• Toxicological Research
• /
• v.9 no.2
• /
• pp.225-232
• /
• 1993

SCi-B-Vac, the 3rd hepatitis B vaccine , was selected for clinical evaluation on the basis of toxicologic profiles in preclinical studies. These studies were performed to obtain information on its toxic signs, organs which are mainly affected, and to estimate its lethality in mice and rats given Sci-B-Vac through two routes of administratin. In male and female rats given a single intragastrical dose of Sci-B-Vac, we estimated that $LD_{50}$ values were over 2.00 ml/100g B.W. (10ng/ml), respectively.

• Pediatric Infection and Vaccine
• /
• v.4 no.1
• /
• pp.106-115
• /
• 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.

• Pediatric Infection and Vaccine
• /
• v.18 no.2
• /
• pp.124-134
• /
• 2011

Purpose : We have tried to search all concerning data on the policies of hepatitis B vaccination or surveillance of medical equipments that can transmit blood mediated diseases, including disposable syringe, in Republic of Korea, to propose references to other medical professionals. Methods : Data from domestic journals, government websites, computerized newspapers, etc. were reviewed. The data were arranged into four categories (governmental policies on hepatitis B control, hepatitis B mass immunization program in school, using process of hepatitis B vaccine, and policies on medical equipments surveillance, including disposable syringes, which is considered as source of blood mediated infection), and the periodic changes on each subjects in policies were reviewed. Results : Due to growing social concerns on hepatitis B in early 1980s, swift introduction and production of hepatitis B vaccine was made. After establishment of "5 year project for eradication of hepatitis B" in late 1983, number of vaccinated population jumped up to 6 million within 2 years (1984-85). However, since the immunization targets were mainly adult, not infant, this project was annulled in late 1985. Following this project, hepatitis B mass immunization program in school was carried out. In year 1995, hepatitis B vaccine was included in national immunization program. The use of disposable syringe was recommended from year 1980 but legislated in year 1985, finally. Conclusion : The mainstay in controlling hepatitis B in Republic of Korea was coordination of prompt introduction of vaccine, mass immunization, high vaccination coverage rate, or use of disposable syringes. However, since there is lack of official data available, it is urgent to arrange and computerize all government data related to infectious diseases.

• Clinical and Experimental Pediatrics
• /
• v.51 no.7
• /
• pp.696-703
• /
• 2008

Korea is now classified as an area of intermediate endemicity for hepatitis B virus (HBV), due to the implementation of universal HBV vaccination and national preventive programs for HBV infection. A national program of HBV vaccination was launched in Korea in 1988 for school-going children and was listed on a vaccination guideline in 1991. In 1995, universal vaccination for newborn infants was started for the prevention of perinatal HBV transmission. The prevalence of HBsAg among Korean middle school students has shown marked decreased from 3.2% in the late 1990s to 0.44% in 2007. HBsAg positivity in preschool children was 0.9% in 1995, decreased to 0.2% in 2007 by national prevention program of hepatitis B vertical transmission, launched in 2002. Vaccine failure rate of HBV immunoprophylaxis is 4.2% by this program. The infected children should be monitored per 6-12 months interval. Lamivudine and interferon are approved therapies for children with chronic hepatitis B in immune-clearance phase in Korea.

• Animal cells and systems
• /
• v.3 no.3
• /
• pp.337-341
• /
• 1999

Hepatitis C virus (HCV) is a positive strand RNA virus of the Flaviviridae family and the major cause of post-transfusion non-A, non-B hepatitis. Vaccine development for HCV is essential but has been slowed by poor understanding of the type of immunity that naturally terminates HCV infection. The DNA-based immunization technique offers the potential advantage of including cellular immune responses against conserved internal proteins of a virus, as well as the generation of antibodies to viral surface proteins. Here, we demonstrate that cell lines expressing the HCV core and/or NS3 proteins can induce a specific CTL response in mice, and these results suggest a possibility that the HCV core and NS3 DNA can be used to induce CTL activity against the antigen in mice and can be further developed as a therapeutic and preventive DNA vaccine.

• Plant Biotechnology Reports
• /
• v.2 no.1
• /
• pp.1-6
• /
• 2008

Cotyledonary leaves of tomato cv. Megha were transformed with the hepatitis B virus 's' gene, which encodes surface antigen. Six plant expression cassettes (pHBS, pHER, pEFEHBS, pEFEHER, pSHER and pEFESHER) were used to assay the possible expression levels by agroinfiltration. The maximum transient expression level of 489.5 ng/g D.W. was noted in pEFEHER-infiltrated cotyledonary leaves. Transgenic tomato plants with pEFEHBS and pEFEHER expression cassettes were regenerated and characterized by molecular analysis. The expression of the antigen in the fruits was confirmed by RT-PCR and ELISA analysis. This is the first report on the expression of hepatitis B surface antigen in tomato.

• Clinical and Experimental Pediatrics
• /
• v.64 no.12
• /
• pp.602-607
• /
• 2021

In April 2020, the Ministry of Food and Drug Safety licensed a hexavalent combined diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib) conjugated to tetanus protein, and hepatitis B (HepB) (recombinant DNA) vaccine, DTaP-IPV-Hib-HepB (Hexaxim, Sanofi Pasteur), for use as a 3-dose primary series in infants aged 2, 4, and 6 months. The DTaP-IPV-Hib-HepB vaccine is highly immunogenic and safe and provides a long-term immune response based on studies performed in a variety of settings in many countries, including Korea. This report summarizes the Committee on Infectious Diseases of the Korean Pediatric Society guidelines for the use of this newly introduced hexavalent combination vaccine.

• Proceedings of the PSK Conference
• /
• 2003.10b
• /
• pp.162.1-162.1
• /
• 2003

Endotoxin has been detected by the Limulus amoebocyte lysate (LAL) test. However, aluminum hydroxide used as an adjuvant and adsorbent for the recombinant protein antigen is known to increase efficacy of lipopolysaccharide vaccine in vivo thus interfering endotoxin test. The aim of this study is to determine effect of aluminum hydroxide on the LAL test using the hepatitis B vaccine as a model and to optimize the LAL test condition not to be interfered by aluminum gydroxide. (omitted)

• Nuclear Medicine and Molecular Imaging
• /
• v.40 no.1
• /
• pp.48-50
• /
• 2006

A 38-year-old female with arthralgia in right elbow joint for 6 months was referred for a bone scan which showed diffuse uptakes of $^{99m}Tc$-MDP in the liver and spleen without hepatosplenomegaly. She had a history of hepatitis B vaccination 3 days ago. These uptakes were disappeared on the follow-up bone scan after 4 months. We suggest this transient diffuse hepatic uptake after vaccination of hepatitis B might be due to aluminum component within the hepatitis B vaccine as adjuvant.

• BMB Reports
• /
• v.40 no.6
• /
• pp.1002-1008
• /
• 2007

PreS domain of Hepatitis B virus (HBV) surface antigen is a good candidate for an effective vaccine as it activates both B and T cells besides binding to hepatocytes. This report deals with overexpression and purification of adr subtype of surface antigen that is more prevalent in Pakistan. PreS region, comprising 119 aa preS1 region plus a 55 aa preS2 region plus 11 aa from the N-terminal S region, was inserted in pET21a+ vector, cloned in E. coli $DH5\alpha$ cells and expressed in E. coli BL21 codon+ cells. The conditions for over expression were optimized using different concentrations of IPTG (0.01-5 mM), and incubating the cells at different temperatures (23-$41^{\circ}C$) for different durations (0-6 h). The cells were grown under the given optimized conditions (0.5 mM IPTG concentration at $37^{\circ}C$ for 4 h), lysed by sonication and the protein was purified by ion exchange chromatography. On the average, 24.5 mg of recombinant protein was purified per liter of culture. The purified protein was later lyophilized and stored at $-80^{\circ}C$.