Werzberger A, Mensch B, Kuter B, Brown L, Lewis J, Sitrin R, Miller W, Shouval D, Wiens B, Calandra G
Kiryas Joel Institute of Medicine, Monroe, N.Y. 10950.
N Engl J Med. 1992 Aug 13;327(7):453-7. doi: 10.1056/NEJM199208133270702.
Although inactivated hepatitis A vaccine is known to be well tolerated and immunogenic in healthy children and adults, its efficacy has yet to be established.
To evaluate the efficacy of the hepatitis A vaccine in protecting against clinically apparent disease, we conducted a double-blind, placebo-controlled trial in an Hasidic Jewish community in upstate New York that has had recurrent outbreaks of hepatitis A. At the beginning of a summer outbreak, 1037 healthy seronegative children 2 to 16 years of age were randomly assigned to receive one intramuscular injection of a highly purified, formalin-inactivated hepatitis A vaccine or placebo. A case was defined by the presence of typical signs and symptoms, a diagnostic increase in IgM antibody to hepatitis A, and a serum concentration of alanine aminotransferase at least twice the upper limit of normal. Cases occurring greater than or equal to 50 days after the injection were included in the evaluation of efficacy. The children were followed for a mean of 103 days.
A total of 519 children received vaccine, and 518 received placebo. The vaccine was well tolerated, with no serious adverse reactions. From day 50 after the injection, 25 cases of clinically apparent hepatitis A occurred in the placebo group and none in the vaccine group (P less than 0.001), confirming that the vaccine had 100 percent protective efficacy. Before day 21, seven cases occurred in the vaccine group and three cases in the placebo group. After that time, there were no cases among vaccine recipients and 34 cases among placebo recipients.
The inactivated purified hepatitis A vaccine that we tested is well tolerated, and a single dose is highly protective against clinically apparent hepatitis A.
尽管已知灭活甲肝疫苗在健康儿童和成人中耐受性良好且具有免疫原性，但其疗效尚未得到证实。
为评估甲肝疫苗预防临床显性疾病的疗效，我们在纽约州北部一个曾多次爆发甲肝的哈西德犹太社区进行了一项双盲、安慰剂对照试验。在夏季疫情开始时，1037名2至16岁的健康血清学阴性儿童被随机分配接受一次肌肉注射高纯度福尔马林灭活甲肝疫苗或安慰剂。病例定义为出现典型症状和体征、甲型肝炎IgM抗体诊断性升高以及血清丙氨酸转氨酶浓度至少为正常上限的两倍。注射后50天及以上发生的病例纳入疗效评估。对儿童进行了平均103天的随访。
共有519名儿童接受了疫苗，518名接受了安慰剂。疫苗耐受性良好，无严重不良反应。从注射后第50天起，安慰剂组发生了25例临床显性甲型肝炎，疫苗组无病例发生（P<0.001），证实该疫苗具有100%的保护效力。在第21天之前，疫苗组发生了7例，安慰剂组发生了3例。此后，疫苗接种者中无病例，安慰剂接种者中有34例。
我们测试的灭活纯化甲肝疫苗耐受性良好，单剂量对临床显性甲型肝炎具有高度保护作用。
