PREVENTION OF TYPHOID-FEVER IN NEPAL WITH THE VI CAPSULAR POLYSACCHARIDE OF SALMONELLA-TYPHI - A PRELIMINARY-REPORT
PREVENTION OF TYPHOID-FEVER IN NEPAL WITH THE VI CAPSULAR POLYSACCHARIDE OF SALMONELLA-TYPHI - A PRELIMINARY-REPORT
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DOI：
10.1056/nejm198710293171801
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发表时间：
1987-10-29
影响因子：
158.5
通讯作者：
ROBBINS, JB
中科院分区：
文献类型：
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作者：
ACHARYA, IL;LOWE, CU;ROBBINS, JB
我们进行了一项试点研究，随后在尼泊尔进行了一项大型临床试验，使用伤寒沙门氏菌（Vi）的荚膜多糖作为预防伤寒的疫苗。在涉及274名尼泊尔人的试点研究中，Vi疫苗没有明显的副作用;大约75%的人的血清抗体上升了四倍或更多。在临床试验中，五个村庄的居民肌肉注射Vi或作为对照的肺炎球菌疫苗，这些疫苗以编码的、随机排列的单剂量注射器分发。共有6 907名参与者，其中6 438名是目标人群（5至44岁）;每两天对每个人进行一次访问。对连续三天体温在37.8 ℃或以上的人进行了检查，并要求抽血进行培养。伤寒被诊断为血培养阳性或临床怀疑心动过缓，脾肿大，发热的基础上，血培养阴性。接种疫苗后17个月，对符合培养阳性或临床疑似伤寒标准的71例患者进行了破盲。对照组伤寒发病率为16.2/1000，而Vi组为4.1/1000（P<0.00001）。Vi在培养阳性病例中的有效性为72%，在临床疑似病例中为80%，在两组合并中为75%。这些数据提供了Vi抗体赋予针对伤寒的保护的证据。继续监测以确定Vi诱导的免疫力的持续时间。（N Engl J Med 1987; 317：1101-4.）
We conducted a pilot study followed by a large clinical trial in Nepal of the use of the capsular polysaccharide ofSalmonella typhi(Vi) as a vaccine to prevent typhoid fever. In the pilot study, involving 274 Nepalese, there were no significant side effects of the Vi vaccine; about 75 percent responded with a rise in serum antibodies of fourfold or more. In the clinical trial, residents of five villages were given intramuscular injections of either Vi or, as a control, pneumococcus vaccine dispensed in coded, randomly arranged, single-dose syringes. There were 6907 participants, of whom 6438 were members of the target population (5 to 44 years of age); each was visited every two days. Those with temperatures of 37.8°C or higher for three consecutive days were examined and asked to give blood for culture. Typhoid was diagnosed as either blood culture–positive or clinically suspected on the basis of bradycardia, splenomegaly, and fever, with a negative blood culture. Seventeen months after vaccination, the codes were broken for the 71 patients meeting the criteria for either culture-positive or clinically suspected typhoid. The attack rate of typhoid was 16.2 per 1000 among the controls and 4.1 per 1000 among those immunized with Vi (P<0.00001). The efficacy of Vi was 72 percent in the culture-positive cases, 80 percent in the clinically suspected cases, and 75 percent in the two groups combined. These data provide evidence that Vi antibodies confer protection against typhoid. Surveillance continues to determine the duration of Vi-induced immunity. (N Engl J Med 1987; 317:1101–4.)