Both authors contributed equally to this work.
Initial preclinical safety of non-replicating human endogenous retrovirus envelope protein-coated baculovirus vector-based vaccines against human papillomavirus
Version of Record online: 14 SEP 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Journal of Applied Toxicology
Volume 33, Issue 12, pages 1474–1483, December 2013
How to Cite
Han, S.-E., Kim, M.-G., Lee, S., Cho, H.-J., Byun, Y., Kim, S., Kim, Y. B., Choi, Y. and Oh, Y.-K. (2013), Initial preclinical safety of non-replicating human endogenous retrovirus envelope protein-coated baculovirus vector-based vaccines against human papillomavirus. J. Appl. Toxicol., 33: 1474–1483. doi: 10.1002/jat.2815
- Issue online: 22 OCT 2013
- Version of Record online: 14 SEP 2012
- Manuscript Revised: 20 JUL 2012
- Manuscript Accepted: 20 JUL 2012
- Manuscript Received: 25 JUN 2012
- human papillomavirus;
- baculoviral vector;
- acute toxicity;
- sub-chronic toxicity;
- DNA vaccine
Human endogenous retrovirus (HERV) envelope protein-coated, baculovirus vector-based HPV 16 L1 (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 5 days, 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. Copyright © 2012 John Wiley & Sons, Ltd.