Evaluation of safety and efficacy of basic immunization with different sequential immunization programs of polio vaccine
Objective To evaluate the safety and efficacy of basic immunization with different sequential immunization pro-grams of oral live attenuated poliomyelitis vaccine(OPV)and inactivated poliomyelitis vaccine(IPV).Methods Infants above two months of age residing in Pudong New Area,Shanghai,were selected for the study,and the basic immunization program of OPV full course(O-O-O group),sequential IPV and OPV(I-I-O group),and IPV full course(I-I-I group)were administered at 2,3 and 4 months of age,respectively.Relevant adverse reactions were proactively monitored by the parents of the participants via completing their own self-observation form after immunization.Before and after immunization,blood samples were collected from the upper arm vein,and the serum was separated.The neutralizing antibody levels of poliovirus in serum were measured by micro neutralization test,and the antibody positive rate and geometric mean titer(GMT)were calculated.Logistic multivariate regression analysis was used to research the effects of group,gender,household registration,birth mass and positive rate of type Ⅰ/Ⅲ antibody before immunization on the positive rate of type Ⅰ/Ⅲ antibody after basic imm-unization.Results There were one case of lethargy and one case of crying in O-O-O group,one case of lethargy in I-I-O group,and one case of crying in I-I-I group.The GMTs of type Ⅰ neutralizing antibody in the pre-immunization O-O-O group,I-I-O group,and I-I-I group were 41.39,8.21,and 12.56,and those of type Ⅲ neutralizing antibody were 7.57,4.02 and 8.08,respectively.There was no significant difference in GMT between groups for type Ⅰ and Ⅲ neutralizing antibodies before immu-nization(F=2.815 and 0.608,P=0.061 and 0.545,respectively).The positive rates of type Ⅰ antibody before immunization were 24.04％,34.07％and 41.00％,respectively,with significant difference between groups(x2=13.459,P=0.001).The positive rates of type Ⅲ antibody were 13.94％,9.89％and 18.00％,respectively,with no significant difference(x2=5.188,P=0.075).After immunization,the GMTs of type Ⅰ neutralizing antibody were 1 311.84,1 812.59 and 833.24,and those of type Ⅲ neutralizing antibody were 911.97,1 752.68 and 419.50,respectively,with significant differences between groups(F=76.848 and 202.632,respectively,each P＜0.001).After immunization,the positive conversion rates of type Ⅰantibody were 98.56％,100％and 100％,and those of type Ⅲ antibody were 99.04％,100％and 99.44％,respectively,with no significant difference between the two groups(x2=2.973 and 1.045,P=0.122 and 0.789,respectively).In addition,group,gender,household registration,birth mass and positive rate of type Ⅰ/Ⅲ antibody before immunization had no effect on the positive conversion rate of type Ⅰ/Ⅲ antibodyafter basic immunization.Conclusion All three sequential immunization pro-grams achieved good safety and high antibody positive conversion rates after basic immunization.
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