NWRD09 for HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer
Trial Parameters
Brief Summary
This is a single-arm, open label, two cohorts, multi-center clinical study to evaluate the safety and efficacy of HPV-16 targeted mRNA vaccine (NWRD09) in HPV-16 related Cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL and HSIL) patients (cohort A) and HPV-16 related cervical cancer patients (cohort B).
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for cohort A: Patients had to meet all of the following inclusion criteria: 1. Women aged between 18 and 60 years. 2. HPV16 is positive during the screening period. 3. Histologically confirmed HPV-16-associated cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL and HSIL). In the case of LSIL, it is necessary to meet persistent HPV16 infection for more than 6 months. In the case of HSIL, it is necessary to meet the requirements of satisfactory colposcopy at screening, which is defined as the squamous columnar epithelial junction (class I or class II transformation zone) is fully visible, and the upper limit of the white epithelium acetate or suspected CIN lesions are fully visible. 4. Eligible subjects of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence, etc.) with their partner for the duration of the trial or for at least 6 months after the last dose. For premenopausa