无细胞百白破b型流感嗜血杆菌联合疫苗与脊髓灰质炎疫苗联合接种的安全性和免疫原性观察

Safety and immunogenicity of diphtheria,tetanus,acellular pertussis and Haemophilus influenzae type b combined vaccine co-administered with poliomyelitis vaccines

目的评价适龄儿童无细胞百白破b型流感嗜血杆菌联合疫苗(DTaP-Hib)与口服脊髓灰质炎减毒活疫苗(OPV)或灭活疫苗(IPV)联合接种的安全性和免疫原性。方法在两个地区招募3月龄儿童,按3-4-5月龄免疫程序单独接种DTaP-Hib,或联合接种OPV、IPV,观察接种后0-28d不良事件,检测免疫前和全程免疫后28d血清百日咳毒素(PT)、百日咳丝状血凝素(FHA)、白喉毒素(DT)、破伤风毒素(TT)和b型流感嗜血杆菌(Hib)抗体,分析不良事件发生率和抗体阳转率。结果在3416名(接种20334剂次)DTaP-Hib与脊灰疫苗联合接种和508名(接种1408剂次)DTaP-Hib单独接种的受试者中,不良事件发生率分别为7.62‰、17.05‰(95%CI:6.43‰-8.82‰、15.27‰-18.83‰);在25名DTaP-Hib与OPV联合接种、97名DTaP-Hib与IPV联合接种、22名DTaP-Hib单独接种的受试者中,免疫后PT抗体阳转率均为100%(95%CI:86.28%-100%、96.27%-100%、84.56%-100%),FHA抗体分别为100%、93.81%、95.45%(95%CI:86.28%-100%、87.02%-97.70%、77.16%-99.88%),DT抗体分别为88.00%、92.78%、95.45%(95%CI:68.78%-97.45%、85.69%-97.05%、77.16%-99.88%),TT抗体分别为96.00%、91.75%、81.82%(95%CI:79.65%-99.90%、84.39%-96.37%、59.72%-94.81%),Hib抗体分别为88.00%、84.54%、77.27%(95%CI:68.78%-97.45%、75.78%-91.08%、54.63%-92.18%)。结论DTaP-Hib与IPV或OPV联合接种与单独接种相比未增加不良事件发生率且免疫原性相当。

Objective To assess the safety and immunogenicity of diphtheria,tetanus,acellular pertussis and Haemophilus influenzae type b combined vaccine(DTaP-Hib)co-administered with oral poliomyelitis attenuated live vaccine(OPV)or inactivated poliovirus vaccine(IPV).Methods We recruited 3-month-old children in two settings and vaccinated consented infants with standalone DTaP-Hib or with DTaP-Hib and OPV or IPV given simultaneously in the standard 3-4-5-month schedule.We observed for adverse events within 28 days of vaccination to determine incidences of adverse events and tested serum samples for antibodies against pertussis toxin(PT),pertussis filamentous hemagglutinin(FHA),diphtheria toxin(DT),tetanus toxin(TT)and Haemophilus influenzae type b(Hib)before and 28 days after vaccination to determine seroconversion rates.Results 3416 subjects received a total of 20334 doses of DTaP-Hib and OPV or IPV simultaneously and 508 subjects received 1408 doses of standalone DTaP-Hib;incidences of adverse events after vaccination for the two groups were 7.62‰and 17.05‰(95%CI:6.43‰-8.82‰and 15.27‰-18.83‰),respectively.Among 25 subjects that received co-administered DTaP-Hib and OPV,97 subjects that received co-administered DTaP-Hib and IPV,and 22 subjects that received standalone DTaP-Hib,seroconversion rates were all 100%for PT antibody(95%CI:86.28%-100%,96.27%-100%,and 84.56%-100%);were 100%,93.81%,and 95.45%for FHA antibody(95%CI:86.28%-100%,87.02%-97.70%,and 77.16%-99.88%);were 88.00%,92.78%,and 95.45%for DT antibody(95%CI:68.78%-97.45%,85.69%-97.05%,and 77.16%-99.88%);were 96.00%,91.75%,and 81.82%for TT antibody(95%CI:79.65%-99.90%,84.39%-96.37%,and 59.72%-94.81%);and were 88.00%,84.54%,and 77.27%for Hib antibody(95%CI:68.78%-97.45%,75.78%-91.08%,and 54.63%-92.18%).Conclusions DTaP-Hib co-administered with IPV or OPV was not associated with an increase in incidence of adverse events and had similar immunogenicity compared with standalone DTaP-Hib vaccination.