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目的 :研究HPV6bL1病毒样颗粒 (VLP)治疗儿童喉乳头状瘤 (JLP)的安全性和免疫原性。方法 :应用基因工程制备的HPV6bL1VLP 5、10、2 5 μg 3种剂量递增方法对 10例严重复发性JLP患儿进行免疫接种 ,记录不良反应及行血、尿常规和生化检测 ,ELISA法检测血清特异性HPV6bL1VLP抗体 ,对 7例患儿进行迟发性超敏反应 (DTH)试验 ,纤维喉镜随访观察喉部病变情况。结果 :接种后患儿无局部和全身不良反应 ,血清均能产生特异性的中和抗体 ,接种前 3天和 3种剂量完成后及开始治疗 1年后的血清抗体吸收度A均值分别为 0 .110± 0 .0 35 ,0 .310± 0 .0 12 ,0 .5 87± 0 .0 12 ,0 .75 2± 0 .0 19,0 .772± 0 .0 13。第 1剂量完成后与接种前 3天A均值比较 ,第 2剂量与第 1剂量完成后比较 ,第 3剂量与第 2剂量完成后比较 ,接种 1年后与对照组比较 ,各组间差异均有统计学意义 (均P <0 .0 1)。 7例行DTH试验的患儿均呈阳性反应。经免疫治疗后的 10例患儿未见复发。结论 :HPV6bL1VLP对JLP具有安全性和免疫原性 ,可成为防治JLP的有效疫苗。
Objective: To study the safety and immunogenicity of HPV6bL1 virus-like particles (VLP) in the treatment of children with laryngeal papilloma (JLP). Methods: Ten cases of severe recurrent JLP were immunized with 3 doses of HPV6bL1 VLP 5,10,25 μg by genetic engineering. The adverse reaction, blood routine, urine routine and biochemical test were recorded. Serum Specific HPV6bL1VLP antibody, 7 cases of children with delayed hypersensitivity (DTH) test, laryngoscope follow-up observation of laryngeal lesions. Results: There was no local and systemic adverse reactions after inoculation in children. Serum was able to produce specific neutralizing antibodies. The mean of serum antibody A after 3 days and 3 doses before and after 1 year of treatment was 0 .110 ± 0 .0 35, 0 .310 ± 0 .0 12, 0 .5 87 ± 0 .0 12, 0 .75 2 ± 0 .0 19,0 .772 ± 0 .0 13. After the first dose and the first three days before inoculation A comparison, the second dose and the first dose after the completion of the third dose and the second dose after the completion of comparison, one year after inoculation compared with the control group, the differences between the groups were There was statistical significance (all P <0.01). 7 cases of children with DTH test showed a positive response. No recurrence was seen in 10 children after immunotherapy. Conclusion: HPV6bL1VLP is safe and immunogenic against JLP and can be an effective vaccine against JLP.