Actively Recruiting
Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
Led by BlueSky Immunotherapies GmbH · Updated on 2025-02-14
20
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 49 years with confirmed HPV16 infection
- Cervical cytology showing NILM, ASC-US, LSIL, or low-grade CIN1
- HPV16 infection confirmed at least twice by a validated test with at least 3 months apart
- Satisfactory colposcopy results
- No significant abnormalities in blood, kidney, or liver lab tests
- Normal or non-significant ECG findings
- Negative pregnancy test at screening
- Agreement to use reliable contraception throughout the study
- Provides written informed consent
You will not qualify if you...
- Vaccination within 6 weeks prior to day 0
- Active significant viral infections including influenza, CMV, or EBV within 30 days before treatment
- Co-infection with hepatitis B, hepatitis C, or HIV or other immune deficiency
- Current bacterial vaginosis infection
- Current high-grade cervical intraepithelial neoplasia (CIN2/3)
- History or current malignancy, vulvar or vaginal intraepithelial neoplasia, atypical glandular cells, adenocarcinoma in situ, or suspected invasive disease
- Pregnancy or breastfeeding
- Influenza-like illness within 3 months before day 0
- Known allergy to oseltamivir or its components
- Cervical conditions interfering with evaluation including previous surgery or malformation
- Current pelvic inflammatory disease, cervicitis, or other gynecological infections
- Serious concurrent disorders or active systemic infections needing treatment
- Bleeding or clotting disorders or use of blood thinners within 2 weeks before day 0
- Proven or suspected autoimmune disease
- Immunosuppression requiring systemic or topical steroids or immunosuppressive drugs, except certain corticosteroids for airway or ear conditions
- Acute or history of genital herpes
- Major surgery within 4 weeks before day 0
- Blood product administration within 3 months before enrollment
- Significant cardiac, liver, or kidney disease or unstable medical conditions
- History or current neurological diseases including seizures
- Participation in another experimental study or use of investigational drugs within 2 months prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Univerzitná nemocnica Bratislava
Bratislava, Slovakia, 82606
Actively Recruiting
Research Team
B
BlueSky Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here