一项关于双组分无细胞、五组分无细胞和全细胞百日咳疫苗的对照试验。

A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine.

作者信息

Gustafsson L, Hallander H O, Olin P, Reizenstein E, Storsaeter J

机构信息

Sachs' Children's Hospital, Stockholm, Sweden.

出版信息

N Engl J Med. 1996 Feb 8;334(6):349-55. doi: 10.1056/NEJM199602083340602.

DOI:10.1056/NEJM199602083340602

PMID:8538705

Abstract

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 21/2 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 > or = 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.

摘要

背景

出于对安全性和有效性的担忧，自1979年以来瑞典的疫苗接种计划中未包含百日咳疫苗。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。

方法

在获得知情同意后，将1992年出生的9829名儿童随机分配接受四种疫苗之一：一种双组分无细胞白喉-破伤风-百日咳（DTP）疫苗（2566名儿童）、一种五组分无细胞DTP疫苗（2587名儿童）、一种在美国获得许可的全细胞DTP疫苗（2102名儿童），或（作为对照）仅含白喉和破伤风类毒素的疫苗（DT）（2574名儿童）。这些疫苗在2、4和6月龄时接种，然后对儿童随访另外2年（至平均年龄2.5岁）以观察百日咳迹象。

结果

全细胞疫苗与持续性哭闹、发绀、发热和局部反应的发生率显著高于其他三种疫苗。无细胞疫苗和对照DT疫苗的不良事件发生率相似。接种三剂后，对于与实验室确诊的百日咳病例相关或与患有阵发性咳嗽≥21天的感染家庭成员接触导致的百日咳，双组分疫苗的效力为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%）。