Testing a new treatment for HPV16-infected women
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
This study is testing a new treatment for women aged 18-49 who are infected with HPV16 to see if it can help their immune system fight the virus and improve cervical health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | BlueSky Immunotherapies GmbH Industry-sponsored |
| Locations | 1 site (Bratislava) |
| Trial ID | NCT05829629 on ClinicalTrials.gov |
What this trial studies
This phase 1 dose-escalation study evaluates the safety, tolerability, and immunogenicity of FluBHPVE6E7, an immunotherapeutic agent designed to target HPV infections and related cervical conditions. The study involves administering FluBHPVE6E7 three times at two different dose levels, with the first dose given directly into the cervix and subsequent doses administered intramuscularly. Participants will be women aged 18-49 who are infected with HPV16 and have specific cervical cytological evaluations indicating low-grade abnormalities or no malignancy.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-49 with confirmed HPV16 infection and specific cervical cytological evaluations indicating low-grade abnormalities.
Not a fit: Patients with significant viral infections or those who have received vaccinations within the specified timeframe may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel immunotherapy option for women with HPV16 infections, potentially reducing the risk of cervical cancer.
How similar studies have performed: While this approach is novel, similar immunotherapeutic strategies have shown promise in other studies targeting HPV-related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Bratislava
- Univerzitná nemocnica Bratislava — Bratislava, Slovakia (Recruiting)
Study contacts
- Study coordinator: BlueSky Clinical Operations
- Email: clinical@bluesky-itx.com
- Phone: +43 664 1888028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.