Clinical trial · Interventional
Phase 1 Dose-escalation Study of FluBHPVE6E7 in 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
| HPV-Related Cervical Carcinoma | Human Papillomavirus-Related Cervical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FluBHPVE6E7 | Biological | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FluBHPVE6E7
- description
- intracervical and intramuscular 0.5 ml per dose 3 doses (12 weeks)
- interventionNames
- Biological: FluBHPVE6E7
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- intracervical and intramuscular 0.5 ml per dose 3 doses (12 weeks)
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Frequency and severity of adverse events (AEs)
- timeFrame
- 7 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available