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).
Single group
RG002 injection
Biological/VaccineIn Part A, there are three dose cohorts that are 25µg,75µg and 150µg. In Part B, there will 1 or 2 dose levels according to the results of Part A. All subjects will receive a total of three RG002 Injections, administered intramuscularly at assigned dose level, with a dosing frequency of every 2 weeks (D1, D15, and D29).
Part A: Safety and Tolerability of RG002 Injection, measured by the incidence of adverse events
Safety and Tolerability of RG002 Injection will be measured by the incidence of adverse events per CTCAE v5.0
Part A: Maximum tolerated dose (MTD) and/or RP2D of RG002 Injection
Part B: Primary efficacy of RG002 Injection, measured by the proportion of subjects with histopathological regression
The proportion of subjects with histopathological regression to either CIN1 or normal at Week 36
Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression
The proportion of subjects with histopathological regression to either CIN1 or normal at Week 36
Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with clearance of HPV16/18
The clearance of HPV16 or HPV18 will be evaluated according to the results of HPV test at Week 21 and Week 36.
Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression and clearance of HPV16/18
The proportion of subjects with histopathological regression to CIN1 or normal and clearance of HPV16 or HPV18, or both at Week36.
Part A and B: Immunogenicity of RG002 Injection,measured by the level of cellular immune response
The level of cellular immune response in Peripheral blood mononuclear cells (PBMCs) as measured by IFN-γ enzyme-linked immunosorbent spot-forming (ELISpot) assay
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
