BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects

Completed

• Conditions: Safety Issues; HPV Infection

• Registration Number: NCT04528407
• Lead Sponsor: BlueSky Immunotherapies GmbH

Brief Summary

This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies.

Detailed Description

BS-FU01 is a follow-up study for patients treated with FluBHPVE6E7 in previous phase 1 and 2 interventional studies. The aim of the follow-up study is to assess the safety and immunogenicity of FluBHPVE6E7, changes in the HPV infection status, cervical cytology, and biodistribution after treatment with FluBHPVE6E7 in previous studies.

Study Timeline

• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-27
• Study Start: 2021-04-09
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patient who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7
• Negative pregnancy test at baseline
• Written informed consent

Exclusion Criteria

• Pregnancy, breastfeeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events (type, frequency, severity).	1 year	To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs

Secondary Outcome Measures

Name	Time	Method
Cervical cytology	1 year	To evaluate changes in cervical cytology by Pap smear. Results are reported as Pap results according to the Bethesda System
Biodistribution: Detection of FluBHPVE6E7 in blood samples	1 year	To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in blood samples by RT-qPCR (copies per ml blood)
Induction of HPV-specific T-cell response following FluBHPVE6E7 administration	1 year	To evaluate the induction of HPV16 E6- and E7-specific T-cells (percent %) by IFN-gamma ELISPOT analysis
Induction of HPV-specific CD4+ and CD8+ T-cells following FluBHPVE6E7 administration	1 year	To evaluate the induction of HPV16 E6- and E7 specific T-cells (percent %) by ICS and FACS analysis
Local HPV clearance	1 year	To evaluate the status of HPV-16 infection by HPV test (yes or no)
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration	1 year	To evaluate of the induction of systemic vector-specific antibodies by HAI assay
Biodistribution: Detection of FluBHPVE6E7 in nasal secretions	1 year	To evaluate the presence of FluBHPVE6E7 by qualitative real-time PCR assay specific for influenza B virus (positive or negative)

Trial Locations

Locations (1)

University of Vienna; 🇦🇹 Vienna, Austria