PROTECTION AGAINST JAPANESE ENCEPHALITIS BY INACTIVATED VACCINES
PROTECTION AGAINST JAPANESE ENCEPHALITIS BY INACTIVATED VACCINES
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DOI：
10.1056/nejm198809083191004
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发表时间：
1988-09-08
影响因子：
158.5
通讯作者：
BURKE, DS
中科院分区：
文献类型：
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作者：
HOKE, CH;NISALAK, A;BURKE, DS
流行性乙型脑炎病毒引起的脑炎在亚洲每年流行一次，是世界流行性病毒性脑炎的主要原因。目前还没有任何可用的疫苗在对照试验中显示出预防这种疾病的有效性。我们在泰国北部的一个省进行了一项安慰剂对照的盲法随机试验，用两种剂量的单价(Nakayama株)或双价(Nakayama加北京株)灭活，纯化的乙型脑炎疫苗由小鼠脑内的整个病毒制成。我们检查了这些疫苗对日本脑炎和登革出血热的发病率和严重程度的影响，登革出血热是一种由密切相关的黄病毒引起的疾病。1984年11月至1985年3月，65,224名儿童接种了两剂单价乙型脑炎疫苗(n=21,628)、双价乙型脑炎疫苗(n=22,080)或破伤风类毒素安慰剂(n=21,516)，副作用很小。由乙型脑炎病毒引起的脑炎的累积发病率在安慰剂组为51/10万，在每个疫苗组为5/10万。两个疫苗组的总有效率为91%(95%的可信区间，70%至97%)。登革热出血热的发病率有所下降，但并不显著。登革热病例的严重程度也有所降低。我们的结论是，两种剂量的乙脑灭活疫苗，无论是单价还是双价，都可以预防乙型脑炎病毒引起的脑炎，对登革出血热的严重程度可能有有限的有益影响。
Encephalitis caused by Japanese encephalitis virus occurs in annual epidemics throughout Asia, making it the principal cause of epidemic viral encephalitis in the world. No currently available vaccine has demonstrated efficacy in preventing this disease in a controlled trial. We performed a placebo-controlled, blinded, randomized trial in a northern Thai province, with two doses of monovalent (Nakayama strain) or bivalent (Nakayama plus Beijing strains) inactivated, purified Japanese encephalitis vaccine made from whole virus derived from mouse brain. We examined the effect of these vaccines on the incidence and severity of Japanese encephalitis and dengue hemorrhagic fever, a disease caused by a closely related flavivirus. Between November 1984 and March 1985, 65,224 children received two doses of monovalent Japanese encephalitis vaccine (n = 21,628), bivalent Japanese encephalitis vaccine (n = 22,080), or tetanus toxoid placebo (n = 21,516), with only minor side effects. The cumulative attack rate for encephalitis due to Japanese encephalitis virus was 51 per 100,000 in the placebo group and 5 per 100,000 in each vaccine group. The efficacy in both vaccine groups combined was 91 percent (95 percent confidence interval, 70 to 97 percent). Attack rates for dengue hemorrhagic fever declined, but not significantly. The severity of cases of dengue was also reduced. We conclude that two doses of inactivated Japanese encephalitis vaccine, either monovalent or bivalent, protect against encephalitis due to Japanese encephalitis virus and may have a limited beneficial effect on the severity of dengue hemorrhagic fever.