HPV16 L2/E7/E6 Vaccine (TA-CIN): Thigh Injection Yields Stronger Immunity Post-Treatment

TA-CIN is a recombinant HPV16 L2/E7/E6 fusion-protein therapeutic vaccine; in a randomized pilot (NCT02405221), 15 HPV16+ cervical cancer patients with no evidence of disease after primary therapy (stage IB1–IVA) received three monthly 100 μg IM doses in the thigh vs arm. Thigh vaccination produced higher TA-CIN–specific antibody titers and more expanded/de novo CD8+ TCR clones (with MAIT/CD8 expansion by scRNAseq) versus arm; all treatment-related AEs were grade 1 injection-site events, and no recurrences were observed over 2 years. There is no approved adjuvant therapy after curative-intent treatment—SOC is surveillance—while pembrolizumab is now given with CRT for FIGO III–IVA but not as adjuvant in NED patients, so these immunologic gains lack a direct SOC comparator and need efficacy-powered confirmation.