An observational study in Safety Issues and HPV Infection, sponsored by BlueSky Immunotherapies GmbH. Completed at 1 site in Austria. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by BlueSky Immunotherapies GmbH · Observational
This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies.
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.
505 studies on the registry are indexed under Papillomavirus Infections; 128 are open to participants now.
This study's enrollment of 25 is below the median of 400 across 151 observational studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →BlueSky Immunotherapies GmbH is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This study is a follow-up study without intervention.
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
Time frame: 1 year
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration
To evaluate of the induction of systemic vector-specific antibodies by HAI assay
Time frame: 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
Time frame: 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
Time frame: 1 year
Local HPV clearance
To evaluate the status of HPV-16 infection by HPV test (yes or no)
Time frame: 1 year
Cervical cytology
To evaluate changes in cervical cytology by Pap smear. Results are reported as Pap results according to the Bethesda System
Time frame: 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)
Time frame: 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)
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Jan 2025, 45 months.
Of 69 observational studies under Papillomavirus Infections, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 90. This study's 45 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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BlueSky Immunotherapies GmbH