Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorBlueSky Immunotherapies GmbH
About this trial
BS-02 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study to assess the safety, tolerability and immunogenicity of FluBHPVE6E7, in women infected with HPV-16. with cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1).
Eligibility criteria
Qualifiers
Females, 18-49 years of age with HPV16 infection and cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1)
HPV16 infection has been confirmed at least twice by a validated HPV test separated by at least 3 months
Satisfactory colposcopy
No clinically significant out of range haematological, renal or hepatic laboratory tests
Disqualifiers
Any vaccination within 6 weeks of day 0
Active significant viral infections including influenza, CMV, and EBV within 30 days of receiving study treatment
Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states
Current Bacterial Vaginosis (BV) infection
Trial design
Treatments tested in this trial
- FluBHPVE6E7
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov