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RECRUITING
NCT05829629
PHASE1

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

Sponsor: BlueSky Immunotherapies GmbH

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-09-12

Completion Date

2025-11

Last Updated

2025-02-14

Healthy Volunteers

No

Interventions

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

Locations (1)

Univerzitná nemocnica Bratislava

Bratislava, Slovakia