治疗性HPV疫苗研究开发策略专家共识

摘要/Abstract

摘要：

人乳头瘤病毒（HPV）是双链DNA病毒，高危HPV感染易引发宫颈癌及癌前病变风险。近年来，已有超过400多种不同亚型的HPV被鉴定出，大多数HPV感染是无症状的，可以自行消退。免疫系统正常的女性，从感染高危HPV开始，通常需要15～20年才能发展为宫颈癌；但是对于免疫系统较弱的女性，如未经治疗的HIV感染女性（WLHIV），宫颈癌可能发展得更快（可能5～10年）。2006年，预防性HPV疫苗研发上市，但对已感染HPV或癌前病变患者无治疗效果。治疗性HPV疫苗的开发可为目前预防和治疗宫颈癌的方法提供重要的补充。与预防性HPV疫苗不同，治疗性疫苗旨在诱导特异性细胞免疫而非体液免疫（中和抗体），用于清除或治疗现有的HPV感染及其引起相关的癌前病变和侵袭性宫颈癌。因此，制定合理的治疗性HPV疫苗开发策略，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。本课题组织领域内专家学者，参考有关文件，结合HPV临床特点和发展背景，特别编撰了《治疗性HPV疫苗研究开发策略专家共识》，明确了适应范围、相关术语等，重点阐述了治疗性HPV疫苗临床开发方向、研究人群及特性和接种规划，旨在加快和推进治疗性HPV疫苗的研发，为社会研究开发治疗性HPV疫苗产品以及国家制定治疗性HPV疫苗相关政策提供借鉴和参考。

关键词: 人乳头瘤病毒（HPV）, 治疗性HPV疫苗, 开发策略, 专家共识

Abstract:

Human papilloma virus （HPV） is a double-stranded DNA virus that high-risk HPV infection predisposes to the risk of cervical cancer and precancerous lesions. 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 women with a weaker immune system， 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.therapeutic HPV vaccine is different from prophylactic HPV vaccine， therapeutic HPV vaccine will induce specific cellular rather than humoral immunity （neutralizing antibodies），and be designed to clear or treat existing HPV infections， their associated precancerous lesions and invasive cervical cancer. Therefore， a reasonable therapeutic HPV vaccine development strategy will not only allow the HPV therapeutic 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.The therapeutic HPV vaccine working group gatherd experts and scholars in the field， referred to related publications， combined with the clinical characteristics and background of HPV，compiled the "Expert Consensus on Research and Development Strategy of Therapeutic HPV Vaccin"， which the scope of adaptation and related terminology of the compilation was clarified， and the clinical development direction， research population， characteristic and vaccination plan of therapeutic HPV vaccine were emphasised， to accelerate and promote the research and development of therapeutic HPV vaccine. It provides reference for social research and development of therapeutic HPV vaccine products and the formulation of national policies related to therapeutic HPV vaccine.

［Key Words］

Key words: Human papilloma virus , （HPV）； , Therapeutic HPV vaccine； , Development strategy； , Expert consensus

中图分类号:

R737.33

李明珠, 赵超, 李静然, 赵昀, 李小平, 刘磊, 王洪东, 张秀军, 马丁, 魏丽惠.

治疗性HPV疫苗研究开发策略专家共识 [J]. 中国医药导刊, 2024, 26(5): 432-436.

LI Mingzhu, ZHAO Chao, LI Jingran, ZHAO Yun, LI Xiaoping, LIU Lei, WANG Hongdong, ZHANG Xiujun, MA Ding, WEI Lihui. Expert Consensus on Research and Development Strategie of Therapeutic HPV Vaccine[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2024, 26(5): 432-436.

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