎疫苗作为对照。共有260名6至15岁的健康儿童，在接种疫苗前7天内通过ELISA检测甲型肝炎病毒抗体（抗-HAV）、抗-HAV免疫球蛋白M（IgM）、乙型肝炎表面抗原以及乙型肝炎表面和核心抗原抗体均为阴性，这些儿童被随机分为两个研究组：128名儿童在第0、1和6个月接种黄色标签疫苗（第1组），132名儿童接种橙色标签疫苗（第2组）。在第1、2、6、7和12个月采集血液进行血清学和转氨酶测定。两种疫苗的耐受性相当，未观察到严重副作用。在第1组（假定为甲型肝炎疫苗组），在第1个月检测的128名儿童中有122名（95.5%）检测到抗-HAV（以20%抑制率作为临界值），在第2个月127名中有126名（99.2%），在第6个月127名中有126名（99.2%），在第7个月126名中有126名（100%）。在第1个月观察到的1例抗-HAV血清转化与抗-HAV IgM的存在有关，因此可能代表甲型肝炎病毒感染。其他儿童在第1、2、6和7个月的抗-HAV几何平均浓度分别为128、342、214和2301 mIU/ml。（摘要截选至250字）
