Lacey C J, Thompson H S, Monteiro E F, O'Neill T, Davies M L, Holding F P, Fallon R E, Roberts J S
Department of Genitourinary Medicine and Communicable Diseases, Imperial College School of Medicine, St. Mary's Hospital, London W2 1PG, United Kingdom.
J Infect Dis. 1999 Mar;179(3):612-8. doi: 10.1086/314616.
A fusion protein vaccine consisting of human papillomavirus 6 L2E7 with Alhydrogel was developed for the treatment of genital warts. Twenty-seven subjects with genital warts received 3 immunizations over 4 weeks in an open-label study. The vaccine was well-tolerated, and all subjects made serum IgG antibodies, predominantly IgG1, against L2E7. Nineteen of 25 tested persons made antigen-specific T cell proliferative responses to L2E7, and peripheral blood mononuclear cells when cultured with L2E7 in vitro produced both interferon-gamma and interleukin (IL)-5, although IL-5 predominated after the final vaccination. Five subjects completely cleared warts within 8 weeks. Subjects whose warts were not cleared by 8 weeks were offered conventional therapy. Recurrence of warts was not seen in any of the 13 persons whose warts cleared by vaccine alone or with conventional therapy. While these preliminary results of the use of this therapeutic immunogen are encouraging, proof of efficacy will require randomized double-blind trials.
一种由人乳头瘤病毒6 L2E7与氢氧化铝佐剂组成的融合蛋白疫苗被研发用于治疗尖锐湿疣。在一项开放标签研究中，27名尖锐湿疣患者在4周内接受了3次免疫接种。该疫苗耐受性良好，所有受试者均产生了针对L2E7的血清IgG抗体，主要为IgG1。25名受试人员中有19人对L2E7产生了抗原特异性T细胞增殖反应，外周血单个核细胞在体外与L2E7一起培养时产生了干扰素-γ和白细胞介素（IL）-5，尽管在最后一次接种后IL-5占主导。5名受试者在8周内完全清除了疣体。疣体在8周内未清除的受试者接受了传统治疗。在仅通过疫苗或与传统治疗清除疣体的13人中，没有一人出现疣体复发。虽然使用这种治疗性免疫原的这些初步结果令人鼓舞，但疗效的证明还需要随机双盲试验。
