PROTECTIVE EFFECT OF WC3 VACCINE AGAINST ROTAVIRUS DIARRHEA IN INFANTS DURING A PREDOMINANTLY SEROTYPE-1 ROTAVIRUS SEASON

PROTECTIVE EFFECT OF WC3 VACCINE AGAINST ROTAVIRUS DIARRHEA IN INFANTS DURING A PREDOMINANTLY SEROTYPE-1 ROTAVIRUS SEASON
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DOI:
10.1093/infdis/158.3.570
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发表时间:
1988-09-01
影响因子:
6.4
通讯作者:
PLOTKIN, SA
PLOTKIN, SA
中科院分区:
医学2区
文献类型:
--
作者:
CLARK, HF;BORIA, FE;PLOTKIN, SA

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我们使用双盲、安慰剂对照试验研究了轮状病毒季节前接种WC3轮状病毒疫苗对104名婴儿(年龄3-12个月)的疗效。49名婴儿接受了疫苗接种;55名婴儿接受了安慰剂。轮状病毒病在这个季节主要由一种1型血清毒株引起。在安慰剂接受者中,有14例轮状病毒腹泻(发病率,25%);11例中到重度(发病率,20%)。疫苗接种者只经历了3例轮状病毒病(发病率为6.1%),均为轻度。当评估了所有临床显著腹泻(CSD)病例(无论是否与轮状病毒相关)时,WC3疫苗对CSD的总发作数提供了统计学上显著的保护(P<.01),并减少了与CSD相关的腹泻、呕吐、发热或疾病的天数。接种WCS疫苗的婴儿中有71%对疫苗有血清抗体反应。在经历自然疾病的14名安慰剂接受者中,主要对1型血清有抗体反应。轮状病毒季节结束后采集的血清显示,接种疫苗组和安慰剂组的自然轮状病毒感染率几乎相同(40%)。
We used a double-blind, placebo-controlled trial to study the efficacy of WC3 rotavirus vaccine administered to 104 infants (ages, three to 12 months) before the rotavirus season. Forty-nine infants received vaccine; 55 received placebo. Rotavirus disease during this season was predominantly caused by a serotype 1 strain. In placebo recipients there were 14 cases of rotavirus diarrhea (attack rate, 25%); 11 were moderate to severe (attack rate, 20%). Vaccinies experienced only three cases of rotavirus disease (attack rate, 6.1%), all mild. When all cases (whether associated with rotavirus or not) of clinically significant diarrhea (CSD) were evaluated, WC3 vaccine provided statistically significant (P < .01) protection against the total number of episodes of CSD and reduced the number of days of CSD-associated diarrhea, vomiting, fever, or illness. Seventy-one percent of the WCs-vaccinated infants had serum antibody responses to the vaccine. The 14 placebo recipients who experienced natural disease predominantly had antibody responses to serotype 1. Sera taken after the rotavirus season revealed a nearly identical rate (40%) of natural rotavirus infection in the vaccinated and placebo groups.