Abstract
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 language | English |
|---|---|
| Pages (from-to) | 1474-1483 |
| Number of pages | 10 |
| Journal | Journal of Applied Toxicology |
| Volume | 33 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - 2013 Dec 1 |
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Keywords
- Acute toxicity
- Baculoviral vector
- DNA vaccine
- Human papillomavirus
- Sub-chronic toxicity
ASJC Scopus subject areas
- Toxicology
Cite this
Initial preclinical safety of non-replicating human endogenous retrovirus envelope protein-coated baculovirus vector-based vaccines against human papillomavirus. / Han, Su Eun; Kim, Mi Gyeong; Lee, Soondong; Cho, Hee Jeong; Byun, Youngro; Kim, Sujeong; Kim, Young Bong; Choi, Yongseok; Oh, Yu Kyoung.
In: Journal of Applied Toxicology, Vol. 33, No. 12, 01.12.2013, p. 1474-1483.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Initial preclinical safety of non-replicating human endogenous retrovirus envelope protein-coated baculovirus vector-based vaccines against human papillomavirus
AU - Han, Su Eun
AU - Kim, Mi Gyeong
AU - Lee, Soondong
AU - Cho, Hee Jeong
AU - Byun, Youngro
AU - Kim, Sujeong
AU - Kim, Young Bong
AU - Choi, Yongseok
AU - Oh, Yu Kyoung
PY - 2013/12/1
Y1 - 2013/12/1
N2 - 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.
AB - 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.
KW - Acute toxicity
KW - Baculoviral vector
KW - DNA vaccine
KW - Human papillomavirus
KW - Sub-chronic toxicity
UR - http://www.scopus.com/inward/record.url?scp=84886098316&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84886098316&partnerID=8YFLogxK
U2 - 10.1002/jat.2815
DO - 10.1002/jat.2815
M3 - Article
C2 - 22987290
AN - SCOPUS:84886098316
VL - 33
SP - 1474
EP - 1483
JO - Journal of Applied Toxicology
JF - Journal of Applied Toxicology
SN - 0260-437X
IS - 12
ER -