BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects

February 20, 2023 updated by: BlueSky Immunotherapies GmbH

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year
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
1 year
Local HPV clearance
Time Frame: 1 year
To evaluate the status of HPV-16 infection by HPV test (yes or no)
1 year
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
1 year
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)
1 year
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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BlueSky Immunotherapies GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2021

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BS-FU01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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