BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects

BlueSky Immunotherapies GmbH25 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Safety Issues HPV Infection

Interventions

Observation without interventionOTHER

This study is a follow-up study without intervention.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Vienna

Vienna, Austria

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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