BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects

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

Detailed Description
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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.

Official Title
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Follow-up Study for Patients Having Received FluBHPVE6E7 in Clinical Studies

Conditions
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Safety Issues, HPV Infection

Intervention / Treatment
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* Other: Observation without intervention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observation without intervention|This study is a follow-up study without intervention.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |