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Personalized and HPV cancer vaccines in head and neck squamous cell carcinoma: from concept to clinical

Daria Maria Filippini1, Christophe Le Tourneau2

  • 1Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Bologna, Italy.

Translational Oncology
|March 14, 2026
PubMed

Insights

Therapeutic vaccines show promise for head and neck squamous cell carcinoma (HNSCC) by boosting antitumor immunity. However, their efficacy is limited by the tumor microenvironment, suggesting potential in earlier disease stages.

Area of Science:

  • Oncology
  • Immunotherapy
  • Vaccinology

Background:

  • Head and neck squamous cell carcinoma (HNSCC) presents significant treatment challenges with limited survival gains from current therapies, including immune checkpoint inhibitors (ICIs).
  • Emerging therapeutic vaccine strategies, including personalized neoantigen vaccines and human papillomavirus (HPV)-targeted vaccines, aim to enhance the host's antitumor immune response against HNSCC.

Purpose of the Study:

  • To review the current landscape and potential of therapeutic vaccines in head and neck squamous cell carcinoma.
  • To evaluate the safety, immunogenicity, and early clinical signals of personalized and HPV-targeted vaccines in HNSCC.
  • To discuss the limitations and future directions for vaccine-based therapies in HNSCC treatment paradigms.

Main Methods:

  • Review of early-phase clinical trials and published data on personalized neoantigen vaccines (e.g., TG4050, mRNA-4157, PGV001) and HPV-targeted vaccines (e.g., PDS0101, BNT113, CUE-101) in HNSCC.
  • Analysis of safety profiles, immunogenicity data, and preliminary efficacy signals, particularly in the adjuvant setting and in combination with ICIs.
  • Consideration of factors influencing vaccine efficacy, such as tumor mutational landscape, HPV status, and the tumor microenvironment.

Main Results:

  • Personalized vaccines demonstrate favorable safety and immunogenicity, with early signals of activity in small studies, especially in the adjuvant setting.
  • HPV-targeted vaccines are being explored in HPV-positive HNSCC, often combined with ICIs, showing some early clinical activity.
  • Randomized trials have yielded mixed results, with some failing to demonstrate survival benefits over ICIs alone, necessitating cautious interpretation of early data due to study limitations.

Conclusions:

  • Therapeutic vaccination is generally safe and immunologically active in HNSCC but faces constraints from the immunosuppressive tumor microenvironment.
  • The optimal application of therapeutic vaccines may be in earlier stages of HNSCC, where tumor burden is lower and immune intervention is more feasible.
  • Further research is crucial to determine the best integration of vaccine therapies into multimodal treatment strategies for HNSCC.
Keywords:
HPV therapeutic vaccinesHead and neck cancerImmunotherapyPersonalized neoantigen vaccinestumor microenvironment

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