Valasoulis George, Pouliakis Abraham, Michail George, Kottaridi Christine, Spathis Aris, Kyrgiou Maria, Paraskevaidis Evangelos, Daponte Alexandros
Department of Obstetrics & Gynaecology, University Hospital of Larisa, Mezourlo, 41334 Larisa, Greece.
Hellenic National Public Health Organization-ECDC, Marousi, 15123 Athens, Greece.
Cancers (Basel). 2020 May 5;12(5):1164. doi: 10.3390/cancers12051164.
The objective of this study was to investigate the hypothesis that HPV vaccination administered in patients with low-grade (LG) cytology shortly after an initial colposcopic assessment could prospectively alter HPV-related biomarkers. This was a prospective pilot observational study involving women attending a colposcopy clinic for evaluation of abnormal LG cytology that were advised to undergo HPV vaccination and proceeded accordingly. These women were compared with a matched unvaccinated group. Women requiring cervical biopsies or CIN treatment were excluded.
A full three-dose HPV vaccination was undertaken with either the 2-valent or the 4-valent anti-HPV VLP vaccine. LBC samples were obtained prior and after the completion of the vaccination regimen and tested for HPV DNA genotyping (CLART-2 HPV test) and E6 and E7 mRNA (NASBA technique).
Alterations of HPV-related biomarkers at a colposcopy reassessment appointment 12 months later.
The -values, relative risk (RR), absolute relative risk (ARR), number needed to treat (NNT) and 95% confidence intervals for each biomarker in each group were assessed.
A total of 309 women were included in the analysis. One hundred fifty-two women received the vaccine. HPV vaccination reduced in a statistically significant manner ( < 0.05) HPV DNA positivity rates for genotypes 16, 18, and 31, RR = 1.6 (95% CI: 1.1 to 2.3), RR = 1.7 (95% CI: 1.1 to 2.8), and RR = 1.8 (95% CI: 1.0 to 2.9), in women who only tested DNA-positive for HPV16, 18, and 31 genotypes, respectively, prior to vaccination. A less pronounced, statistically insignificant reduction was shown for women who tested positive for both HPV DNA and mRNA E6 and E7 expression for HPV16, 18, and 33 subtypes. Statistically significant reduction in HPV mRNA positivity was solely documented for genotype 31 ( = 0.0411).
HPV vaccination appears to significantly affect the rates of HPV16, 18, and 31 DNA-positive infections in the population testing HPV DNA-positive for the aforementioned genotypes. The above findings deserve verification in larger cohorts.
本研究的目的是调查以下假设：在初次阴道镜评估后不久，对低度（LG）细胞学患者进行人乳头瘤病毒（HPV）疫苗接种可前瞻性地改变HPV相关生物标志物。这是一项前瞻性试点观察性研究，涉及到前往阴道镜诊所评估异常LG细胞学且被建议并相应接受HPV疫苗接种的女性。将这些女性与匹配的未接种疫苗组进行比较。需要进行宫颈活检或CIN治疗的女性被排除。
采用二价或四价抗HPV病毒样颗粒（VLP）疫苗进行完整的三剂HPV疫苗接种。在疫苗接种方案完成之前和之后获取液基细胞学（LBC）样本，并进行HPV DNA基因分型检测（CLART-2 HPV检测）和E6及E7信使核糖核酸（mRNA）检测（核酸序列扩增技术，NASBA）。
在12个月后的阴道镜重新评估预约时，HPV相关生物标志物发生了改变。
评估了每组中每个生物标志物的P值、相对风险（RR）、绝对相对风险（ARR）、治疗所需人数（NNT）以及95%置信区间。
共有309名女性纳入分析。152名女性接种了疫苗。对于接种疫苗前仅HPV16、18和31基因型DNA检测呈阳性的女性，HPV疫苗接种以统计学显著方式（P<0.05）降低了16、18和31基因型的HPV DNA阳性率，RR分别为1.6（95%CI：1.1至2.3）、1.7（95%CI：1.1至2.8）和1.8（95%CI：1.0至2.
