Clinical trial · Observational
BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects
Follow-up Study for Patients Having Received FluBHPVE6E7 in Clinical Studies
NCT04528407CI-TRIAL-00085981completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
| Safety Issues | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation without intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of participants with adverse events (type, frequency, severity).
- timeFrame
- 1 year
- description
- To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs
Secondary outcomes (7)
- measure
- Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration
- timeFrame
- 1 year
- description
- To evaluate of the induction of systemic vector-specific antibodies by HAI assay
- measure
- Induction of HPV-specific T-cell response following FluBHPVE6E7 administration
- timeFrame
- 1 year
- description
- To evaluate the induction of HPV16 E6- and E7-specific T-cells (percent %) by IFN-gamma ELISPOT analysis
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.