BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects

NCT ID: NCT04528407

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-09

Study Completion Date

2025-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Safety Issues HPV Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Observation without intervention

This study is a follow-up study without intervention.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BlueSky Immunotherapies GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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BS-FU01

Identifier Type: -

Identifier Source: org_study_id

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