一剂人乳头瘤病毒疫苗是否与三剂一样有效?:国家队列分析

Julia ML. Brotherton , Alison Budd , Christopher Rompotis , Natasha Bartlett , Michael J. Malloy , Rachael L. Andersen , Kim AR. Coulter , Peter W. Couvee , Nerida Steel , Gail H. Ward , Marion Saville
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引用次数: 71

摘要

预防性人乳头瘤病毒(HPV)疫苗在三次注射时对预防宫颈癌前病变非常有效。一些事后试验数据表明,一剂疫苗可以预防HPV感染。如果一剂疫苗就能预防宫颈癌前病变,那么将大大促进全球宫颈癌预防工作。我们评估了四价HPV疫苗在澳大利亚接种疫苗后7年内预防宫颈上皮内瘤变(CIN) 2或3/原位腺癌(AIS)/癌症的剂量数量。方法:我们将所有8个管辖区宫颈筛查登记处的登记数据与2007年4月(开始接种疫苗时)至2014年12月31日期间接受疫苗筛查的所有15岁或以下澳大利亚妇女的全国HPV疫苗接种登记册、死亡指数和癌症登记册相关联。我们进行了Cox比例风险回归,对年龄、社会经济地位和居住地区进行了先验调整,以估计组织学证实的CIN2/CIN3/AIS/癌症的风险比。结果纳入250,648例妇女:未接种疫苗48,845例(19.5%),接种三剂疫苗174,995例(69.8%),接种两剂疫苗18,190例(7.3%),接种一剂疫苗8,618例(3.4%)。与未接种疫苗的妇女相比,所有剂量组(1剂0.65 (95%CI 0.52 - 0.81)、2剂0.61 (95%CI 0.52 - 0.72)和3剂0.59 (95%CI 0.54 - 0.65)的校正风险比均显著降低。在接种疫苗组中调整接种年龄后,一剂和两剂接种者的调整风险比与三剂接种者相当(一剂1.01 (95%CI 0.81-1.26),两剂1.00(0.85-1.17))。多重敏感性分析,包括使用不同的剂量分配方法,得出了一致的结果。与历史上年龄匹配的女性队列比较表明,结果并不仅仅是由于群体保护。结论在高覆盖率的环境下,1剂与2剂或3剂预防高级别疾病的效果相当。这些发现支持了一种假设,即在全球消除宫颈癌的工作中,一剂疫苗接种可能是一种可行的策略。
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Is one dose of human papillomavirus vaccine as effective as three?: A national cohort analysis

Aim

Prophylactic human papillomavirus (HPV) vaccines are highly effective at preventing pre–cancerous cervical lesions when given in a three–dose schedule. Some post–hoc trial data suggest that one dose prevents HPV infection. If one dose could prevent pre–cancerous cervical lesions, then global cervical cancer prevention would be greatly facilitated. We assessed the effectiveness of quadrivalent HPV vaccine by number of doses against cervical intraepithelial neoplasia (CIN) 2 or 3/adenocarcinoma–in–situ (AIS)/cancer in Australia up to seven years post vaccination.

Methods

We linked registry data from all 8 jurisdictional cervical screening registers, with the national HPV vaccination register, death index and cancer registers for all Australian women aged 15 or under when eligible for vaccine who screened between April 2007 (when vaccination commenced) and 31 December 2014. We performed Cox proportional hazard regression, adjusted a priori for age, socioeconomic status, and area of residence, to estimate hazard ratios of histologically confirmed CIN2/CIN3/AIS/cancer.

Results

We included 250,648 women: 48,845 (19·5%) unvaccinated, 174,995 (69·8%) had received three doses, 18,190 (7·3%) two doses and 8,618 (3·4%) one dose. The adjusted hazard ratio was significantly lower for all dose groups compared to unvaccinated women (1 dose 0·65 (95%CI 0·52–0·81), 2 doses 0·61 (0·52–0·72) and 3 doses 0·59 (0·54–0·65).) With adjustment for age at vaccination amongst the vaccinated group, the adjusted hazard ratios for one dose and two dose recipients were comparable to three dose recipients (one dose 1.01 (95%CI 0.81–1.26), two doses 1.00 (0.85–1.17).) Multiple sensitivity analyses, including use of different dose assignment methods, produced consistent findings. Comparison with a historical cohort of age matched women showed that the result was not due to herd protection alone.

Conclusions

One dose had comparable effectiveness as two or three doses in preventing high–grade disease in a high coverage setting. These findings support the hypothesis that one dose vaccination may be a viable strategy when working towards the global elimination of cervical cancer.

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来源期刊
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期刊介绍: The official Journal of the International Papillomavirus Society Papillomavirus Research (PVR), the Journal of HPV and other Small DNA Tumor Viruses publishes innovative papers related to all aspects of papillomaviruses and other small DNA tumor viruses. The official journal of the International Papillomavirus Society, PVR is an open access publication that aims to bring together virologists, immunologists, epidemiologists and clinicians working in the booming field of HPV and animal papillomaviruses, polyomaviruses and other small DNA tumor viruses and their associated diseases, in order to foster and facilitate interdisciplinary communication. The journal welcomes original research articles, reviews, short communications, opinion articles and regional update reports on papillomaviruses and other tumor viruses in the following sections: a. Biology of papillomaviruses and related viruses from life cycle to cancer b. Epidemiology etiology and natural history studies c. Natural and induced immunity including vaccine research d. Intervention studies and strategies including i. Clinical studies and trials ii. HPV treatments iii. HPV vaccination programs iv. Diagnostics and screening e. Infection and disease prevention, modeling studies f. Guidelines and public health recommendations g. HPV Studies in special populations Regional and local studies on these viruses.
期刊最新文献
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