Expert consensus on research and development strategy of therapeutic HPV vaccine
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.
Human papilloma virustherapeutic HPV vaccinedevelopment strategy