The purpose of this study is to to evaluate the safety, tolerability, immunogenicity, and efficacy of RG002 Injection in subjects with HPV16/18 associated Cervical Intraepithelial Neoplasia Grade 2 or 3(CIN2/3).
Written informed consent in accordance with study site guidelines.
Female 18~45 years of age when signing the ICF for Part A, and 18~55 years of age when signing the ICF for Part B.
Body mass index (BMI) ≤30 kg/m2.
Pathological diagnosis of CIN Grade 2 or 3 as confirmed by central pathological reviewers within 12 weeks prior to administration of first study vaccination.
Cervical adenocarcinoma in situ (AIS), or atypical endometrial or glandular cells, or evidence of invasive cervical carcinoma on cervical biopsy within 12 weeks prior to administration of first study vaccination.
High-grade intraepithelial neoplasia or invasive carcinoma of vulva, vagina or anus.
History of severe allergy to any vaccine or serious hypersensitivity reaction to a known ingredient (e.g., PEG) of RG002 injection judged by the investigator.
Active infection with herpes simplex virus (HSV).