BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects

Safety Issues Clinical Trial

Official title:

Follow-up Study for Patients Having Received FluBHPVE6E7 in Clinical Studies

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04528407
• Other study ID #: BS-FU01
• Status: Enrolling by invitation
• Start date: April 9, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2023
• Source: BlueSky Immunotherapies GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• HPV Infection
• Papillomavirus Infections
• Safety Issues

Intervention

Other:
• Observation without intervention
This study is a follow-up study without intervention.

Locations

Country	Name	City	State
Austria	University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
BlueSky Immunotherapies GmbH

Country where clinical trial is conducted

Austria, 

Outcome

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