Borgoño J M, Corey G, Engelhardt H
Dev Biol Stand. 1976;33:80-4.
The article gives the results of the use of two types of killed oral typhus vaccine administered to students 10 to 19 years of age in two urban areas of the Province of Santiago. Vaccine from the German Democratic Republic (GDR) was administered to 37,517 students and placebo to an equivalent control group. The period of observation was 18 months (November 1973-April 1975). The other product, from the German Federal Republic (GFR) was administered to 37,566 students, with placebo given to an equivalent control group. In this case the observation period was 7 months (October 1974-April 1975). The antigenic composition of the two vaccines is qualitatively and quantitatively different as are the characteristics of their preparation. In the field trial with the product from the GDR, the morbidity for typhoid fever in the vaccinated and control groups showed statistically significant differences, even though on the border line level. Satisfactory and highly significant results had been obtained with the product in earlier field trials. The difference observed between morbidity in the two groups in the field trial with GFR vaccine was not significant. It is emphasized in this regard that the observation period was shorter in this case, which precludes definitive conclusions. A high proportion of reliable confirmation of diagnosis of cases is evident for both field trials. The findings show the need for subjecting this type of vaccine to further and better field trials.
本文给出了在圣地亚哥省两个市区对10至19岁学生使用两种类型的伤寒灭活口服疫苗的结果。给37517名学生接种了来自德意志民主共和国(东德)的疫苗,并给一个同等规模的对照组接种了安慰剂。观察期为18个月(1973年11月至1975年4月)。另一种产品来自德意志联邦共和国(西德),给37566名学生接种了该疫苗,并给一个同等规模的对照组接种了安慰剂。在这种情况下,观察期为7个月(1974年10月至1975年4月)。两种疫苗的抗原成分在质量和数量上均有差异,其制备特点也不同。在使用东德产品的现场试验中,接种组和对照组的伤寒发病率显示出统计学上的显著差异,尽管处于临界水平。在早期的现场试验中,该产品已取得了令人满意且高度显著的结果。在使用西德疫苗的现场试验中,两组发病率之间的差异不显著。在这方面需要强调的是,这种情况下观察期较短,这使得无法得出明确结论。对于这两项现场试验,病例诊断的可靠确认比例都很高。研究结果表明,需要对这类疫苗进行进一步且更好的现场试验。