title: New concepts of biomarkers and clinical outcomes for therapeutic cancer vaccines in clinical trials.
abstract: OBJECTIVE
  This study aimed to derive meaningful parameters for immune monitoring during cancer vaccine development by analysis of the literature.
  
  
  METHODS
  This retrospective study was based on analysis of clinical trials registered at ClinicalTrials.gov and published data available on PubMed.
  
  
  RESULTS
  The most common sample evaluated in immune monitoring was peripheral blood. All trials employed ELISA for detecting a humoral immune response; however, cellular immune assays were not used across trials. Most cellular immune assays failed to correlate with clinical outcome, although results of other methods did.
  
  
  CONCLUSIONS
  Standardization of the cellular immune assays across trials is important for predicting the effects of therapeutic cancer vaccines when considering the reliability and characteristics of the methods. Currently, assays mostly target detection of T-cell function, such as proliferation and cytokine release; however, T-cell phenotype analysis in peripheral blood and/or tumor sites may also be considered in the future.
authors.affiliation: Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University & Waseda University; TWIns, 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan.
authors.forename: Chizuru
authors.initials: C
authors.lastname: Ogi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Aruga
mesh_terms: D014408:Biomarkers, Tumor / Q000276:immunology*; D019496:Cancer Vaccines / Q000276:immunology*; D002986:Clinical Trials as Topic; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D008214:Lymphocytes / Q000276:immunology*; D015166:Monitoring, Immunologic / Q000379:methods* / Q000592:standards; D009369:Neoplasms / Q000276:immunology / Q000628:therapy*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D014408:Biomarkers, Tumor; D019496:Cancer Vaccines
keywords: biomarker; cancer; immune monitoring; immunotherapy; regulatory science; vaccine