NCT05829629

Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women

Randomised, Double-blind, Placebo-controlled Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women with NILM, ASC-US, LSIL or Low-grade CIN

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: BlueSky Immunotherapies GmbH · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

BS-02 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study to assess the safety, tolerability and immunogenicity of FluBHPVE6E7, in women infected with HPV-16. with cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1).

Detailed description

FluBHPVE6E7 is an influenza virus vector that was modified on several levels to be used as an immunotherapeutic agent against human papillomavirus (HPV) infections, and precancers and cancers induced by HPV. Study BS-02 investigates the safety, tolerability and immunogenicity of FluBHPVE6E7 in HPV-16 infected women. FluBHPVE6E7 is administered three times at two dose levels. The first dose is administered into the cervix, subsequent doses are administered intramuscularly.

Conditions

• HPV Infection
• HPV-Related Cervical Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	FluBHPVE6E7	Intracervical administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule
DRUG	Placebo	Intracervical administration for first dose followed by intramuscular administration for subsequent doses at determined schedule

Timeline

• Start date: 2023-09-12
• Primary completion: 2025-09-01
• Completion: 2025-11-01
• First posted: 2023-04-26
• Last updated: 2025-02-14

Locations

1 site across 1 country: Slovakia