HPV6b病毒样颗粒免疫治疗儿童喉乳头状瘤临床初步研究

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。

Clinical pilot study of HPV6b L1 virus-like particles as immune therapy for juvenile larynx papillomatosis

OBJECTIVE: To study the safety and the immunogenicity of HPV6b virus-like particles (VLP) in children with juvenile laryngeal papilloma (JLP). The result of therapy is observed. METHOD: HPV6b VLP were expressed with HPV6b L1 recombinant baculovirus in sf-9 insect cells. Ten case of recurrent JLP were immunized with HPV6b VLP in 5, 10, 25 microg doses progressively and any local or systemic adverse events were recorded. By ELISA was used to detect the serum HPV6b VLP antibody (Ab) of JLPs samples in therapy different stage. Seven cases of JLP were used DTH test. To understand the effects of VLP on disease prognosis subjects will be examined by fibrolaryngoscope. RESULT: All subjects did not experience local or systemic adverse events and specific serum antibody against HPV6b L1VLP was produced in JLP immunized. The A value of sera antibody in the first dose group have completed (0.310 +/- 0.012) were higher than that of pro-immune (0.110 +/- 0.035) (t = 4.673, P < 0.01). There was a significant difference of serum mean HPV6b Ab A value between JLP's patients immunized (0.772 +/- 0.013) and the control group (0.153 +/- 0.014) (t = 15.45, P < 0.01), 7 samples have male response of DTH test. All patients didn't recurrent papilloma after receiving treatment. CONCLUSION: HPV6b VLP have immunogenicity and safety as therapy for JLP patients, and HPV6b VLP may be used in prophylactic and therapeutic vaccine for JLP.