RecruitingPhase 1NCT05829629

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


Sponsor

BlueSky Immunotherapies GmbH

Enrollment

20 participants

Start Date

Sep 12, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the safety and dosing of a new vaccine called FluBHPVE6E7, which is designed to clear a persistent HPV16 infection (one of the strains of the human papillomavirus most likely to cause cervical cancer) in women who have low-grade or no cellular changes in the cervix. **You may be eligible if...** - You are a woman between 18 and 49 years old - You have tested positive for HPV16 on at least two separate tests (at least 3 months apart) - Your cervical cell check shows normal, borderline, or low-grade changes (not high-grade) - You have had a satisfactory colposcopy (internal cervical exam) - Your blood test and ECG results are within normal limits - You are using reliable contraception - You are not pregnant **You may NOT be eligible if...** - You have current high-grade cervical changes (CIN2/3) or have had cervical, vulvar, or vaginal cancer - You have HIV, active hepatitis B or C, or other immune deficiency - You have had any vaccine in the past 6 weeks - You are currently pregnant or breastfeeding - You have had a flu-like illness within the past 3 months - You have an active vaginal or cervical infection - You have a known allergy to oseltamivir (Tamiflu) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFluBHPVE6E7

Intracervical administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule

DRUGPlacebo

Intracervical administration for first dose followed by intramuscular administration for subsequent doses at determined schedule


Locations(1)

Univerzitná nemocnica Bratislava

Bratislava, Slovakia

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NCT05829629


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