Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: HPV Infection, HPV-Related Cervical Carcinoma
In brief
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).
Key facts
- Study ID
- NCT05829629
- Run by
- BlueSky Immunotherapies GmbH
- People needed
- 20
- Starts
- 2023-09-12
- Expected to finish
- 2025-11-01
- Last updated by the study team
- 2025-02-14
Who can join
Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Normal screening ECG or screening ECG with no clinically significant findings, as judged by the investigator
- Negative serum pregnancy test at screening
- Agree to use a reliable form of contraception during the whole study period.
- Provides written informed consent
You may not qualify if…
- 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
- Current high-grade cervical intraepithelial neoplasia (CIN2/3)
- Prior history of or current malignancy, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), atypical glandular cells (AGC), adenocarcinoma in situ (AIS) or any suspicion of either micro-invasive or invasive disease
- Pregnancy, breastfeeding
- Influenza-like illness (ILI) within 3 months of day 0
- Known hypersensitivity to oseltamivir or any of its components
- Any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the cervix
- Current pelvic inflammatory disease, cervicitis, or other gynaecological infection as per colposcopy and clinical examination
- Serious, concomitant disorder, including active systemic infection requiring treatment
- Presence of acute or chronic bleeding or clotting disorder, or use of blood thinners within 2 weeks of day 0
- A proven or suspected autoimmune disease
- Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids, or the use of immunosuppressive agents, disease modifying doses of anti-rheumatic drugs, and biologic disease modifying drugs. Any immunosuppressive agents containing corticosteroids or monoclonal antibodies specific for the treatment of obstructive airway, ear or vestibular diseases are permissible.
- Acute or history of Herpes genitalis
- Prior major surgery within 4 weeks of day 0
- Administration of any blood product within 3 months of enrolment
- Any current significant cardiac, hepatic or renal disease or history of clinically significant, medically unstable disease
- Any current or history of neurological disease including history of seizures
- Participation in another experimental protocol/use of investigational drug during the prior two months
Where it is running
- Univerzitná nemocnica Bratislava — Bratislava, Slovakia (enrolling)
Full record on ClinicalTrials.gov
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