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@ARTICLE{Dull:291649,
      author       = {P. M. Dull and S. L. Achilles and R. Ahmed and R. V.
                      Barnabas and N. G. Campos and K. Chirgwin and J. A. Cohen
                      and S. de Sanjosé and J. Doorbar and M. H. Einstein and C.
                      I. Emerson and S. L. Gottlieb and A. Hildesheim and Y. Qiao
                      and P. Ruff and J. N. Sampson and P. Sasieni and M.
                      Schiffman and H. Shin and M. A. Stanley and C. L. Trimble
                      and N. Wentzensen and A. Riemer$^*$ and J. T. Schiller and
                      A. R. Kreimer},
      title        = {{M}eeting report: {C}onsiderations for trial design and
                      endpoints in licensing therapeutic {HPV}16/18 vaccines to
                      prevent cervical cancer.},
      journal      = {Vaccine},
      volume       = {42},
      number       = {25},
      issn         = {0264-410X},
      address      = {Amsterdam},
      publisher    = {Elsevier},
      reportid     = {DKFZ-2024-01473},
      pages        = {126100},
      year         = {2024},
      note         = {2024 Nov 14;42(25):126100 / Conference report / #LA:D410#},
      abstract     = {Cervical cancer is a major cause of morbidity and mortality
                      globally with a disproportionate impact on women in low- and
                      middle-income countries. In 2021, the World Health
                      Organization (WHO) called for increased vaccination,
                      screening, and treatment to eliminate cervical cancer.
                      However, even with widespread rollout of human
                      papillomavirus (HPV) prophylactic vaccines, millions of
                      women who previously acquired HPV infections will remain at
                      risk for progression to cancer for decades to come. The
                      development and licensing of an affordable, accessible
                      therapeutic HPV vaccine, designed to clear or control
                      carcinogenic HPV and/or to induce regression precancer could
                      significantly contribute to the elimination efforts,
                      particularly benefiting those who missed out on the
                      prophylactic vaccine. One barrier to development of such
                      vaccines is clarity around the regulatory pathway for
                      licensure. In Washington, D.C. on September 12-13, 2023, a
                      meeting was convened to provide input and guidance on trial
                      design with associated ethical and regulatory
                      considerations. This report summarizes the discussion and
                      conclusions from the meeting. Expert presentation topics
                      included the current state of research, potential regulatory
                      challenges, WHO preferred product characteristics, modeling
                      results of impact of vaccine implementation, epidemiology
                      and natural history of HPV infection, immune responses
                      related to viral clearance and/or precancer regression
                      including potential biomarkers, and ethical considerations.
                      Panel discussions were held to explore specific trial design
                      recommendations to support the licensure process for two
                      vaccine indications: (1) treatment of prevalent HPV
                      infection or (2) treatment of cervical precancers.
                      Discussion covered inclusion/exclusion criteria, study
                      endpoints, sample size and power, safety, study length, and
                      additional data needed, which are reported here. Further
                      research of HPV natural history is needed to address
                      identified gaps in regulatory guidance, especially for
                      therapeutic vaccines intended to treat existing HPV
                      infections.},
      keywords     = {Cervical cancer (Other) / HPV (Other) / HPV therapeutic
                      vaccine (Other) / Human papillomavirus (Other)},
      cin          = {D410},
      ddc          = {610},
      cid          = {I:(DE-He78)D410-20160331},
      pnm          = {314 - Immunologie und Krebs (POF4-314)},
      pid          = {G:(DE-HGF)POF4-314},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:39004526},
      doi          = {10.1016/j.vaccine.2024.07.001},
      url          = {https://inrepo02.dkfz.de/record/291649},
}