NCT04528407

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

April 9, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

3.8 years

First QC Date

August 20, 2020

Last Update Submit

February 11, 2025

Conditions

Safety IssuesHPV Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

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

    1 year

  • Induction of HPV-specific T-cell response following FluBHPVE6E7 administration

    1 year

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

    1 year

  • Local HPV clearance

    1 year

  • Cervical cytology

    1 year

  • +2 more secondary outcomes

Interventions

Observation without interventionOTHER

This study is a follow-up study without intervention.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Pregnancy, breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vienna

Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for determination of the immune response Nasal secretion and blood samples for biodistribution Cervical smear for cytology and HPV test Urine for Pregnancy test

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

ObservationMethods

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2020

First Posted

August 27, 2020

Study Start

April 9, 2021

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations

AU(1)