Initial preclinical safety of non-replicating human endogenous retrovirus envelope protein-coated baculovirus vector-based vaccines against human papillomavirus

Su Eun Han, Mi Gyeong Kim, Soondong Lee, Hee Jeong Cho, Youngro Byun, Sujeong Kim, Young Bong Kim, Yongseok Choi, Yu Kyoung Oh

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Human endogenous retrovirus (HERV) envelope protein-coated, baculovirus vector-based HPV 16L1 (AcHERV-HPV16L1) is a non-replicating recombinant baculoviral vaccine. Here, we report an initial evaluation of the preclinical safety of AcHERV-HPV16L1 vaccine. In an acute toxicity study, a single administration of AcHERV-HPV16L1 DNA vaccine given intramuscularly (i.m.) to mice at a dose of 1×108 plaque-forming units (PFU) did not cause significant changes in body weight compared with vehicle-treated controls. It did cause a brief increase in the weights of some organs on day 15 post-treatment, but by day 30, all organ weights were not significantly different from those in the vehicle-treated control group. No hematological changes were observed on day 30 post-treatment. In a range-finding toxicity study with three doses of 1×107, 2×107 and 5×107 PFU once daily for 5days, the group treated with 5×107 PFU showed a transient decrease in the body weights from day 5 to day 15 post-treatment, but recovery to the levels similar to those in the vehicle-treated control group by post-treatment day 20. Organ weights were slightly higher for lymph nodes, spleen, thymus and liver after repeated dosing with 5×107 PFU on day 15, but had normalized by day 30. Moreover, repeated administration of AcHERV-HPV16L1 did not induce myosin-specific autoantibody in serum, and did not cause immune complex deposition or tissue damage at injection sites. Taken together, these results provide preliminary evidence of the preclinical safety of AcHERV-based HPV16L1 DNA vaccines in mice.

Original languageEnglish
Pages (from-to)1474-1483
Number of pages10
JournalJournal of Applied Toxicology
Issue number12
Publication statusPublished - 2013 Dec 1



  • Acute toxicity
  • Baculoviral vector
  • DNA vaccine
  • Human papillomavirus
  • Sub-chronic toxicity

ASJC Scopus subject areas

  • Toxicology

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