Tran Minh N N, He Q, Ramalho A, Kaufhold A, Viljanen M K, Arvilommi H, Mertsola J
National Public Health Institute, Department in Turku, Finland.
Pediatrics. 1999 Dec;104(6):e70. doi: 10.1542/peds.104.6.e70.
To evaluate the immunogenicity and reactogenicity of an acellular pertussis vaccine (pa) either formulated with diphtheria and tetanus toxoids (dTpa) or administered consecutively with a licensed tetanus and diphtheria vaccine (Td) as a 5th dose in adolescents.
A total of 510 healthy children 10 to 13 years of age were assigned randomly, using a single-blind design, to receive either the dTpa vaccine or the Td vaccine with the pa vaccine 1 month later. The quantities of 3 pertussis antigens (pertussis toxin, filamentous hemagglutinin, and pertactin) in the dTpa and the pa vaccines were one third of those of the Infanrix vaccine (SmithKline Beecham Biologicals, Rixensart, Beligium) licensed for use in infants. For enzyme-linked immunosorbent assay measurement of serum immunoglobulin G antibodies and proliferation assay of peripheral blood mononuclear cells, blood samples were obtained before and 1 month after immunization. Local and systemic reactions were recorded on diary cards for 15 days after immunization.
After immunization with dTpa or pa, significant and comparable rises in geometric mean values of antibodies (12- to 46-fold) and proliferations (8- to 18-fold) to each of the pertussis antigens were noted. After immunization with dTpa or Td, significant rises in geometric mean values of antidiphtheria and antitetanus antibodies (35- to 76-fold) were noted, and all subjects had values of these antibodies >/=.1 international units/mL. The dTpa and pa vaccines were at least as well tolerated as the licensed Td vaccine.
Booster immunization of adolescents with an acellular vaccine containing reduced quantities of pertussis antigens in addition to diphtheria and tetanus toxoids induces good responses in both arms of the immune system without an increase in adverse reactions.
评估白喉破伤风无细胞百日咳疫苗(pa)与白喉破伤风类毒素联合制剂(dTpa),或在青少年中作为第5剂与已获许可的破伤风和白喉疫苗(Td)连续接种时的免疫原性和反应原性。
采用单盲设计,将510名10至13岁的健康儿童随机分组,一组接种dTpa疫苗,另一组1个月后接种Td疫苗及pa疫苗。dTpa和pa疫苗中3种百日咳抗原(百日咳毒素、丝状血凝素和百日咳黏附素)的含量是已获许可用于婴儿的Infanrix疫苗(比利时里克斯圣的史克必成生物制品公司)的三分之一。为通过酶联免疫吸附测定法检测血清免疫球蛋白G抗体及进行外周血单个核细胞增殖测定,在免疫前和免疫后1个月采集血样。免疫后15天,在日记卡上记录局部和全身反应。
接种dTpa或pa后,观察到针对每种百日咳抗原的抗体几何平均值(升高12至46倍)和增殖水平(升高8至18倍)均有显著且相当的升高。接种dTpa或Td后,抗白喉和抗破伤风抗体的几何平均值有显著升高(升高35至76倍),且所有受试者这些抗体的值均≥0.1国际单位/毫升。dTpa和pa疫苗的耐受性至少与已获许可的Td疫苗相同。
青少年用除白喉和破伤风类毒素外百日咳抗原含量降低的无细胞疫苗进行加强免疫,可在免疫系统的两个方面诱导良好反应,且不会增加不良反应。