title: Safety and efficacy study of nasopharyngeal cancer stem cell vaccine.
abstract: In this trial, nasopharyngeal cancer stem cells (CSCs) were separated and cultured to produce a vaccine; its safety and efficacy were prospectively evaluated in low-, medium-, and high-dose groups. Between April and September 2014, we enrolled 90 patients who met the enrolment criteria, and assigned them to three groups (n=30). Throughout the trial, injection site reaction was the most common reaction (81%), and fever was least common (31%); however, there was no difference among the three groups. When the immune responses pre- and post-vaccination were compared, we found that the CSC-specific and -nonspecific response in the medium- and high-dose groups were both significantly enhanced. This study is the first clinical trial of a nasopharyngeal CSC vaccine and preliminarily proves its safety and efficacy.
authors: Fuda Cancer Hospital, Jinan University School of Medicine, Guangzhou, China.
authors: Mao
authors: M
authors: Lin
authors: Fuda Cancer Hospital, Jinan University School of Medicine, Guangzhou, China.
authors: Yuanying
authors: Y
authors: Yuan
authors: Fuda Cancer Hospital, Jinan University School of Medicine, Guangzhou, China.
authors: Jongyuan
authors: J
authors: Xu
authors: Fuda Cancer Hospital, Jinan University School of Medicine, Guangzhou, China.
authors: Xiaoling
authors: X
authors: Cai
authors: Fuda Cancer Hospital, Jinan University School of Medicine, Guangzhou, China.
authors: Shupeng
authors: S
authors: Liu
authors: Fuda Cancer Hospital, Jinan University School of Medicine, Guangzhou, China.
authors: Lizhi
authors: L
authors: Niu
authors: Fuda Cancer Hospital, Jinan University School of Medicine, Guangzhou, China. Electronic address: jibingchen398@163.com.
authors: Jibing
authors: J
authors: Chen
authors: Comprehensive Cancer Center, University of Michigan, Ann Arbor, USA. Electronic address: qiaoli@umich.edu.
authors: Qiao
authors: Q
authors: Li
authors: Fuda Cancer Hospital, Jinan University School of Medicine, Guangzhou, China.
authors: Kecheng
authors: K
authors: Xu
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers; D019496:Cancer Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D016130:Immunophenotyping; D007167:Immunotherapy; D016131:Lymphocyte Subsets / Q000276:immunology / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000276:immunology* / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D014411:Neoplastic Stem Cells / Q000276:immunology* / Q000378:metabolism; D014611:Vaccination
chemical_list: D015415:Biomarkers; D019496:Cancer Vaccines
keywords: Cancer prevention; Cancer stem cell; Efficacy; Immunotherapy; Nasopharyngeal cancer; Safety; Vaccine