eligibility_summary
Inclusion: women 18–49 with persistent HPV16 (≥2 positives ≥3 months apart) and NILM/ASC-US/LSIL/CIN1, satisfactory colposcopy, negative pregnancy test, contraception, consent. Exclusion: recent vaccines/ILI, active infections (viral/bacterial/gynecologic)/HBV/HCV/HIV, CIN2/3 or malignancy, pregnancy/breastfeeding, oseltamivir allergy, cervical anatomic issues/surgery, serious disease (cardiac/hepatic/renal/neurologic), coagulopathy/anticoagulants, autoimmune or immunosuppressed, recent trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05829629 (Phase 1, randomized, double-blind, placebo-controlled). Intervention: FluBHPVE6E7, a biological influenza virus–vector therapeutic vaccine. Mechanism: the vector is engineered to present HPV16 E6/E7 oncoprotein antigens to the immune system, aiming to induce strong HPV-specific cellular immunity (primarily CD8+ cytotoxic T cells and CD4+ helper T cells) via antigen presentation by dendritic cells, first dose intracervical, then intramuscular, 3 doses over 12 weeks, placebo comparator. Targets: HPV16-infected cervical epithelial cells expressing E6/E7. Pathways: immunologic clearance of E6/E7-expressing cells and functional counteraction of E6/E7-driven oncogenic pathways (p53 and Rb disruption). Population: HPV16+ women with NILM, ASC-US, LSIL, or CIN1. Outcome focus: safety, tolerability, immunogenicity.