Objective To investigate the safety, efficacy and immunization schedule of whole cell DTP combined with hepatitis B vaccine(CHO)produced by Wu Han National Biological Institute.
Methods Two phases were included in this trial.Three groups were included in the first phase.Group 1(30)was immunized with wDTP-HBV(CHO)according to 2, 4, 6 month schedule; group 2(30)was immunized wD TP-HBV(CHO)according to 3, 4, 5 month; group 3(31)was immunized wDTP vaccine according to 3, 4, 5 month.Phase 2 was also divided into 3 groups.Group 1(113)was immunized with wDTP-HBV according to 2, 4, 6 schedule; Group 2(113)was immunized with wDTP control vaccine in upper left arm, and HBV control vaccine on the upper right arm; Group 3(101)immunized with control HBV vaccine according to 0, 1, 6 month and DTP control vaccine according to 3, 4, 5 month.
Results The body temperature of 1 child in group 1 and group 2 increased weakly, the rate was 3.3% among the whole group in phase 1 trial.In phase 2 trial, there were 4 and 5 children had mild side reaction in group 1(3.1%), 2(4.2%)respectively; 14 children had weak side reaction in group 3, the rate was 12.2%.No serious side reaction was found in phase 1 and 2.The antibody titer of all samples collected before the first dose and after the last dose were measured, the result showed that the sero-conversion of anti-diphtheria, anti-tetanus and anti-HBV antibody were 100%, > 85% for anti-pertusis antibody.The statistics analysis showed that all the antibody level of the samples before and after immunization had significant difference.The comparison of the antibody level among 3 groups showed that the new wDTP-HBV vaccine had good ability to induce effective antibody.
Conclusion This study result certified that the new adsorbed whole cell DTP and HBV(CHO)combined vaccine had good safety and efficacy, and can be used for the immunization.The new 2, 4, 6 immunization schedule was also able to induce enough antibody level for diphtheria, pertusis, tetanus and hepatitis B virus.
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