重组人乳头瘤病毒疫苗免疫原性检测方法的比较

目的评价重组人乳头瘤病毒(human papillomavirus,HPV)疫苗免疫原性2种检测方法的相关性。方法应用间接酶联免疫吸附(ELISA)法和假病毒中和(pseudovirion-based neutralization assay,PBNS)法对26份阴性血清样本、34份自然感染HPV16或HPV18的血清样本及30份接种HPV16/18型双价疫苗后7个月的血清样本进行抗体滴度检测,并采用Pearman进行相关性分析。结果 3组样本的抗HPV16型和HPV18型抗体滴度的2次检测结果比值显示,试验室内重复性较好;2种方法检测血清样本抗HPV16型抗体滴度的总体相关系数为0.826,抗HPV18型为0.921;自然感染HPV的血清样本抗HPV16型抗体滴度的相关系数为0.519,抗HPV18型为0.613;接种HPV16/18型双价疫苗后的血清样本抗HPV16型抗体滴度的相关系数为0.671,抗HPV18型为0.879。结论间接ELISA法和PBNS法在检测血清样本中抗HPV16/18型抗体滴度时均具有较好的重复性和相关性,其中以接种疫苗后的血清样本中抗体滴度相关性最佳,为HPV疫苗免疫原性的检测及剂量探索试验提供了参考依据。

Comparison of methods for determination of immunogenicity of recombinant human papillomavirus vaccine

Objective To assess the correlation between two methods for determination of immunogenicity of recombinant human papillomavirus(HPV) vaccine.Methods Enzyme-linked immunosorbent assay(ELISA) and pseudovirion-based neutralization assay(PBNS) were used to measure the anti-HPV 16 or anti-HPV 18 antibody levels in 26 negative serum samples,34 serum samples naturally infected with HPV16 or HPV18 and 30 serum samples 7 months after immunization with HPV16 / 18 bivalent vaccine,between which the correlation was analyzed by Pearman method.Results The ratio of results of two tests for HPV16 and HPV18 antibody titers in three groups of samples showed high intra-reproducibility.The total correlation coefficient of test results of HPV16 antibody titers by two methods was 0.826,while that of HPV18 antibody was 0.921.The correlation coefficient for HPV 16 antibody titer in naturally infected samples was 0.519,while that for HPV18 antibody titer was 0.613.However,the correlation coefficient for HPV 16 antibody titer in serum samples after immunization with HPV16 / 18 bivalent vaccine was 0.671,while that for HPV 18 antibody titer was 0.879.Conclusion Both ELISA and PBNS showed high reproducibility and correlation for determination of HPV16 / 18 antibody titers in serum samples,especially for those in samples after vaccination.It provided a reference for determination of immunogenicity and optimization of dosage of HPV vaccine.