THE EFFICACY IN NAVAJO INFANTS OF A CONJUGATE VACCINE CONSISTING OF HAEMOPHILUS-INFLUENZAE TYPE-B POLYSACCHARIDE AND NEISSERIA-MENINGITIDIS OUTER-MEMBRANE PROTEIN COMPLEX
THE EFFICACY IN NAVAJO INFANTS OF A CONJUGATE VACCINE CONSISTING OF HAEMOPHILUS-INFLUENZAE TYPE-B POLYSACCHARIDE AND NEISSERIA-MENINGITIDIS OUTER-MEMBRANE PROTEIN COMPLEX
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DOI：
10.1056/nejm199106203242503
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发表时间：
1991-06-20
影响因子：
158.5
通讯作者：
AHONKHAI, V
中科院分区：
文献类型：
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作者：
SANTOSHAM, M;WOLFF, M;AHONKHAI, V
研究背景和方法。已经开发了几种针对b型流感嗜血杆菌的结合疫苗，以寻找一种即使在年幼婴儿中也能诱导保护的疫苗。我们评估了将b型流感嗜血杆菌荚膜多糖与B群脑膜炎奈瑟菌外膜蛋白复合体(OMPC)连接的结合疫苗的安全性和有效性。我们在纳瓦霍婴儿中进行了一项双盲、安慰剂对照试验，这些婴儿是b型流感嗜血杆菌引起系统性感染的高危人群。这些婴儿被随机分配到42-90天时接种第一剂疫苗或安慰剂，在70-146天时接种第二剂疫苗。在试验中，2588名婴儿被分配接受疫苗接种，2602名婴儿接受安慰剂治疗。疫苗组的平均随访期为269天，安慰剂组为267天。在18个月大之前，疫苗组有1例系统性b型流感嗜血杆菌感染，而安慰剂组有22例(P<；0.001；疗效点估计，95%；95%可信区间，72%至99%)。在安慰剂组的22例b型流感嗜血杆菌感染中，有13例是脑膜炎。在接受两种疫苗接种的儿童中，疫苗组(n=2056)和安慰剂组(n=2105)有1例b型流感嗜血杆菌感染(P<；0.001；疗效点估计，93%；95%可信区间，53%至98%)。疫苗组的单一感染发生在151个半月大的患有骨髓炎的婴儿。在第一次和第二次接种之间，疫苗组没有b型流感嗜血杆菌感染，而安慰剂组有8例(P<；0.005；疗效点估计，100%；95%可信区间，41%到100%)。B型流感嗜血杆菌OMPC疫苗在2个月和4个月龄时接种是安全的，对18个月以下婴儿由b型流感嗜血杆菌引起的侵袭性疾病具有很高的保护率。保护在第一剂之后就开始了。
Background and Methods. Several conjugate vaccines against Haemophilus influenzae type b have been developed in the search for one that induces protection even in young infants. We evaluated the safety and efficacy of a conjugate vaccine that links the H. influenzae type b capsular polysaccharide to the outer-membrane protein complex (OMPC) of Neisseria meningitidis serogroup B. We conducted a double-blind, placebo-controlled trial in Navajo infants, who are at high risk for systemic infections caused by H. influenzae type b. The infants were randomly assigned to receive the first dose of vaccine or placebo at 42 to 90 days of age and the second at 70 to 146 days of age.Results. Of the infants in the trial, 2588 were assigned to receive the vaccine and 2602 to receive placebo. The mean follow-up was 269 days in the vaccine group and 267 days in the placebo group. Before the age of 18 months, there was 1 systemic H. influenzae type b infection in the vaccine group, as compared with 22 in the placebo group (P < 0.001; point estimate of efficacy, 95 percent; 95 percent confidence interval, 72 to 99 percent). Of the 22 H. influenzae type b infections in the placebo group, 13 were meningitis. Among the children who received both doses, there was 1 H. influenzae type b infection in the vaccine group (n = 2056) and 14 in the placebo group (n = 2105) (P < 0.001; point estimate of efficacy, 93 percent; 95 percent confidence interval, 53 to 98 percent). The single infection in the vaccine group occurred at 151/2 months of age in an infant with osteomyelitis. Between the first and second doses there were no H. influenzae type b infections in the vaccine group and eight in the placebo group (P < 0.005; point estimate of efficacy, 100 percent; 95 percent confidence interval, 41 to 100 percent).Conclusions. The H. influenzae type b OMPC vaccine, administered at 2 and 4 months of age, is safe and induces a high rate of protection against invasive disease caused by H. influenzae type b in infants under the age of 18 months. Protection begins after the first dose.