Study of FluBHPVE6E7 in HPV-16 Infected Women
- Conditions
- HPV Infection
- Interventions
- Biological: FluBHPVE6E7
- Registration Number
- NCT04490512
- Lead Sponsor
- BlueSky Immunotherapies GmbH
- Brief Summary
BS-01 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study assessing safety, tolerability and immunogenicity of FluBHPVE6E7, changes in the HPV infection status and cervical cytology, and biodistribution in HPV-16 infected women with normal cytology, CIN1 or CIN2. The safety and immunogenicity of two dose levels, 7.5 log10 and 9.0 log10 fTCID50/dose of FluBHPVE6E7 are assessed after three subcutaneous administrations. In addition the safety of 9.0 log10 fTCID50/dose of FluBHPVE6E7 is assessed after three intradermal or intramuscular administrations.
- Detailed Description
BS-01 is a randomised, placebo-controlled, double- blind phase 1 dose-escalation study in women with normal cytology, CIN1 or CIN2.
The primary objective is to assess the safety and tolerability of FluBHPVE6E7. Secondary objectives are the assessment of the systemic immune responses to immunisations with FluBHPVE6E7, changes in HPV infection status and cervical cytology, and biodistribution.
Study medication is administered three times (Day 0, Week 4, Week 12). Study participants are randomised at a ratio of 3:1 for FluBHPVE6E7 or placebo. The first cohort is treated subcutaneously at dose level 7.5 log10 fTCID50/dose. The second cohort is treated subcutaneously at 9.0 log10 fTCID50/dose.
Interim safety reviews are performed by a Data Monitoring Committee. After completion of the dose-escalation and in order to collect additional safety data on the highest safe and tolerated dose level, additional study participants are enrolled into expansion cohorts treated three times subcutaneously, intradermally or intramuscularly at 9.0 log10 fTCID50/dose.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FluBHPVE6E7 FluBHPVE6E7 Multiple administration of FluBHPVE6E7 Placebo FluBHPVE6E7 Multiple administration of buffer solution
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (type, frequency, severity). 7 days To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs
- Secondary Outcome Measures
Name Time Method Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration 16 weeks To evaluate of the induction of systemic vector-specific antibodies by HAI assay
Induction of HPV-specific CD4+ and CD8+ T-cells following FluBHPVE6E7 administration 16 weeks To evaluate the induction of HPV16 E6- and E7 specific T-cells (%) by ICS and FACS analysis
Cervical cytology 16 weeks To evaluate changes in cervical cytology by Pap smear. Results are reported as Pap results according to the Bethesda System
Number of participants with adverse events (type, frequency, severity). 16 weeks To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs
Local HPV clearance 16 weeks To evaluate the status of HPV-16 infection by HPV test (yes or no)
Induction of HPV-specific T-cell response following FluBHPVE6E7 administration 16 weeks To evaluate the induction of HPV16 E6- and E7-specific T-cells (%) by IFN-gamma ELISPOT analysis
Biodistribution: Detection of FluBHPVE6E7 in nasal secretions 16 weeks To evaluate the presence of FluBHPVE6E7 by qualitative real-time PCR assay specific for influenza B virus (positive or negative)
Biodistribution: Detection of FluBHPVE6E7 in blood samples 16 weeks To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in blood samples by RT-qPCR (copies per ml blood)
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria