国产重组酵母乙型肝炎疫苗人体免疫效果研究

A Study on immunogenicity of recombinant yeast-derived hepatitis B wacci ne to medical school students

〔目的〕为了进一步了解国产重组酵母乙肝疫苗的免疫效果。〔方法〕对 2 19名HBV感染阴性卫校学生按 0、1、6方案接种国产重组酵母乙肝疫苗 ,接种后 7个月、12个月、2 4个月、36个月、48个月不同时间取静脉血 ,采用RIA法、ELISA法分别检测抗 -HBs和HBsAg。同时与 16 2名HBV感染阴性学生比较HBV感染率。〔结果〕全程免疫后 ,2 19人中2 0 0人抗 -HBs>10mlU/ml,接种疫苗后 4年中 2 19人HBV感染率为 1.37% (3/ 2 19)。未接种疫苗组 16 2人HBV感染率为6 .17% (10 / 16 2 )。〔结论〕国产重组酵母乙肝疫苗有较好的免疫效果 ,抗 -HBs阳转率可达 91.32 %。与对照组比较 ,接种疫苗组HBV感染率明显低于对照组 ,有差异显著性。因此 ,认为国产重组酵母乙肝疫苗具有较好的免疫源性和保护性免疫效果 ,可用于替代乙肝血源疫苗广泛使用。

Objective〕 To evaluate the immunogenicity of recombina nt yeast-derived hepatitis B vaccine.〔Method〕 219 medical school s tudents with negative HBV test were vesults randomly selected as subjects. Usi ng 0, 1 and 6 months im munization program, cach subjcct was injected with 5μg/0.5ml recombinant vaccin e of hepatitis B produced in China each time. 〔Result〕 There wer e 200 subjects whose anti-HBs titers were above 10 mlU/ml after complete immuniz ation, the protective efficacy was 91.32%(200/219). There were 3 subjects was i nfected by HBV affter four yeas of immunization. Infection rates is 1.37%(3/21 9). There were 10 subjects infected BY HBV among the 162 subjectswithout valline injection Infection rates is 6.17%(10/162). 〔Conclusions〕 The protection efficacy of yeast-derived recombinant vaccine of hepatitis B prod uced in China reaches 91.32%. HBV infection rates in group with vaccine injec tiou was lower than in that without. HBV infection rates between the two groups was obvious different. Immunogenicity of yeast-derived rccombin ant vaccinc of hepatitis B produced in China is effective.