NCT05829629 Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
| NCT ID | NCT05829629 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | BlueSky Immunotherapies GmbH |
| Condition | HPV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-09-12 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05829629 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 49 Years, studying HPV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05829629 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05829629 currently recruiting?
Yes, NCT05829629 is actively recruiting participants. Contact the research team at clinical@bluesky-itx.com for enrollment information.
Where is the NCT05829629 trial being conducted?
This trial is being conducted at Bratislava, Slovakia.
Who is sponsoring the NCT05829629 clinical trial?
NCT05829629 is sponsored by BlueSky Immunotherapies GmbH. The trial plans to enroll 20 participants.