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健康婴儿口服89-12株人轮状病毒活疫苗的第二年随访评估。

Second-year follow-up evaluation of live, attenuated human rotavirus vaccine 89-12 in healthy infants.

作者信息

Bernstein David I, Sack David A, Reisinger Keith, Rothstein Edward, Ward Richard L

机构信息

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, USA.

出版信息

J Infect Dis. 2002 Nov 15;186(10):1487-9. doi: 10.1086/344732. Epub 2002 Oct 22.

DOI:10.1086/344732
PMID:12404166
Abstract

Rotavirus vaccine development is a high priority. The association between the tetravalent rhesus-human reassortant rotavirus vaccine and intussusception has increased the need to develop new vaccines. In a small efficacy trial, the human rotavirus vaccine 89-12 recently has been shown to be safe and effective; 184 of the 215 healthy infants initially enrolled in this trial were followed for a second year. Vaccine efficacy during the second year was 59% (P=.047). For the 2 years of observation, vaccine efficacy was 76% against rotavirus gastroenteritis, 83% against severe rotavirus gastroenteritis, and 100% against rotavirus illnesses requiring medical intervention (P<.001 for each). These encouraging results have led to continued evaluation, in several countries, of a vaccine candidate derived from strain 89-12.

摘要

轮状病毒疫苗的研发是重中之重。四价恒河猴-人重配轮状病毒疫苗与肠套叠之间的关联增加了研发新疫苗的必要性。在一项小型疗效试验中,人轮状病毒疫苗89-12最近已被证明安全有效;最初参与该试验的215名健康婴儿中有184名接受了第二年的随访。第二年的疫苗效力为59%(P = 0.047)。在两年的观察期内,疫苗对轮状病毒肠胃炎的效力为76%,对严重轮状病毒肠胃炎的效力为83%,对需要医疗干预的轮状病毒疾病的效力为100%(每项P<0.001)。这些令人鼓舞的结果促使多个国家对源自89-12毒株的候选疫苗继续进行评估。

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