title: Prospective study of the safety and efficacy of a pancreatic cancer stem cell vaccine.
abstract: BACKGROUND
  In this trial, we isolated and cultured pancreatic cancer stem cells (CSCs) to produce a vaccine and prospectively evaluated its safety and efficacy in low-, medium-, and high-dose groups.
  
  
  METHODS
  Between February and October 2014, we enrolled 90 patients who met the enrollment criteria and assigned them to three groups (n = 30). CSC-specific and CSC-non-specific immunity pre- and post-vaccination were compared by Dunnett's multiple comparison test (one-way ANOVA). The data are presented as the mean±standard deviation. Local and systemic adverse events were recorded in the nursing records and compared using the Chi-square test. All statistical analyses were conducted using GraphPad software (GraphPad, San Diego, CA, USA).
  
  
  RESULTS
  Throughout the trial, an injection site reaction was the most common reaction (54 %), and fever was least common (9 %). The incidence of these side effects did not vary among the three groups. When the pre- and post-vaccination immunity was compared, we found that both CSC-nonspecific and CSC-specific responses were significantly increased in the high-dose group.
  
  
  CONCLUSIONS
  This study is the first clinical trial of a pancreatic CSC vaccine and preliminarily proves its safety and efficacy.
authors: Fuda Cancer Hospital, Jinan University School of Medicine, Guangzhou, 510665, China.
authors: Mao
authors: M
authors: Lin
authors: Yuan-Ying
authors: YY
authors: Yuan
authors: Shu-Peng
authors: SP
authors: Liu
authors: Juan-Juan
authors: JJ
authors: Shi
authors: Xin-An
authors: XA
authors: Long
authors: Li-Zhi
authors: LZ
authors: Niu
authors: Ji-Bing
authors: JB
authors: Chen
authors: Qiao
authors: Q
authors: Li
authors: Ke-Cheng
authors: KC
authors: Xu
mesh_terms: D005260:Female; D006801:Humans; D007109:Immunity / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D014411:Neoplastic Stem Cells / Q000276:immunology*; D010190:Pancreatic Neoplasms / Q000276:immunology*; D011446:Prospective Studies; D012449:Safety; D014611:Vaccination / Q000379:methods; D014612:Vaccines / Q000276:immunology*
chemical_list: D014612:Vaccines