COMPARATIVE-STUDY OF LEDERLE TAKEDA ACELLULAR AND LEDERLE WHOLE-CELL PERTUSSIS-COMPONENT DIPHTHERIA-TETANUS-PERTUSSIS VACCINES IN INFANTS IN GERMANY
COMPARATIVE-STUDY OF LEDERLE TAKEDA ACELLULAR AND LEDERLE WHOLE-CELL PERTUSSIS-COMPONENT DIPHTHERIA-TETANUS-PERTUSSIS VACCINES IN INFANTS IN GERMANY
复制标题
DOI：
10.1016/0264-410x(94)90014-0
复制
发表时间：
1994-01-01
期刊：
影响因子：
5.5
通讯作者：
STEHR, K
中科院分区：
文献类型：
--
作者：
HEININGER, U;CHERRY, JD;STEHR, K
为准备在德国进行大规模疗效试验，1990年12月启动了一项试点研究。本研究共入选149名婴幼儿，采用双盲随机法，75例接种Lederle/Takeda无细胞百日咳疫苗(APDT)，74例接种Lederle全细胞百日咳疫苗(DTP)。第一次接种的平均年龄为3.5月，第二次和第三次接种的间隔时间为6周。两种疫苗的反应相对较轻，一般在APDT后反应较少。两组对淋巴细胞增多促进因子(LPE)和菌毛-2的抗体应答相似，而APDT接受者对Pertactin和FHA的应答较强。TP接受者对破伤风和白喉类毒素的反应更强。当检查第一次接种的年龄(8-12周与16-20周)时，发现年轻年龄对DTP患者的抗体反应有抑制作用，但对APDT受者对LPF环、Pertactin、菌毛-2、破伤风和白喉环的抗体反应没有抑制作用。胎盘获得性抗体的高值降低了DTP受者对LPF环和破伤风环的应答，以及APDT疫苗接种者对破伤风环的应答。APDT接种者对LPF环状、FHA和菌毛-2的免疫应答比DTP接种者更一致。在13%的DTP接受者中观察到对菌毛-2的IgA抗体应答，但没有APDT疫苗接种者。这种APDT疫苗广泛的免疫原性和温和的反应性证明了它在德国疗效试验中的使用是合理的。
In preparation for a large efficacy trial in Germany, a pilot study was initiated in December 1990. In this study 149 infants were enrolled; with double-blind randomization 75 received Lederle/Takeda acellular pertussis component diphtheria-tetanus-pertussis vaccine (APDT) and 74 received Lederle whole-cell pertussis component diphtheria-tetanus-pertussis vaccine (DTP). The mean age at first dose was 3.5 months, and the second and third doses followed at 6-week intervals. Reactions were relatively mild with both vaccines, in general they were less frequent following APDT The IgG antibody responses to lymphocytosis promoting factor (LPE) and fimbriae-2 were similar in both groups whereas the responses to pertactin and filamentous haemagglutinin (FHA) were greater in APDT recipients. TP recipients had greater responses to tetanus and diphtheria toxoids. When age of first dose was examined (8-12 weeks versus 16-20 weeks), it was found that young age had a suppressive effect on antibody responses in DTP but not APDT recipients to LPF toroid, pertactin, fimbriae-2, and tetanus and diphtheria toroids. High values of transplacentally acquired antibody lessened the response to LPF toroid and tetanus toroid in DTP recipients and to tetanus toroid in APDT vaccinees. The IgG immune response to LPF toroid, FHA and fimbriae-2 was found to be more uniform in APDT recipients than in DTP vaccinees. An IgA antibody response to fimbriae-2 was noted in 13% of DTP recipients but in no APDT vaccinees. The broad immunogenicity and mild reactogenicity of this APDT vaccine justifies its use in the German efficacy trial.