A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine
A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine
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DOI：
10.1056/nejm199602083340602
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发表时间：
1996-02-08
影响因子：
158.5
通讯作者：
Storsaeter, J
中科院分区：
文献类型：
--
作者：
Gustafsson, L;Hallander, HO;Storsaeter, J
背景由于对安全性和有效性的关注，自1979年以来，瑞典的疫苗接种计划中没有包括百日咳疫苗。为了提供可能允许重新引入百日咳疫苗的数据，我们对两种无细胞百日咳疫苗和一种全细胞百日咳疫苗进行了安慰剂对照试验。在获得知情同意后，9829名1992年出生的儿童被随机分配接受四种疫苗之一：双组分无细胞白喉-破伤风-百日咳（DTP）疫苗（2566名儿童），一种五组分无细胞百白破疫苗（2587名儿童），在美国获得许可的全细胞百白破疫苗（2102名儿童），或（作为对照）单独接种含有白喉和破伤风类毒素（DT）的疫苗（2574名儿童）。在2个月、4个月和6个月大时接种疫苗，然后对儿童的百日咳体征进行额外2年的随访（平均年龄为2岁半）。与其他三种疫苗相比，全细胞疫苗与延长性哭泣、发绀、发热和局部反应的发生率显著较高相关。无细胞疫苗和对照DT疫苗的不良事件发生率相似。三剂疫苗后，对于实验室确诊的百日咳病例或与阵发性咳嗽大于或等于21天的受感染家庭成员接触的百日咳，双组分疫苗的有效性为58.9（95%置信区间，50.9%至65.9%），五组分疫苗为85.2%（95%置信区间，80.6%至88.8%），全细胞疫苗为48.3%（95%置信区间，37.0%至57.6%）。我们评估的五组分无细胞百日咳疫苗可推荐用于一般用途，因为它具有良好的安全性，并可持续预防百日咳。双组分无细胞疫苗和全细胞疫苗的有效性较低。
Background. Because of concern about safety and efficacy, no pertussis vaccine has been included in the vaccination program in Sweden since 1979, To provide data that might permit the reintroduction of a pertussis vaccine, we conducted a placebo-controlled trial of two acellular and one whole-cell pertussis vaccines.Methods. After informed consent was obtained, 9829 children born in 1992 were randomly assigned to receive one of four vaccines: a two-component acellular diphtheria-tetanus-pertussis (DTP) vaccine (2566 children), a five-component acellular DTP vaccine (2587 children), a whole-cell DTP vaccine licensed in the United States (2102 children), or (as a control) a vaccine containing diphtheria and tetanus toxoids (DT) alone (2574 children). The vaccines were given at 2, 4, and 6 months of age, and the children were then followed for signs of pertussis for an additional 2 years (to a mean age of 2 1/2 years).Results. The whole-cell vaccine was associated with significantly higher rates of protracted crying, cyanosis, fever, and local reactions than the other three vaccines. The rates of adverse events were similar for the acellular vaccines and the control DT vaccine. After three doses, the efficacy of the vaccines with respect to pertussis linked to a laboratory-confirmed case of pertussis or contact with an infected household member with paroxysmal cough for greater than or equal to 21 days was 58.9 percent for the two-component vaccine (95 percent confidence interval, 50.9 to 65.9 percent), 85.2 percent for the five-component vaccine (95 percent confidence interval, 80.6 to 88.8 percent), and 48.3 percent for the whole-cell vaccine (95 percent confidence interval, 37.0 to 57.6 percent).Conclusions. The five-component acellular pertussis vaccine we evaluated can be recommended for general use, since it has a favorable safety profile and confers sustained protection against pertussis. The two-component acellular vaccine and the whole-cell vaccine were less efficacious.