Actively Recruiting
Randomised, Double-blind, Placebo-controlled Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women with NILM, ASC-US, LSIL or Low-grade CIN
Led by BlueSky Immunotherapies GmbH · Updated on 2025-02-14
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating FluBHPVE6E7, a modified influenza virus vector, as an immunotherapy for women infected with HPV-16 who have certain low-grade cervical abnormalities or no serious lesions. This phase 1, randomized, double-blind, placebo-controlled study aims to assess the safety, tolerability, and immune response caused by FluBHPVE6E7 in this population. The study is sponsored by BlueSky Immunotherapies GmbH and focuses on women with specific cervical cytological findings including NILM, ASC-US, LSIL, or low-grade CIN1. FluBHPVE6E7 treatment involves three doses administered over 12 weeks. The first dose is given directly into the cervix, followed by two intramuscular injections at set intervals. Participants are randomized to receive either the FluBHPVE6E7 vaccine or a placebo, with both groups receiving identical injection schedules and volumes. The study uses a dose-escalation design to evaluate different dose levels safely. Participants will be monitored closely for adverse events within seven days after dosing and over a 16-week period to observe immune responses, viral shedding, and HPV clearance. Assessments include cervical cytology, blood and saliva testing for vaccine distribution, and measurement of HPV-specific T-cell responses. Safety evaluations include clinical exams, ECGs, and laboratory tests. The entire study duration for each participant is approximately 16 weeks, with ongoing safety and immunogenicity monitoring.
CONDITIONS
Brief 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
- Confirmed HPV16 infection at least twice by a validated test separated by at least 3 months
- Cervical cytology showing NILM, ASC-US, LSIL, or low-grade CIN1
- Satisfactory colposcopy
- No clinically significant abnormalities in haematological, renal, or hepatic lab tests
- Normal or clinically non-significant ECG
- Negative serum pregnancy test at screening
- Agreement to use reliable contraception during the entire study period
- Provides written informed consent
You will not qualify if you...
- Vaccination within 6 weeks before day 0
- Active significant viral infections including influenza, CMV, or EBV within 30 days before study treatment
- Co-infection with hepatitis B, hepatitis C, or HIV or other immune deficiencies
- Current bacterial vaginosis
- Current high-grade cervical intraepithelial neoplasia (CIN2/3)
- Prior or current malignancy, vulvar or vaginal intraepithelial neoplasia, atypical glandular cells, adenocarcinoma in situ, or suspicion of invasive disease
- Pregnancy or breastfeeding
- Influenza-like illness within 3 months before day 0
- Known allergy to oseltamivir or its components
- Anatomical cervical conditions interfering with full evaluation
- Current pelvic inflammatory disease, cervicitis, or gynecological infection
- Serious concomitant disorders or systemic infections requiring treatment
- Bleeding or clotting disorders, or recent use of blood thinners
- Autoimmune diseases
- Immunosuppression requiring systemic or topical steroids or immunosuppressive agents (with some exceptions)
- Acute or history of genital herpes
- Major surgery within 4 weeks before day 0
- Blood product administration within 3 months before enrollment
- Significant cardiac, hepatic, renal, neurological diseases or history of seizures
- Participation in another experimental protocol or investigational drug use within prior 2 months
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive three doses of FluBHPVE6E7 or placebo; the first dose is administered intracervically and the subsequent doses are given intramuscularly.
3 dosing visits
Duration - 4 weeks
Participants are monitored for safety, immune response, and HPV clearance after treatment.
Multiple visits during follow-up
Trial Site Locations
Total: 1 location
1
Univerzitná nemocnica Bratislava
Bratislava, Slovakia, 82606
Actively Recruiting
Research Team
B
BlueSky Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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