title: Sub-acute toxicity study in female ICR mice following repetitive intramuscular injection of cervical cancer vaccines.
abstract: OBJECTIVE
  The sub-acute toxic effects following repetitive intramuscular injection of two cervical cancer vaccines newly developed against human papillomaviruse (HPV)16/58/18 and HPV16 were investigated in female ICR (CrljOri: CD1) mice, and the no-observedadverse- effect-level (NOAEL) of the cervical cancer vaccines was estimated.
  
  
  METHODS
  Female ICR mice (n=15 in each group) were exposed to a 1:1 mixture of two cervical cancer vaccines by repetitive intramuscular injection (once a week, 5 times) for 5 weeks. Mortality, body weight, organ weight, hematological/biochemical parameters, and histopathological effects were examined at different concentrations (0, 1×10(8), 5×10(8), and 2.5×10(9) copies/animal) of the cervical cancer vaccines.
  
  
  RESULTS
  The cervical cancer vaccines did not show toxic responses for body weight, absolute/ relative organ weight, hematological/biochemical parameters, or histopathological parameters.
  
  
  CONCLUSIONS
  Female ICR mice exposed to vaccines for cervical cancer did not show any toxic response. We suggest that a NOAEL of the vaccine following repetitive intramuscular injection for 5 weeks is >2.5×10(9) copies/animal.
authors.affiliation: Biotoxtech Co. Ltd., Ochang Scientific Industrial Complex, Cheongju, Korea.
authors.forename: Seol-Hee
authors.initials: SH
authors.lastname: Moon
authors.affiliation: Biotoxtech Co. Ltd., Ochang Scientific Industrial Complex, Cheongju, Korea.
authors.forename: Du-Yeol
authors.initials: DY
authors.lastname: Kim
authors.affiliation: Biotoxtech Co. Ltd., Ochang Scientific Industrial Complex, Cheongju, Korea.
authors.forename: Jung-Min
authors.initials: JM
authors.lastname: Lee
authors.affiliation: Biotoxtech Co. Ltd., Ochang Scientific Industrial Complex, Cheongju, Korea.
authors.forename: Hee-Won
authors.initials: HW
authors.lastname: Park
authors.affiliation: Biotoxtech Co. Ltd., Ochang Scientific Industrial Complex, Cheongju, Korea.
authors.forename: Hye-Yeong
authors.initials: HY
authors.lastname: Lee
authors.affiliation: Biotoxtech Co. Ltd., Ochang Scientific Industrial Complex, Cheongju, Korea.
authors.forename: Yong-Hoon
authors.initials: YH
authors.lastname: Lee
authors.affiliation: Institute of Bioinnovation Research, R&D Center, Kolon Life Science Inc., Seoul, Korea.
authors.forename: Jaesung
authors.initials: J
authors.lastname: Lee
authors.affiliation: Institute of Bioinnovation Research, R&D Center, Kolon Life Science Inc., Seoul, Korea.
authors.forename: Jiwon
authors.initials: J
authors.lastname: Jung
authors.affiliation: Institute of Bioinnovation Research, R&D Center, Kolon Life Science Inc., Seoul, Korea.
authors.forename: Min-Ju
authors.initials: MJ
authors.lastname: Kim
authors.affiliation: Institute of Bioinnovation Research, R&D Center, Kolon Life Science Inc., Seoul, Korea.
authors.forename: Kyoung-Baek
authors.initials: KB
authors.lastname: Choi
authors.affiliation: College of Pharmacy, Seoul National University, Seoul, Korea.
authors.forename: Yu-Kyoung
authors.initials: YK
authors.lastname: Oh
authors.affiliation: Department of Animal Biotechnology, Konkuk University, Seoul, Korea.
authors.forename: Young-Bong
authors.initials: YB
authors.lastname: Kim
authors.affiliation: Institute of Bioinnovation Research, R&D Center, Kolon Life Science Inc., Seoul, Korea.
authors.forename: Sujeong
authors.initials: S
authors.lastname: Kim
authors.affiliation: Department of Nanofusion Technology, Hoseo University, Asan, Korea.
authors.forename: Seung Min
authors.initials: SM
authors.lastname: Oh
keywords: Cervical cancer vaccine; Female ICR mice; Repetitive intramuscular injection