NWRD09 for HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer
NCT07092007 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-07-29
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).
Conditions
- Intraepithelial Neoplasia
- Cervical Cancer
Interventions
- BIOLOGICAL
-
NWRD09 administered by intramuscular injection
NWRD09 administered by intramuscular injection according to the study protocol.
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
- 2024-06-05
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
More Related Trials
-
Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years
NCT00290277 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Immunogenicity Study of Human Papilloma Virus Vaccine in Women Aged 9 to 30 and Men Aged 9 to 17
NCT02888418 ·Status: UNKNOWN ·Phase: PHASE1
-
A Phase I Study of Quadrivalent HPV Recombinant Vaccine
NCT03085381 ·Status: COMPLETED ·Phase: PHASE1
-
Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (54m)
NCT04704908 ·Status: UNKNOWN
-
A Study of Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine
NCT03900572 ·Status: COMPLETED ·Phase: PHASE1
-
Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 Vaccine in Healthy Females
NCT02740790 ·Status: COMPLETED ·Phase: PHASE2
-
Phase III Study Comparing the Immunogenicity of 9-valent HPV Recombinant Vaccine and Gardasil-9
NCT05580341 ·Status: UNKNOWN ·Phase: PHASE3
-
An Immuno-bridging Study of a Nonavalent HPV Vaccine (E.Coli) in Healthy Population Aged 9-17 vs Aged 18-26 Years Old
NCT05056402 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years
NCT04895020 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China
NCT05662020 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China
NCT01427777 ·Status: UNKNOWN
-
Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
NCT04425291 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years
NCT05027776 ·Status: RECRUITING ·Phase: PHASE3
-
Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
NCT03676101 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
NCT00090220 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.
NCT02733068 ·Status: COMPLETED ·Phase: PHASE3
-
Testing RG1-VLP Vaccine to Prevent HPV-related Cancers
NCT05985681 ·Status: RECRUITING ·Phase: PHASE1
-
Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine
NCT05371353 ·Status: RECRUITING
-
Immunogenicity AND Safety Study of the 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)
NCT04436133 ·Status: COMPLETED ·Phase: PHASE2
-
The Durability of Protection and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female
NCT05045755 ·Status: UNKNOWN
-
Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants
NCT00128661 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
NCT04537156 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
NCT01356823 ·Status: COMPLETED ·Phase: PHASE2
-
Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
NCT03158220 ·Status: COMPLETED ·Phase: PHASE3
-
Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)
NCT00092521 ·Status: COMPLETED ·Phase: PHASE3