Phase I pBI-11 HPV16/18 DNA vaccine ± TA-HPV immunotherapy in advanced disease

Johns Hopkins (SKCCC) randomizes adjuvant PVX7 regimens using pBI-11 (therapeutic DNA vaccine to HPV16/18 from Papivax) via scarification or IM, with/without TA-HPV. After chemo/IO for recurrent/metastatic disease, durable options are thin; therapeutic vaccination here aims to consolidate remission and amplify HPV-specific T cells. Feasibility, safety, and immunogenicity (e.g., ELISPOT/ICS) will guide whether this platform is worth pairing with standard systemic therapy earlier.