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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation without intervention | Other | This study is a follow-up study without intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration | To evaluate of the induction of systemic vector-specific antibodies by HAI assay | 1 year |
| Induction of HPV-specific T-cell response following FluBHPVE6E7 administration |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vienna | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019370 | Observation |
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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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
To evaluate the induction of HPV16 E6- and E7-specific T-cells (percent %) by IFN-gamma ELISPOT analysis |
| 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 | 1 year |
| Local HPV clearance | To evaluate the status of HPV-16 infection by HPV test (yes or no) | 1 year |
| Cervical cytology | To evaluate changes in cervical cytology by Pap smear. Results are reported as Pap results according to the Bethesda System | 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) | 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) | 1 year |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |