eligibility_summary
Inclusion: Adults ≥19 with persistent (>6 mo) ASC-US/LSIL or persistent HPV16+ (other HPV co-infections allowed), acceptable ECOG, adequate organ function, WOCBP use dual contraception, able to consent/comply. Exclusion: HPV16− cytology, CIN2+, immunosuppression/steroids, prior HPV vaccine, recent investigational therapy, uncontrolled illness, autoimmune disease (except thyroiditis/psoriasis/Sjögren’s/IBD), allergy to agents, pregnant/breastfeeding, HIV/HCV/HBV, prior LEEP/conization, prior malignancy unless disease-free ≥5y (resected non-melanoma skin cancer allowed).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I, dose-escalation trial in persistent HPV16+ ASC-US/LSIL tests two therapeutic vaccines: 1) pNGVL4aCRTE6E7L2, a naked DNA plasmid (biologic) delivered intramuscularly that encodes HPV16 E6/E7/L2 fused to calreticulin to enhance antigen processing/presentation, aiming to elicit strong HPV16-specific CD8+ and CD4+ T-cell responses, doses 0.3, 1, or 3 mg at weeks 0, 4, and 8. 2) TA-CIN, a protein subunit vaccine (L2–E7–E6 fusion) given as a boost after DNA priming (week 8) in a prime–boost arm. Targets/pathways: dendritic cell uptake, MHC I and II presentation (calreticulin-enhanced), cytotoxic T lymphocyte killing of HPV16 E6/E7-expressing cervical epithelial cells, plus anti-L2 humoral responses that can block viral entry. Primary goal: safety/feasibility and optimal DNA dose selection.