Safety IssuesNCT04528407
BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects
An observational study of Safety Issues and HPV Infection, run by BlueSky Immunotherapies GmbH at 1 site in Austria.
Trial summary
This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, HPV Infection
- What is being tested?
- Observation without intervention
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- 9 Apr 2021to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7
Who may be able to join
- Patient who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7
- Negative pregnancy test at baseline
- Written informed consent
Who cannot join
- Pregnancy, breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Safety Issues, HPV Infection
- Being tested
- Observation without intervention
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation without interventionOther
This study is a follow-up study without intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (7)
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration
To evaluate of the induction of systemic vector-specific antibodies by HAI assay
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
Local HPV clearance
To evaluate the status of HPV-16 infection by HPV test (yes or no)
Measured: 1 year
Cervical cytology
To evaluate changes in cervical cytology by Pap smear. Results are reported as Pap results according to the Bethesda System
Measured: 1 year
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)
Measured: 1 year
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start9 Apr 2021
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- BlueSky Immunotherapies GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528407
- Sponsor's protocol ID
- BS-FU01
- Status last verified
- Feb 2025
- First submitted
- 20 Aug 2020
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study for Patients Having Received FluBHPVE6E7 in Clinical Studies
- ClinicalTrials.gov ID
- NCT04528407
- Acronym / sponsor ID
- BS-FU01
- Conditions
- Safety Issues, HPV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- BlueSky Immunotherapies GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7
Key inclusion criteria (3 listed)
- Patient who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7
- Negative pregnancy test at baseline
- Written informed consent
Key exclusion criteria (1 listed)
- Pregnancy, breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation without interventionThis study is a follow-up study without intervention. | Other | – |
Primary outcome
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
7 secondary outcomes
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration
Time frame: 1 year
Induction of HPV-specific T-cell response following FluBHPVE6E7 administration
Time frame: 1 year
Induction of HPV-specific CD4+ and CD8+ T-cells following FluBHPVE6E7 administration
Time frame: 1 year
Local HPV clearance
Time frame: 1 year
Cervical cytology
Time frame: 1 year
Biodistribution: Detection of FluBHPVE6E7 in blood samples
Time frame: 1 year
Biodistribution: Detection of FluBHPVE6E7 in nasal secretions
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues and HPV Infection, run by BlueSky Immunotherapies GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (type, frequency, severity). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.