PDF(Pubmed)
Abstract：
As global supply is still inadequate to address the worldwide requirements for HPV vaccines, we assessed the safety and immunogenicity of a new bivalent HPV16/18 vaccine. In this randomized, double-blind, placebo-controlled, phase 2 trial, healthy 9-45-year-old Chinese females in three age cohorts (600 aged 9-17 years; 240 aged 18-26 years; 360 aged 27-45 years) were randomized 1:1 to receive three doses (0,2,6 months) of HPV16/18 vaccine or placebo. We measured neutralizing antibodies against HPV 16 and 18 at 7 months and monitored safety to 12 months in all age cohorts; 9-17-year-old girls were monitored for safety and immunogenicity to 48 months. In vaccinees, 99.8% seroconverted for HPV 16 and 18 types at 7 months; respective GMTs of 5827 (95% CI: 5249, 6468) and 4223 (3785, 4713) were significantly (p < .001) higher than controls for all comparisons. GMTs in the 9-17-year-olds, which were significantly higher than in older women at 7 months, gradually declined to 48 months but remained higher than placebo with seropositivity rates maintained at 98.5% and 97.6% against HPV 16 and 18, respectively. Adverse events occurred at similar rates after vaccine and placebo (69.8% vs. 72.5%, p = .308), including solicited local reactions and systemic adverse events which were mainly mild-to-moderate. The bivalent HPV16/18 vaccine was well tolerated and induced high levels of neutralizing antibodies in all age groups which persisted at high levels to 48 months in the 9-17-year-old age group which would be the target for HPV vaccination campaigns.
摘要：
由于全球供应仍然不足以满足全球对HPV疫苗的需求，我们评估了一种新型双价HPV16/18疫苗的安全性和免疫原性.在这个随机的，双盲,安慰剂对照,第二阶段试验，3个年龄组(600名9~17岁;240名18~26岁;360名27~45岁)中的9~45岁健康中国女性以1:1的比例随机分组,接受3剂(0,2,6个月)HPV16/18疫苗或安慰剂.我们在7个月时测量了针对HPV16和18的中和抗体，并在所有年龄组中监测了12个月的安全性；监测了9-17岁女孩的安全性和免疫原性到48个月。在疫苗接种者中，在7个月时，HPV16和18型的血清转化率为99.8%；在所有比较中，5827(95%CI:5249,6468)和4223(3785,4713)的GMT均显著高于对照组(p<.001)。9-17岁儿童的GMT，明显高于7个月时的老年女性，逐渐下降至48个月,但仍高于安慰剂,HPV16和18的血清阳性率分别维持在98.5%和97.6%.接种疫苗和安慰剂后不良事件发生率相似(69.8%vs.72.5%,p=.308)，包括主要为轻度至中度的局部应诉反应和全身不良事件.二价HPV16/18疫苗在所有年龄组中具有良好的耐受性并诱导高水平的中和抗体,其在9-17岁年龄组中持续高水平至48个月,这将是HPV疫苗接种运动的目标。
