The primary objective of this Phase 3 study is to demonstrate the vaccine's efficacy against relevant outcomes in healthy women above 18 years old at enrolment.
The secondary objectives are to evaluate the safety, immunogenicity, and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference in safety and immunogenicity among different lots. Approximately 6000 study subjects will be enrolled and randomly stratified into 2 groups and receive the human papillomavirus (HPV) vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a 0-1-6 month schedule.
On August 26, 2022, The Lancet published the findings of this Phase 3 clinical trial.
The E coli-produced HPV 16 and 18 vaccine was well tolerated and highly efficacious against HPV 16 and 18 associated high-grade genital lesions and persistent infection and would supplement the global HPV vaccine availability and accessibility for cervical cancer prevention.