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NWRD08 in HPV16/18-Positive Cervical HSIL
NCT07175662Phase 2
Key facts
- Status
- Recruiting
- Start
- Nov 2025
- Primary completion
- May 2027
- Countries
- 1
- Sponsor
- Newish Biotechnology
- Modality
- Prophylactic Vaccines, Therapeutic Vaccines, DNA Vaccines
- Drugs
- NWRD08
- Conditions
- cervical squamous intraepithelial lesion (SIL)
01
Overview
Phase 2, randomised, double-blind trial of NWRD08 in cervical squamous intraepithelial lesion (SIL), sponsored by Newish Biotechnology. Primary endpoint: Proportion of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or no lesions at 36 weeks. Started Nov 2025; status: recruiting.
02
Design
- Study design
- RandomizedDouble-blind
03
Endpoints
Primary
Proportion of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or no lesions
Secondary
Incidence and severity of local and systemic adverse events
Incidence and severity of adverse events at the injection site
Incidence and severity of all serious adverse events
Proportion of Participants with Virologically-proven Clearance of HPV 16 and/or HPV18
Levels of cellular immune responses
Levels of serum anti-HPV16 and anti-HPV18 antibody titers
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