• The Journal of the Korean Society for Microbiology
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• v.21 no.2
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• pp.243-249
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• 1986

A study of the immunogenicity and reactogenicity of two doses of lot H(10, 20 mcg), two doses of lot L (20, 40 mcg) of the Smith Kline-RIT recombinant DNA yeast-derived hepatitis B vaccine and a 20-mcg dose of the Merck Sharp and Dohme plasma-derived hepatitis B vaccine was conducted in young adults under randomized, double-blind conditions. Immunization was carried out according to a 0-, 1-, and 6-month vaccination schedule. Results indicated that the yeast-derived hepatitis B vaccine was well tolerated and immunogenic. Reactogenicity to both yeast- and plasma-derived vaccines was mild in severity and low in incidence with no significant differences appearing between the study groups. One month after the third dose, the yeast-derived vaccines induced a high degree of soroconversion ranging between 95.0% and 100%. The response was not lot or dose-dependent. The administration of the plasma-derived vaccine resulted in anti-HBs geometric mean titres statistically signifirantly higher than those elicited by the different yeast-derived hepatitis B vaccines one month after the third dose of vaccine but the difference was not large enough to be of great clinical significance.

• The Journal of Korean Society of Virology
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• v.27 no.2
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• pp.143-149
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• 1997

Most of the current licenced hepatitis B vaccines are being produced by recombinant DNA technology in large fermentation cultures of Saccharomyces cerevisiae of yeast cells which carry the gene coded for hepatitis B virus surface antigen. These vaccines are proved very effective clinically and the immunogenicity of vaccines could be maintained for a long time under refrigeration. To develope the stabilizer that could increase the stability of hepatitis B virus vaccine which could be stored for a long period at room temperature or higher conditions, glucose, lactose and sucrose solutions in phosphate buffered saline were added into hepatitis B vaccine respectively to make 2.5%, 5%, 7.5% and 10% final concentration in vaccines. These sugar-vaccine mixtures were stored at room temperature for one month, two months and three months respectively and then inoculated into ICR mice intramuscularly. On the fourteenth day after inoculation, mice were bled and sera were tested for the evaluation of efficacies of vaccines. The results showed that 5% glucose, 7.5% lactose and sucrose increased the stability of vaccines in some degree and this method could be applied for the production of other viral vaccines and bacterial vaccines.

• Korean Journal of Health Education and Promotion
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• v.23 no.4
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• pp.89-104
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• 2006

Objectives: This study was done to find factors related with performance of hepatitis B Vaccination among some aged persons through health belief model. Methods: A questionnaire survey was made during September 2004 toward 230 elderly persons using institutions for the elderly of Gwangju City. The relations between subjects characteristics including health belief, mass media contact, hepatitis B experience and performance of hepatitis B vaccination were tested by t test or X2 test. Multiple logistic regression analysis was done to find final significantly related variables. Results: 24.8% of the subjects were vaccinated against hepatitis B. By simple analysis of relation between performance of hepatitis B vaccination and subjects characteristics including health belief, significant variables were chosen as 6 variables including perceived susceptibility, perceived seriousness, perception of benefits, knowledge on hepatitis B, age, experience of hepatitis through family or friend. After adjusting for confounding variables by multiple logistic regression analysis, hepatitis B vaccine performance showed significantly higher rate as the perception of disease seriousness increased(OR: 1.08, 95% CI: $1.03{\sim}1.14$) and in the group contacted with TV or radio information about hepatitis compared with non-contact. The group who experienced hepatitis among family or friends showed significantly higher hepatitis B vaccination performance rate compared with non-experienced. Conclusion: These results suggested that hepatitis B vaccine performance was related with health belief including hepatitis susceptibility, disease seriousness perception, acquisition of information through TV or radio and indirect hepatitis experience from family or friends.

• Toxicological Research
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• v.2 no.1
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• pp.23-30
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• 1986

Acute toxicity study was conducted on a Hepatitis B vaccine (Hepaccine-B-inj.) with mice, guinea pigs, and rabbits, in accordance with the norms suggested by the F.D.A. in U.S.A. Dose ranges were 2 doses/mouse, 5 doses/guinea pig, 10 doses/rabbit. They received the vaccine subcutaneously and intraperitoneally. Thereafter, all animals injected were observed of general signsdaily, and of body weight for two weeks. At the end of the observation period (or at the time of death), all animals received the highest dose group were autopsied and gross observation was made on various organs and tissues. No significant toxicity was noted.

• Journal of Preventive Medicine and Public Health
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• v.20 no.2 s.22
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• pp.280-286
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• 1987

For evaluating the boosting (anamnestic) effects of the most recent commercially produced plasma derived heat-inactivated hepatitis B vaccine (A. Co.), 117 adults with naturally acquired antibody to hepatitis B surface antigen (anti-HBs) were selected at random. In addition, out of case immunized at zero and 1 month, and boosted at 6 months (primary boosting) by conventional vaccine (B. Co), inactivated by pepsin digestion and formalin treatment, 11 cases who showed elevated titer after primary boosting were also submitted to the study. The results were as follows: 1) Out of the 117 subjects with naturally acquired anti-HBs, 6(5.1%) showed isolated anti-HBs and the titers were below 10 ratio units (RU). Negative seroconversion was seen in 4(3.4%) of the 117 cases at 12 months after the screening and, of these cases, 3 showed isolated anti-HBs and the titers were below 10 RU. 2) Eighty-three percent of the cases with naturally acquired isolated anti-HBs below 10 RU did not respond to a booster injection with 3 us dose of A. Co. vaccine at all, but 90% of the other subjects responded. 3) The anti-HBs titers of all the 11 cases who showed a rise of more than 10 RU (increased GMT, 28.04) at one month after primary booster injection by $20{\mu}g$ dose of B. Co. vaccine decreased at 19 months after the primary booster. And 3 subjects (27.3%) of the 11 reached negative seroconversion. All of the 11 cases, who had secondary booster injection with $3{\mu}g$ dose of A. Co. vaccine at 19 months after primary boosting, showed increased anti-HBs titer at least 20 RU or more (increased GMT, 57. 72) at one month after the boosting. According to the above results in the anti-HBs screening survey for the purpose of immunization with hepatitis B vaccine, subjects with isolated anti-HBs below 10 RU should be regarded as being in an unimmunized state. In cases who are in risk circumstances, immunized primarily with a $20{\mu}g$ dose of B. Co. vaccine, a secondary booster injection should be given within 2 years after initiation of primary immunization and a $3{\mu}g$ booster dose of A. Co. vaccine can be reliably used.

• Proceedings of the PSK Conference
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• 2003.04a
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• pp.121-121
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• 2003

The purpose of this study is to investigate the effect of mucosal vaccine delivery vehicles and adjuvants on the local and systemic antibody responses following mucosal immunization of mice with hepatitis B surface antigen (HBsAg). Mice were immunized on days 0 and 21 by administration of hepatitis B surface antigen B (HBsAg) into the vagina. HBsAg was delivered in saline or poloxamer(Pol)-based vehicle containing mucoadhesive polycarbophil (PC). (omitted)

• YAKHAK HOEJI
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• v.45 no.6
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• pp.708-714
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• 2001

Many studies have provided evidences that hepatitis B surface antigen (HBsAg) including preS region could be an ideal candidate for a new hepatitis B virus (HBV) vaccine with higher efficacy. We established CHO cell lines, IY-CHO-2 and IY-CHO-11 expressing high levels of HBsAg containing preS2 and S protein by stable transfection method. These cell lines expressed the correct size (about 1 kb in length) of HBsAg mRNA as expected. The purified protein from the culture supernatants of the clones showed the same sizes as those expressed in native hepatitis B virus (24 kDa, 27 kDa, 34 kDa and 36 kDa). Antibody productivity of CHO-derived HBsAg protein at lower dose challenge was higher than the protein containing S region alone expressed in yeast system. These results indicate that CHO-derived HBsAg protein containing preS2 and S region can be effectively used for a better immune response as a HBV vaccine.

• Pediatric Infection and Vaccine
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• v.15 no.1
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• pp.1-4
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• 2008

Immunizations are among the most cost-effective and widely used public health interventions. This is a report a revision of recommendation of immunization for children by Korean Pediatric Society. Immunization. Vaccines were divided into 4 groups. 1) Vaccines that are recommended to all infants and children (BCG, hepatitis B vaccine, DTaP, Td, Polio vaccine, Japanese encephalitis vaccine, MMR, varicella vaccine, influenza vaccine [6-23 months of age], H. influenzae type b vaccine), 2) those that can be administered to all infants and children, but decision of administration is made by parents (pneumococcal conjugate vaccine, hepatitis A vaccine, influenza vaccine [healthy children ${\geq}24$ months of age], rotavirus vaccine, human papilloma virus vaccine), 3) those that should be given to high risk group (pneumococcal polysaccharide vaccine [high risk patients ${\geq}24$ months of age], influenza vaccine [high risk patients ${\geq}24$ months of age], typhoid vaccine), and 4) those administered for control of outbreaks or prevention of emerging infectious diseases. Immunization schedule recommended by Korean Pediatric Society in 2008 is presented.

• Clinical and Experimental Pediatrics
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• v.49 no.1
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• pp.14-17
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• 2006

Infants who are born prematurely or with low birth weight should be immunized at the same postnatal chronologic age. They should receive BCG, DTaP, IPV vaccines according to the same recommended schedule as full term infants. Hepatitis B vaccine schedule is modified when hepatitis B vaccine is administered a infant with birth weight less than 2,000 g. The recommended standard dose of each vaccine should be administered. Proportion of children experiencing vaccine-related adverse events dose not differ between full-term and preterm infants. Immunization with routinely recommended childhood vaccines is safe for preterm and low birth weight infants.

• Biomolecules & Therapeutics
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• v.2 no.2
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• pp.108-113
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• 1994

Toxicity study of recombinant hepatitis B vaccine (LBD-008), a newly developed drug for acute and chronic hepatitis, was investigated in mice and guinea pigs. 1. Mice showed no production of antibodies against LBD-008 inoculated with aluminum hydroxide gel (Alum) as an adjuvant, judged by the heterologous anaphylaxis (PCA) test using rats. On the other hand, antibodies against ovalbumin (OVA) inoculated with alum were definitely detected. 2. In the studies with guinea pigs, both the inoculation of LBD-008 only and of LBD-008 with complete Freund's adjuvant (CFA) as an adjuvant did not produce positive reactions in any of homologous active systemic anaphylaxis (ASA). On the other hand, the inoculation of ovalbumin with complete Freund's adjuvant (CFA) produced positive reaction in both of PCA and ASA. 3. These findings suggested that LBD-008 has no antigenic potential in mice or guinea pigs.