NWRD09 for HPV-16 Positive and HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer Patients.
NCT06741150 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-12-18
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 positive and HPV-16 related cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL and HSIL) patients (cohort A) and HPV-16 related cervical cancer patients (cohort B).
Conditions
- Intraepithelial Neoplasia
- Cervical Cancer
Interventions
- BIOLOGICAL
-
NWRD09 administered by intramuscular injection
Intramuscular injection administration was carried out according to the protocol design.
Sponsors & Collaborators
-
Newish Technology (Beijing) Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-24
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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