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为了评价以Alhydrogel为吸附剂的重组6型人乳头状瘤病毒（HPV6）L2E7融合蛋白疫苗的免疫原性及安全性,作者对42名健康男性志愿者进行了随机、双盲、安慰剂- 对照的Ⅰ期临床试验。将研究对象分为对照组（6人）和3个接种组（每组12人）,分别肌注重组L2E7疫苗3、30及300μg。其中各剂量疫苗组又随机分为两个小组（每组6人）,分别按0、1、4周程序（快速程序）和0、4、8周程序（经典程序）接种疫苗。快速程序组分别于第0、1、4、8和32周采血,经典程序组分别于第0、2、4、8、10和32周采血。通过检测体外L2E7特异性T淋巴细胞增殖应答、γ干扰素（IFN-γ）和白细胞介素5（IL-5）的分泌量及血清抗L2E7抗体评价疫苗的免疫原性。
In order to evaluate the immunogenicity and safety of recombinant human HPV 6 L2E7 fusion protein vaccine with Alhydrogel as adsorbent, 42 healthy male volunteers were randomized, double-blind, placebo-controlled Phase I clinical trial. Subjects were divided into control group (6) and 3 inoculation groups (12 in each group). The animals were given 3, 30 and 300 μg of L2E7 vaccine intramuscularly respectively. Each dose vaccine group was randomly divided into two groups (6 in each group), which were vaccinated according to 0, 1 and 4 weeks program (fast program) and 0, 4 and 8 weeks program (classical program) respectively. Blood samples were collected on weeks 0, 1, 4, 8 and 32 respectively in the fast program group, and blood was collected on week 0, 2, 4, 8, 10 and 32 in the classical program group. The immunogenicity of the vaccine was evaluated by measuring the in vitro L2E7-specific T lymphocyte proliferation response, secretion of IFN-γ and interleukin 5 (IL-5), and serum anti-L2E7 antibody.