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受试者为1685名婴儿,随机分为3组:口服脊髓灰质炎疫苗(OPV)组:出生、6、10、14周龄时各服用一次OPV;OPV和脊髓灰质炎灭活疫苗(IPV)联合免疫组:出生时用OPV,6、10、14周龄时合用IPV和OPV;IPV组:出生时间安慰剂,6、10、14周龄时用IPV.每剂三价OPV含1、2和3型脊髓灰质炎病毒量分别为:10~6、10~5和10~(5.5)半数组织培养感染量(TCID_(50)),每剂IPV1、2和3型病毒含量分别为:40、8、32D抗原单位.收集14和24周龄的指血和静脉血1ml,以测定中和抗体滴度,收集脐带血样以测定母体抗体水平.血样一式三份,用改良的微量中和试验测定抗各型脊髓灰质炎病毒抗体滴度.24周龄时用10~6TCID_(50).剂量的Ⅰ型单价OPV进行攻击,接种后粪便样本用聚合酶链反应法作Sabin株特异性探针检查.
The subjects were 1685 infants and were randomly assigned to one of three groups: oral polio vaccine (OPV) group: OPV at birth, 6, 10 and 14 weeks of age; OPV and poliomyelitis inactivated vaccine (IPV) Combined immunization group: OPV at birth, IPV and OPV at 6, 10 and 14 weeks of age; IPV group: placebo at birth, IPV at 6, 10 and 14 weeks OPV containing 1,2 And poliovirus type 3 were 10 ~ 6, 10 ~ 5 and 10 ~ (5.5), respectively. The infection rates of TCID_ (50) and IPV1, 2 and 3 viruses per dose were 40 , 8,32D antigen units Blood and venous blood from 14 and 24 weeks old were collected at 1 ml to determine the neutralizing antibody titer and umbilical cord blood samples were collected to determine maternal antibody levels.The blood samples were tested in triplicate with a modified micro neutralization test The anti-poliovirus antibody titers were determined and challenged with 10-6 TCID 50 dose of type I monovalent OPV at 24 weeks of age. The stool samples were used for polymerase chain reaction an examination.