Skip to main content
OpenTrials
Completed

NCT Number: NCT04528407

BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Safety Issues Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases HPV Infection Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observation without intervention

Other

This study is a follow-up study without intervention.

Primary outcomes

  1. Number of participants with adverse events (type, frequency, severity).

    Time frame: 1 year

    To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs

Secondary outcomes

  1. Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration

    Time frame: 1 year

    To evaluate of the induction of systemic vector-specific antibodies by HAI assay

  2. Induction of HPV-specific T-cell response following FluBHPVE6E7 administration

    Time frame: 1 year

    To evaluate the induction of HPV16 E6- and E7-specific T-cells (percent %) by IFN-gamma ELISPOT analysis

  3. Induction of HPV-specific CD4+ and CD8+ T-cells following FluBHPVE6E7 administration

    Time frame: 1 year

    To evaluate the induction of HPV16 E6- and E7 specific T-cells (percent %) by ICS and FACS analysis

  4. Local HPV clearance

    Time frame: 1 year

    To evaluate the status of HPV-16 infection by HPV test (yes or no)

  5. Cervical cytology

    Time frame: 1 year

    To evaluate changes in cervical cytology by Pap smear. Results are reported as Pap results according to the Bethesda System

  6. Biodistribution: Detection of FluBHPVE6E7 in blood samples

    Time frame: 1 year

    To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in blood samples by RT-qPCR (copies per ml blood)

  7. Biodistribution: Detection of FluBHPVE6E7 in nasal secretions

    Time frame: 1 year

    To evaluate the presence of FluBHPVE6E7 by qualitative real-time PCR assay specific for influenza B virus (positive or negative)

Sponsors and collaborators

Lead sponsor

BlueSky Immunotherapies GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2020
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.