• Title/Summary/Keyword: Vaccine Safety

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Reversibility and safety of KISS1 metastasis suppressor gene vaccine in immunocastration of ram lambs

  • Han, Yan-Guo;Liu, Gui-Qiong;Jiang, Xun-Ping;Xiang, Xing-Long;Huang, Yong-Fu;Nie, Bin;Zhao, Jia-Yu;Nabeel, Ijaz;Tesema, Birhanu
    • Asian-Australasian Journal of Animal Sciences
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    • v.31 no.6
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    • pp.835-841
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    • 2018
  • Objective: The aim of this study was to investigate the reversibility and safety of KISS1 metastasis suppressor (KISS1) gene vaccine in immunocastration. Methods: Six eight-week old ram lambs were randomly divided into vaccinated and control groups. The vaccine (1 mg/ram lamb) was injected at weeks 0, 3, and 6 of the study. Blood samples were collected from the jugular vein before primary immunization and at weeks 2, 4, 6, 10, 14, 22, and 30 after primary immunization. All ram lambs were slaughtered at 38 weeks of age, and samples were collected. Results: The specific anti-KISS1 antibody titers in vaccinated animals were significantly higher and the serum testosterone level was significantly lower than those in the control groups from week 4 to 14 after primary immunization (p<0.05). No significant difference was observed at weeks 22 and 30 after the primary immunization. Similar results were also found for scrotal circumference, testicular weight, length, breadth, and spermatogenesis in seminiferous tubules in week 30 after primary immunization. KS (KISS1-hepatitis B surface antigen S) fusion fragment of KISS1 gene vaccine was not detected in host cell genomic DNA of 9 tissues of the vaccinated ram lambs by polymerase chain reaction. Conclusion: The effects of KISS1 gene vaccine in immunocastration were reversible and no integration events were recorded.

Evaluation on Immunogenicity and Safety of Avian Influenza Isolate(ADL0401) as a Candidate for the Killed Vaccine against tow-Pathogenic Avian Influenza (약병원성 조류인플루엔자 사독백신개발을 위한 후보주(ADL0401)의 면역 원성 및 안전성 평가)

  • Lee J. S.;Ha D. H.;Kim J. E.;Ha B. D.;Mo I. P.
    • Korean Journal of Poultry Science
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    • v.32 no.2
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    • pp.113-123
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    • 2005
  • Avian influenza (AI) virus (AIV) is distributed worldwide and it has been isolated from various species of wild and domestic birds. AI transfers with high speed and shows diverse pathogenicity syndroms. In Korea, several low Pathogenic AIV, H9N2, have been isolated from the commercial farms with severe decrease of egg production and mortality resulted in severe economic loss since 1996. Therefore, it has been requested to develop AI vaccines to prevent clinical signs and economic losses from the field infection of AIV. To develop a killed vaccine that efficiently prevents low pathogenic AIV (H9N2), evaluation on the pathogenicity and selection of an inactivator for H9N2 is taking place and is being tested safety and immunogenicity of vaccine produced. Based on the pathogenicity test and viral reisolation test, the ADL0401 isolate is the characteristic low pathogenic AIVs and has fairly similar biologic functions compared with MS96 which is the official low pathogenic AIV (H9N2) and one of the predominant AIV isolated from poultry farms in Korea. In antigenicity tests, the ADL0401 and MS96 virus have no significant antigenic difference. In inactivation tests, the ADL0401 isolates can be easily inactivated with $0.1\%$ Formalin at $37^{\circ}C$ within 1 hour with a little decrease of HA titer. The vaccine developed in the present report has no harmful effect on bird and forms good immune capability. Therefore, the isolates, ADL0401 can be used for a killed vaccine which can reduce the clinical signs and viral shedding in the birds infected with H9N2 low pathogenic AIVs.

Immunogenicity and Safety of Recombinant Hepatitis B Vaccine(HG-IIR) in Healthy Infants and Children (유전자 재조합 B형간염 백신의 10세이하 소아에서의 면역원성 및 안전성)

  • Kim, Myoung Ah;Choi, Eun Ha;Jang, Mee Suk;Dong, Eun Sil;Jang, Seong Hee;Ahn, Young Min;Youn, Hee Sang;Sohn, Young Mo
    • Pediatric Infection and Vaccine
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    • v.4 no.1
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    • pp.106-115
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    • 1997
  • Objective : To evaluate the immunogenicity and safety afforded by the HG-II$^{(R)}$ recombinant hepatitis B vaccine given to healthy neonates and children and to find the influence of preceding BCG vaccination on immunogenicity. Methods : Three doses of recombinant hepatitis B vaccine with a dose of $10{\mu}g$ were given at birth, 1 and 6 months of age. This study was conducted in three hospitals (Gyeongsang National University Hospital(Group A), Kangnam General Hospital(Group B) and Younsei University Hospital(Group C)) from April, 1995 to June, 1996. Group A and Group B received 2nd dose of hepatitis B vaccine at 1 week after and before BCG vaccine, respectively. Antibidy levels, at 1 month after the 3rd dose of hepatitis B vaccine were determined by a radioimmunoassay. Results : 1) One hundred four infants and ten children were enrolled : 55 infants and 43 infants received 2nd dose of hepatitis B vaccine at 1 week after( After BCG Group) and before BCG vaccine(Before BCG Group), respectively. 2) The seropositive rate was 99.1%, and geometric mean anti-HBs titer was 131.2mIU/ml. 3) The geometric mean titers were 105.5mIU/ml and 162.8mIU/ml in After BCG and Before BCG Group, respectively(p<0.025). 4) Among 359 episodes of vaccination, the occurrence of systemic and local side reaction were reported in 7.8% and 1.4%, respectively. Conclusion : Recombinant hepatitis B vaccine(HG-II$^{(R)}$))was highly immunogenic and safe. The significantly lower geometric mean antibody titer in the BCG preceding group was observed. Well-designed controlled study with the large number of sample size will be required to show the influence of preceding BCG vaccination.

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The immunogenicity and safety of three-component DTaP vaccine in Korean infants (우리나라 영아에서 3가 정제 백일해 항원 DTaP 백신의 면역원성 및 안전성)

  • Kang, Jin Han;Kim, Jong Hyun;Lee, Jung Hyun;Lee, Soo Young;Hong, Young Jin;Kim, Chang Hwi
    • Clinical and Experimental Pediatrics
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    • v.50 no.4
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    • pp.355-362
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    • 2007
  • Purpose : We conducted the study to evaluate the immunogenicity and safety of three component DTaP vaccine ($Infanrix^{(R)}$) in a group of Korean healthy infants on a three-dose primary vaccination. And we compared the immunogenicity of this DTaP vaccine with two component DTaP vaccine which has been widely used in Korea. Methods : We enrolled one hundred fifty one healthy infants aged 8-9 weeks. These infants were vaccinated at age 2, 4 and 6 months of age with three component DTaP vaccine. Solicited adverse events were actively monitored for 72 hours following each vaccination, and all adverse events after each vaccination were observed for three weeks. Anti-diphtheria toxoid Ab., anti-tetanus toxoid Ab., anti-pertussis toxin Ab., anti-filamentous hemagglutinin Ab., and anti-pertactin Ab. were measured using ELISA for assessing immunogenicity of study vaccine in 60 infants. Immunogenicity analysis of two component DTaP vaccine was performed with same methods in 14 infants as control. Results : The seroconversion rates of anti-diphtheria toxoid Ab, anti-tetanus toxoid Ab. anti-filamentous hemagglutinin Ab. were 100% in both group. Seroconversion rate of anti-pertactin Ab in study group was 100%, but the rate in control group was 50%. However, geometric mean concentration of anti-pertussis toxin Ab. was higher in control group. Mild local and systemic reactions were observed within three days after vaccination, and no serious adverse events related study vaccine were happened during study period. Conclusion : Our study results suggest that three component DTaP vaccine ($Infanrix^{(R)}$) is a well-tolerable and high immunogenic vaccine, especially anti-Pertactin Ab. of the study vaccine is very immunogenic. It can be available as routine DTaP vaccination in our infants.

Design and Implementation of Safety Verification System for Application Software (응용 소프트웨어 안전성 검증 시스템 설계 및 구현)

  • Soh, Woo-Young
    • Convergence Security Journal
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    • v.8 no.4
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    • pp.191-197
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    • 2008
  • A safe computer environment is necessarily required for computer users, because of a damage is widely increased by a malicious software such as the warm, virus and trojan horse. A general vaccine program can detect after the malicious software intruded. This kinds of the vaccine program show good result against a malicious code which is well known, however, there is no function in the vaccine or not enough ability to detect an application software which a malicious code included. So, this paper proposes an application verification system to decide existence and nonexistence of a malicious code in the application software. The proposed application verification system with a mechanism that grasps the flow type of malicious code, can make a reduction of a damage for computer users before the application software executed.

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The Immunogenicity and Safety Study of 47 Passaged Oka Strain Live Attenuated Varicella Vaccine in Healthy Children (건강한 소아에서의 47계대 Oka주 수두약독화 생백신의 면역원성 및 안전성에 관한 연구)

  • Kang, Jin Han;Kim, Jong Hyun;Suh, Byung Kyu
    • Pediatric Infection and Vaccine
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    • v.4 no.2
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    • pp.257-264
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    • 1997
  • Purpose: We performed this study to find out short period humoral immunogenicity and safety of 47 passaged Oka strain live attenuated varicella vaccine(1,400PFU) in 12 months to 15 years aged healthy children. Methods: Ninety nine healthy chidren, who have no histories of varicella vaccination, recent chicken pox illness and contact, allergy to other vaccines and underlying severe diseases, were involved in this study from April 1997 to August 1997. 5ml blood were collected before vaccination and after vaccination from all vaccinees to measure varicella membrane antibody by FAMA, and varicella IgG antibody by EIA. And immediate reactions within 30 minutes after vaccination, local and systemic reactions within 3 days after vaccination and vaccine induced systemic illness during 6 weeks postvaccination period were observed in all vaccinees to identify side effects of study vaccine. Results: 1) 49 seronegative and 50 seropositive vaccinees were identified in both prevaccination serologic tests. 2) Serologic responses after vaccination measured by the FAMA in seronegative group showed that the mean GMT level revealed 64.0, and seroconversion rate was 97.9%. And serologic responses after vaccination measured by the FAMA in seropositive group showed that the mean GMT level(242.2) was markedly elevated comparing with the mean GMT level(9.2) of pre vaccination. 3) The results of EIA in seronegative group revealed that postvaccination mean GMT was 435.2(prevaccination GMT; 78.7), and 100% seroconversion rate. Also, the results of EIA in seropositve group showed that the mean GMT level(769.9) of postvaccination was almostly two fold hihger than the mean GMT level(419.7) of prevaccination. 4) Observed local reactions like injection sites redness, pain, hardness and itching sense were mild and disappeared within 3 days, also shorterm systemic reactions like irritability, lethargy, poor appetites and rash were not remarkable. And there were no remarkable side effects due to vaccine during study period in all vaccinees. Conclusion: We confirmed that 47 paasaged Oka strain live attenuated varicella vaccine has high shorterm humoral immunogenicity and safety. However, we need more detail and longterm humoral and cell mediated immunogenicity studies of this vaccine including clinical field trials.

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Evaluation on efficacy of β-hemolytic Streptococcus iniae vaccine on olive flounder, Paralichthys olivaceus (β-용혈성 Streptococcus iniae 불활화백신의 넙치에 대한 효능 평가)

  • Moon, Jin-San;Jang, Hwan;Kim, Ji-Yeon;Joh, Seong-Joon;Kim, Min-Jeong;Son, Seong-Wan
    • Korean Journal of Veterinary Research
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    • v.47 no.3
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    • pp.291-298
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    • 2007
  • Olive flounder, Paralichthys olivaceus is one of the most important cultured fish in Korea, its farming has been negatively impacted by viral, bacterial and parasitic diseases. Streptococcal infection was considered as a serious problem because of significant economic losses in olive flounder farm industry. The development and evaluation of vaccine for protection against infection by this agent were required. We evaluated the safety and efficacy of ${\beta}$-hemolytic Streptococcus (S.) iniae vaccine on olive flounder Three hundreds of flounders (weight $119.8{\pm}20.7g$, body length $22.6{\pm}1.4cm$) were reared in 0.5 tons aquaria in land-marine tank system. Seawater was provided from the sea of Inchon in Korea, and water temperature was set to $22^{\circ}C$ and $25^{\circ}C$ in the vaccination and challenge test, respectively. We used the formalin-inactivated ${\beta}$-hemolytic S. iniae (F2K) vaccine (M VAC INIAE; Kyoritsu seiyaku, Japan) originated in Japan. The vaccine was intraperitoneally administered to fish. Both of vaccinated group and control group were challenged with intraperitoneally injection by virulent S. iniae SI-36 isolates with $1.0{\times}10^7CFU/fish$ at 3 weeks after vaccination. Difference on mortality of control and vaccinated group (90.0 and 15.0%, 76.5 and 8.0% respectively) at two trials were found significant (p<0.05), and relative percent survival were 83.4% and 89.5%, respectively. The dead fishes were showed dark pigmentation of skin, abdominal extension, hemorrhagic ascites, and liver necrosis, and isolated the S. iniae strain from ascites, liver and kidney. We confirmed the safety and efficacy of ${\beta}$-hemolytic S. iniae vaccine by determinations of the optimal management condition and artificial challenge test in olive flounder.

Potential of Fucoidan Extracted from Seaweeds as an Adjuvant for Fish Vaccine (해조류 유래 Fucoidan의 어류용 백신 항원보조제로서의 가능성에 대한 고찰)

  • Min, Eun Young;Kim, Kwang Il;Cho, Mi Young;Jung, Sung-Hee;Han, Hyun-Ja
    • Journal of Marine Life Science
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    • v.4 no.1
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    • pp.1-13
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    • 2019
  • Fucoidan is a physiologically functional ingredient extracted from seaweed brown algae, which is a sulfated polysaccharide containing fucose as a main molecule backbone. Fucoidan has a variety of immune-modulating or -stimulating effects, including promoting antigen uptake and enhancing anti-bacterial, anti-viral and anti-tumor effects. In addition, recent studies have suggested the possibility of use of fucoidan as a vaccine adjuvant in the field of human vaccine. Use of fucoidan as supplementary feeds have already been studied, but the development of fucoidan as an adjuvant of fish vaccine is still premature. However, the intracellular uptake of fucoidan differs depending on the molecular weight of fucoidan, and there is a limit to the study on specific immune response including the production of antibodies to fish caused by an artificial infection of pathogen. Although the safety of fucoidan has been demonstrated in animal cells, there is a need to confirm the safety of fucoidan in fish. Therefore, active research in this field is needed to use fucoidan as a vaccine adjuvant. This study discussed the effects of fucoidan on immune stimulation, humoraland cellular- immunity including humans and animals. The prospect of fucoidan as a vaccine adjuvant in fisheries also reviewed.