• Korean Journal of Veterinary Research
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• v.45 no.2
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• pp.215-221
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• 2005

Canine coronavirus (CCV) causes a mild gastroenteritis in dogs. The virus is highly contagious. Although the virus was isolated more than thirty years ago, canine coronavirus infection continues to be a widespread problem. Mixed infections with both CCV and canine parvovirus (CPV) are common. Four kinds of commercial killed CCV vaccines are available in Korea. All the commercial vaccines should pass the National Assay for Veterinary Biologicals prior to release. For the potency test of CCV vaccine, it is necessary to use CCV antibody free dogs. The test requires not only kennels but high cost. To develop easy, efficient and economic potency test method for killed CCV vaccine using laboratory animals, a series of experiments with rabbits and guinea pigs were carried out in this study. In the preliminary test, the guinea pigs showed better immune responses than rabbits. The guinea pig was also easy to manage. So guinea pig was selected for the potency test animals. When the guinea pigs were inoculated twice with one dose of vaccine intramuscuarly each, slower and a little lower SN antibody titers were induced in guinea pigs than in dogs (about 2 kg body weight Beagle strain) given the same posology as guinea pigs'. It was concluded that guinea pigs could be substituted for dogs in the potency test of killed CCV vaccine.

• Pediatric Infection and Vaccine
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• v.10 no.1
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• pp.71-80
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• 2003

Purpose : Four kinds of Haemophilus influenzae type b protein conjugate vaccines, PRPD, PRP-T, PRP-OMP and PRP-CRM197, have been developed, and PRP-T vaccines are currently produced by two manufacturer, $ActHib^{(R)}$ by Aventis and $Hiberix^{TM}$ by GlaxoSmith-Kline Biologicals. The purpose of this study is to evaluate the immunogenicity and safety of $Hiberix^{TM}$ in Korean infants. Methods : Seventy-three healthy infants(43 male infants) were recruited for this study after parental informed consent was obtained. Each infant was vaccinated at 2, 4 and 6 months of age with the study vaccine. At each visit, infants were also immunized with DTaP, trivalent oral polio vaccine and hepatitis B vaccine when indicated. The serum anti-PRP antibody was measured at prevaccination, 2 month later after the 2nd dose, and 1 month later after the 3rd dose by the ELISA method. The local and systemic adverse reactions of vaccination were monitored for 3 consecutive days after each immunization. Immunogenicity of vaccine was evaluated in infants who received all the scheduled immunization and the adverse reactions were evaluated for infants who received at least one dose of the study vaccine. Results : Among seventy three infants, enrolled in this study; sixty three(37 male infants) completed all the scheduled immunizations. The geometric mean titer(GMT) of anti-PRP antibodies at prevaccination was 0.17 ${\mu}g/mL$(95% confidence interval[CI]; 0.13~0.22). The GMT of anti-PRP antibodies increased to 4.14 ${\mu}g/mL$(95% CI; 2.65~6.48) at 2 month later after the 2nd dose of PRP-T and 14.65 ${\mu}g/mL$(95% CI; 10.83~19.81) at 1 month later after the 3rd dose. Anti-PRP antibody ${\geq}0.15$ ${\mu}g/mL$, was observed in 98.4%(95% CI; 91.8~100) after 2 doses and 100%(95% CI; 100~100) after 3 doses. Anti-PRP antibody ${\geq}1.0$ ${\mu}g/mL$, was obtained in 77.8%(95% CI; 67.5~88.0) after 2 doses, and 98.4%(95% CI; 95.3~100) after 3 doses. Most of the adverse reaction after vaccination were mild. Irritability, the most common systemic reaction, was observed in 45.5%, followed by drowsiness(30.5%), poor feeding(26.7%) and fever(5.6%). Among the local reactions tenderness was observed in 7.9%, redness(${\geq}5$ mm) in 2.8% and swelling(${\geq}5$ mm) in 1.8%. Conclusion : The PRP-T vaccine used in this study was highly immunogenic and safe in Korean young infants. The finding that high GMT and high frequency of infants with a protective titer achieved after 2 doses is consistent with the previous studies which were done with a PRP-T vaccine of other manufacturer. This study suggests that the immunization schedule of PRP-T vaccine for Korean infants may need re-evaluation.

• Pediatric Infection and Vaccine
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• v.6 no.2
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• pp.234-238
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• 1999

Purpose : This study was performed to evaluate the seropositivities and levels of Hepatitis A Virus(Hav) antibody in term pregnant women and their neonates, and the transplacental transfer rate of maternal Hav-specific IgG(Hav IgG) from tenn pregnant women to their neonates. Methods : During Jan. 1st, 1998 to May. 31 tho 1998, we collected the 42 pairs of sera from pregnant women and umbilical cord of their neonates in Korea University Ansan Hospital. The serum levels of Hav IgG were measured by the RIA method. Results : 1) The seropositivities of Hav IgG were 78.6% in mothers and 81.0% in neonates. There was no statistical difference of mean antibody(Ab) levels between mothers and neonates. There was significant correlation of Ab levels between maternal sera and neonatal umbilical cord sera(correlation coefficient r=0.9285, P<0.001). 2) There were no significant correlations between neonatal Hav IgG level and other factors such as maternal age, gestational age and initial body weight of neonates. Conclusion : Seropositivities of Hav IgG tenn-pregnant women was comparable to those of their neonates. Pregnant women and their neonates can be protected from Hav infection.

• Korean Journal of Microbiology
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• v.44 no.1
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• pp.14-21
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• 2008

Bovine blood, cell, tissue, and organ are used as raw materials for manufacturing biopharmaceuticals, tissue engineered products, and cell therapy. Manufacturing processes for the biologicals using bovine materials have the risk of viral contamination. Therefore viral validation is, essential in ensuring the safety of the products. Bovine herpesvirus type 1 (BHV-1) is the most common bovine pathogen found in bovine blood, cell, tissue, and organ. In order to establish the validation system for the BHV-1 safety of the products, a real-time PCR method was developed for quantitative detection of BHV-1 in raw materials, manufacturing processes, and final products as well as BHV-1 clearance validation. Specific primers for amplification of BHV-1 DNA was selected, and BHV-1 DNA was quantified by use of SYBR Green I. The sensitivity of the assay was calculated to be $2\;TCID_{50}/ml$. The real-time PCR method was validated to be reproducible and very specific to BHV-1. The established real-time PCR assay was successfully applied to the validation of Chinese hamster ovary (CHO) cell artificially infected with BHV-1. BHV-1 DNA could be quantified in CHO cell as well as culture supernatant. Also the real-time PCR assay could detect $10\;TCID_{50}/ml$ of BHV-1 artificially contaminated in bovine collagen. The overall results indicated that this rapid, specific, sensitive, and robust assay can be reliably used for quantitative detection of BHV-1 contamination during the manufacture of biologics.