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重组(汉逊酵母)乙型肝炎疫苗副反应和抗体应答观察 被引量:7

A study of safety and antibody responses for a new recombinant hepatitis B vaccine (Hansenula polymorpha)
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摘要 观察重组(汉逊酵母)乙肝疫苗免疫儿童的副反应和抗体应答。按0、1、6月免疫程序,分别应用2批重组汉逊酵母疫苗和2批重组酿酒酵母疫苗,免疫221名6至12岁儿童,其中汉逊酵母疫苗1批(A)接种102人,另一批(B)接种26人,重组酿酒酵母疫苗1批(C)和另1批(D)分别接种74和19人。观察每次接种后的副反应和全程免疫一月后(T7)的抗体应答。儿童接种汉逊酵母疫苗后副反应发生率低,有个别出现发热反应,但均低于37.8℃,且为一过性。T7时4组儿童抗HBs血清阳转率均在96%以上,GMT范围在229.98~338.83IU/L之间。免疫A批疫苗儿童组抗体滴度(GMT)显著高于免疫C批疫苗组(270.33、229.98IU/L;P<0.05)。汉逊酵母乙肝疫苗具有较好的安全性,免疫儿童抗体应答水平较高。 To evaluate the safety and antibody responses of the newly developed recombinant hepatits B vaccine(Hansenule polymorpha,HP vaccine),221 of 6 to 12 years old healthy children are vaccinated with HP vaccine and current recombinant HB vaccines according to 0,1,6 months schedule respectively.In which 102 and 26 of these children are injected with 1 lots(A)and another lot(B) of HP vaccines,while 74 and 19 children are received 1 lot(C)and another lot(D)HP vaccines.The results showed no serious side effects were found one month after vaccination. The body temperature elevated were transient and all below 37.8℃.Seroconvertion rates of anti HBs for 4 groups were all above 96%.The range of mean geometric titres(GMT)of anti HBs was from 229.98 to 338.83mIU/L. Therefor the recombinant HP vaccine is safety and high immunogenicity for applying to children vaccination.
出处 《微生物学免疫学进展》 2004年第4期4-6,共3页 Progress In Microbiology and Immunology
关键词 汉逊酵母 免疫原性 疫苗 Hansenule polymorpha Immunogenicity Vaccine
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  • 1Diminsky D, Schirmbeck, Reimann J, et al. Comparison between hepatitis B surface antigen (HBsAg) particles derived from mammalian cells (CHO)and yeast cells (Hansenula polymorpha):composition, structure and immunogenicity [J].Vaccine 1997, 15 (6/7):637-64
  • 2Kakrani A L, Bharadwaj R, Karmarkar A, et al. Immune responses induced by two dose strengths of an yeast-derived recombinant hepatitis B vaccine in adolescents[J]. Indian J Gastroenterology 2003, 22:71-72.

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