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

NCT05829629 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-14

No results posted yet for this study

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).

Conditions

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

Sponsors & Collaborators

  • BlueSky Immunotherapies GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2025-09-30
Completion
2025-11-30

Countries

  • Slovakia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05829629 on ClinicalTrials.gov