A randomized double-blind placebo-controlled phase I/II clinical trial of a human papillomavirus therapeutic vaccine, PepCan, for reducing head and neck squamous cell carcinoma recurrence (IMAGE)
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Figure 1: Consort diagram and the trial design.
(A) A consort diagram summarizing patient progress during the trial. One patient in the PepCan arm was found to be “ineligible” for having had a previous recurrence. This patient was followed for safety but excluded from efficacy analysis. (B) The first 4 injections (PepCan or placebo) were given every three weeks, and the next 3 injections were given every 3 months. Patients had two follow-up visits six months apart after the final injection. Blood was collected at visits 1, 5, 8, and 9 for immunological assessments by ELISPOT, bulk TCR deep sequencing, and FACS analysis, and for cytokine analysis. Oral wash samples were collected at screening, visit 5, visit 7, and visit 8 and stool samples were collected at home after these visits for microbiome analyses.
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Copyright: © 2026 Bivens et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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