This trial is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy and safety of SYS6026 at different doses compared to placebo in treating patients with HPV16 or 18-related high-grade cervical squamous intraepithelial lesions (HSIL).
Age must be 18 years old or above;
During the screening period, the research center confirmed participants with HPV type 16 and/or type 18 cervical infection;
During screening, the research center confirmed histological evidence of cervical HSIL (CIN grade 2~CIN3) (lesions may be obtained within 3 months prior to the first study treatment);
Colposcopy results at each research center during the screening period must meet the following conditions: 1) Fully visible squamous-columnar epithelial junction (type I or type II transformation zone), with fully visible upper white acetic acid epithelial or suspected CIN lesions; 2) Cervical lesions can be touched and sampled by biopsy instruments, and the cervical lesions are sufficiently large to ensure visible lesions remain for observation during the study period;
Screening combined with other high-risk HPV subtypes (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68);
Cases with VIN/VAIN/AIN or AIS or other lesions should be excluded.
During screening, cytological or histopathological examination yields any of the following: AIS, AGC-FN, invasive cancer, etc.;
HSIL treatment within 4 weeks prior to the first vaccination;