eligibility_summary
Elig: HLA‑haploidentical relative of an HPV16 cancer patient, 18–70 y, BMI ≥18.5, healthy, ECOG 0–1, ECG normal, adequate labs, contraception required. Excl: prior non‑L1 HPV vaccines, recent therapy or surgery, heart disease, active infections (incl HIV/HBV/HCV), autoimmune/immunodeficiency or immunosuppressants, exfoliative/atopic skin disease (incl contacts), pregnant/breastfeeding or no contraception, close contact with <5y or pregnant, vaccine allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 donor study using a heterologous prime–boost therapeutic HPV vaccine (PVX1) to generate HPV16-specific T cells for adoptive transfer. Interventions: 1) pNGVL4a-Sig/E7(detox)/HSP70 plasmid DNA vaccine (prime). Type: DNA vaccine encoding a secreted, detoxified HPV16 E7 fused to HSP70 to enhance dendritic-cell uptake and cross-presentation, priming HPV16-specific T cells. 2) TA-HPV recombinant vaccinia virus (boost). Type: live viral vector vaccine expressing HPV E6/E7 to amplify cell-mediated immunity. Cells/pathways targeted: HPV16 tumor antigens E6/E7, dendritic cells, CD8+ cytotoxic T lymphocytes and CD4+ helper T cells via MHC I/II presentation, cross-priming, and innate PRR activation by vaccinia/HSP70. Donor lymphocytes are collected for recipients via alloBMT or CD8-depleted DLI to transfer HPV-specific immunity while reducing GVHD risk.