治疗性HPV疫苗研究开发策略专家共识
Expert consensus on research and development strategy of therapeutic HPV vaccine
赵超 1李明珠 1李静然 1赵昀 1李小平 1刘磊 2王洪东 2张秀军 2马丁 3魏丽惠1
作者信息
- 1. 北京大学人民医院妇产科,北京 100044
- 2. 北京循生免疫医学转化研究院,北京 102600
- 3. 华中科技大学同济医学院附属同济医院妇产科,武汉 430030
- 折叠
摘要
人乳头瘤病毒(HPV)是双链DNA病毒,几乎所有宫颈癌均由高危HPV感染引起.近年来,已有超过400多种不同亚型的HPV被鉴定出来,大多数HPV感染无症状,可以自行消退.免疫功能正常的女性,从感染高危HPV开始,通常需要15～20年才能发展为宫颈癌;但是免疫功能低下的女性,如未经治疗的HIV感染女性,宫颈癌可能发展得更快(大约5～10年).2006年,预防性HPV疫苗上市,但对已感染HPV或癌前病变患者无治疗效果.治疗性HPV疫苗的开发为预防和治疗宫颈癌的方法提供重要的补充.目前,治疗性HPV疫苗正处于早期临床研究阶段,与现有预防新感染的预防性HPV疫苗不同,治疗性疫苗将被设计用于清除或治疗现有的HPV感染及其相关的癌前病变和侵袭性宫颈癌.因此,制定合理的开发策略,不仅可以让治疗性HPV疫苗产品开发企业少走弯路,提高转化效率,而且可以使HPV感染及相关病变甚至癌变患者及早受益.本文重点阐述了治疗性HPV疫苗临床开发方向、研究人群、特性和接种规划,旨在加快和推进其研发,为开发治疗性HPV疫苗产品及国家制定相关政策提供借鉴和参考.
Abstract
Human papilloma virus(HPV)is a double-stranded DNA virus that causes almost all cervical cancers due to high-risk HPV infection.More than 400 different HPV subtypes have been identified in recent years,and most HPV infections are asymptomatic and resolve spontaneously.Women with a normal immune system,starting with high-risk HPV infection,usually take 15 to 20 years to develop cervical cancer,but for immunocompromised women,such as untreated women living with HIV(WLHIV),cervical cancer may progress more quickly(5 to 10 years).In 2006,prophylactic HPV vaccine was developed and marketed,but it has no therapeutic effect on patients who have been infected with HPV or precancerous lesions.The development of therapeutic HPV vaccine may provide an important complement to the current methods for the prevention and treatment of cervical cancer.Currently,the therapeutic HPV vaccine is in the early clinical trials,which is different from the existing HPV prophylactic vaccine to prevent new HPV infection,therapeutic HPV vaccine will be designed to clear or treat existing HPV infections,their associated precancerous lesions and invasive cervical cancer as well.Therefore,a reasonable therapeutic HPV vaccine development strategy will not only allow the therapeutic HPV vaccine product development enterprises to avoid detours and improve the transformation efficiency,but also benefit patients with HPV infection,related lesions and even cancer as soon as possible.With the goal of clearing infection and treating cervical precancerous lesions.The expert concensus focus on the clinical development direction,target population,characteristic and vaccination programme of therapeutic HPV vaccine,aiming to accelerate and promote the research and development of therapeutic HPV vaccine,and will provide reference for the development of therapeutic HPV vaccine products and the formulation of national policies related to therapeutic HPV vaccine.
关键词
人乳头瘤病毒/治疗性HPV疫苗/开发策略Key words
Human papilloma virus/therapeutic HPV vaccine/development strategy引用本文复制引用
基金项目
国家重点研发计划(2021YFC2701202)
北京市科技计划项目(Z231100004823028)
出版年
2024
NETL
NSTL
万方数据