HPV Infection, Safety Issues
Conditions
Brief summary
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.
Interventions
This study is a follow-up study without intervention.
Sponsors
BlueSky Immunotherapies GmbH
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (type, frequency, severity). | 1 year | To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local HPV clearance | 1 year | To evaluate the status of HPV-16 infection by HPV test (yes or no) |
| Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration | 1 year | To evaluate of the induction of systemic vector-specific antibodies by HAI assay |
| Induction of HPV-specific T-cell response following FluBHPVE6E7 administration | 1 year | To evaluate the induction of HPV16 E6- and E7-specific T-cells (percent %) by IFN-gamma ELISPOT analysis |
| Cervical cytology | 1 year | To evaluate changes in cervical cytology by Pap smear. Results are reported as Pap results according to the Bethesda System |
| Biodistribution: Detection of FluBHPVE6E7 in blood samples | 1 year | To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in blood samples by RT-qPCR (copies per ml blood) |
| Biodistribution: Detection of FluBHPVE6E7 in nasal secretions | 1 year | To evaluate the presence of FluBHPVE6E7 by qualitative real-time PCR assay specific for influenza B virus (positive or negative) |
| Induction of HPV-specific CD4+ and CD8+ T-cells following FluBHPVE6E7 administration | 1 year | To evaluate the induction of HPV16 E6- and E7 specific T-cells (percent %) by ICS and FACS analysis |
Countries
Austria
Outcome results
None listed