• Biotechnology and Bioprocess Engineering:BBE
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• v.10 no.3
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• pp.230-235
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• 2005

For the acellular pertussis vaccine with a high immunogenicity, the concentration, composition and characteristics of acellular pertussis antigens are the crucial points to be considered. Nevertheless, it has not been proved yet whether or not the polymerization degree, one of the characteristics of formalin-detoxified acellular pertussis antigens, has an influence on vaccine potency. Thus, in the present study, the correlations among detoxification conditions of acellular pertussis bulks, their polymerization degrees and their immunogenicities were examined. In addition, the relative importance of pertussis toxoid in vaccine immunogenicity was also investigated. Results show that a lower lysine concentration during detoxification induces highly-polymerized antigens, the immunogenicity has a great dependency on the polymerization degree of antigens, and also pertussis toxoid has a relatively stronger influence on the immunogenicity than other antigens. Accordingly, in the aspect of the potency of detoxified acellular pertussis vaccine, it can be demonstrated that the polymerization of antigens and its degree are the major factors affecting the immunogenicity along with a relatively high content of pertussis toxoid

• Journal of Microbiology and Biotechnology
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• v.13 no.3
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• pp.338-343
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• 2003

Various factors, such as the adsorption pH, adjuvant dose, and adjuvant age, which affect the adsorption degree and immunogenicity of an antigen, were investigated. In addition, the effect of pH, antigen content, and adjuvant content on immunogenicity was also studied through animal experiments. Within the ranges studied, a low pH for adsorption, freshly preformed gel, and low pH formulation for the combined DTwP-HepB vaccine were preferrable for the adsorption of the antigens. In addition, a higher DT content was found to have a positive effect on the HBsAg immunogenicity in the combined vaccine. Accordingly, considering the factors affecting the adsorption rate and immunogenicity of the antigens, a novel DTwP-HepB vaccine (40 Lf/ml of diphtheria toxoid, 15 Lf/ml of tetanus toxoid, 20 OU/ml of detoxified whole cell pertussis, $24\;\mu\textrm{g}$ of HBsAg, $24\;\mu\textrm{g}\;Al/ml\;of \;Al(OH)_3\;gel,\;776\;\mu\textrm{g}\; Al/ml\;of\;AIPO_4\;gel$, and pH 7.1) was developed, whose immunogenicity was comparable to the case of administrating, separately and simultaneously, a combined DTwP vaccine (40 Lf/ml of diphtheria toxoid, 15 Lf/ml of tetanus toxoid, 20 OU/ml of detoxified whole cell pertussis, $300\;\mu\textrm{g}\;Al/ml\;of\; AIPO_4\;gel$, and pH 7.1) and mono HepB vaccine [$Hepavax^{\circledR},\;24\;\mu\textrm{g}/ml$ of HBsAg and $500\;\mu\textrm{g}\;Al/ml\;of\;Al(OH)_3\;gel$], which satisfies the potency criteria of the K-FDA for a combined DTwP vaccine and mono HepB vaccine.

• Pediatric Infection and Vaccine
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• v.25 no.3
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• pp.141-147
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• 2018

Purpose: Despite effectiveness and safety of maternal tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccination, Tdap vaccination coverage during pregnancy remains quite low. We assessed the knowledge, attitude and practice on maternal Tdap vaccination among pregnant women. Methods: This study was a cross-sectional survey of pregnant women who visited tertiary obstetrics and gynecologic units in Seoul and Gyeonggi province of Korea. Individual questionnaires were administered to assess knowledge, attitude and practice on maternal immunization with Tdap. Results: The questionnaires were completed by 184 pregnant women; 158 (86%) had not received information from doctors about pertussis and Tdap, and 166 (90%) did not know the need for Tdap vaccination. Only 7% of pregnant women unlikely to receive Tdap vaccine during current pregnancy answered 3 or more of the 5 knowledge-based questions correctly. By logistic regression analysis, recommendation by doctor (adjusted odd ratio [OR], 236.2; 95% confidence interval [CI], 12.6-4,432), belief that the vaccine is effective (adjusted OR, 40.21; 95% CI, 2.35-687.7), and belief that the vaccine is safe (adjusted OR, 19.83; 95% CI, 1.54-255.9) were significantly important factors to respondents' intention to be vaccinated. Conclusions: Most pregnant women seem to be neither recommended nor adequately informed about Tdap vaccination. Information given by health care professionals is very important to increase Tdap coverage among pregnant women.

• Environmental Mutagens and Carcinogens
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• v.11 no.2
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• pp.134-140
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• 1991

B형 간염바이러스의 표면항원, 파상풍, 디프테리아균의 toxoid, 백일해의 혼합백신인 PDT-Hepa의 효능을 실험하여 다음과 같은 결과를 얻었다. 시험물질을 기니픽에 접종하였을 때 B형 간염 바이러스의 표면 항원과 파상풍 및 디프테리아균의 toxoid에 대한 항체형성이 뚜렷이 관찰되었으며, 항체형성의 정도는 접종용량에 비례하였다. 백일해의 경우는 시험물질을 마우스에 접종시킨 후 마우스에 감수성이 있는 Bordetella pertussis 18323주로 직접 공격 접종하여 이 균에 대한 방어력이 형성되어 있음을 관찰하였으며, 이러한 방어정도는 투여 용량에 비레함을 알 수 있었다.

• Journal of Microbiology and Biotechnology
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• v.12 no.5
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• pp.787-792
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• 2002

When developing a combined DTaP-HepB vaccine, toxicity and HBsAg immunogenicity are both important considerations. Thus, for a combined DTaP-HepB vaccine with a low toxicity, the effect of the DTaP content and $Al(OH)_3$, gel concentration on the vaccine toxicity was investigated. Within the range studied, the higher the concentrations, the higher the vaccine toxicity. The importance of the tetanus toxoid content in the combined DTaP-HepB vaccine was also revealed. A higher concentration of the tetanus toxoid was found to have a negative effect on the stability of the HBsAg immunogenicity in the combined vaccine. Accordingly, considering the factors affecting toxicity and HBsAg immunogenicity, a novel DTaP-HepB vaccine (30 Lf/ml of diphtheria toxoid, 5 Lf/ml of tetanus toxoid, 10 $\mu\textrm{g}$ PN/ml of acellular pertussis, 24 $\mu\textrm{g}$/ml of HBsAg, and 500 $\mu\textrm{g}$ Al/ml of $Al(OH)_3$ gel) was developed. It has a low toxicity and a stable HBsAg immunogenicity and also satisfies the potency criteria of K-FDA for a combined DTaP vaccine.

• Journal of Microbiology and Biotechnology
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• v.22 no.6
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• pp.856-865
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• 2012

We describe the construction and immunobiological properties of a novel whooping cough vaccine candidate, in which the aroQ gene, encoding 3-dehydroquinase, was deleted by insertional inactivation using the kanamycin resistance gene cassette and allelic exchange using a Bordetella suicide vector. The aroQ B. pertussis mutant required supplementation of media to grow but failed to grow on an unsupplemented medium. The aroQ B. pertussis mutant was undetectable in the trachea and lungs of mice at days 6 and 12 post-infection, respectively. Antigen-specific antibody isotypes IgG1 and IgG2a, were produced, and cell-mediated immunity [CMI], using interleukin-2 and interferon-gamma as indirect indicators, was induced in mice vaccinated with the aroQ B. pertussis vaccine candidate, which were substantially enhanced upon second exposure to virulent B. pertussis. Interleukin-12 was also produced in the aroQ B. pertussis-vaccinated mice. On the other hand, neither IgG2a nor CMI-indicator cytokines were produced in DTaP-vaccinated mice, although the CMI-indicator cytokines became detectable post-challenge with virulent B. pertussis. Intranasal immunization with one dose of the aroQ B. pertussis mutant protected vaccinated mice against an intranasal challenge infection, with no pathogen being detected in the lungs of immunized mice by day 7 post-challenge. B. pertussis aroQ thus constitutes a safe, non-reverting, metabolite-deficient vaccine candidate that induces both humoral and cell-mediated immune responses with potential for use as a single-dose vaccine in adolescents and adults, in the first instance, with a view to disrupting the transmission cycle of whooping cough to infants and the community.

• Pediatric Infection and Vaccine
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• v.21 no.2
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• pp.114-120
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• 2014

Purpose: The objective of this study was to assess and investigate the epidemiology of pertussis in infants under 6 months of age. Methods: A prospective study was conducted between October 1, 2011 and April 30, 2013 in CHA Bundang Medical Center, Seongnam, South Korea. Polymerase chain reaction (PCR) or culture was used to detect Bordetella pertussis in nasopharyngeal aspirates from case patients who were hospitalized for acute lower respiratory tract infection (LRTI). In addition, multiplex real-time PCR assays were also performed to detect 6 etiologic viruses, including adenovirus, human metapeumo-virus, influenza virus, parainfluenza virus, respiratory syncytial virus and rhinovirus. Results: Of the 79 enrolled case patients, whose median age was 2 months of age, the most common diagnoses uncovered in this study were acute bronchiolitis (60%) and pneumonia (28%). B. pertussis infection was found in 13 cases (16%), in which 7 (53%) was coinfected with respiratory syncytial virus and 1 (7%) with influenza A virus. Of the 13 patients with B. pertussis infection, 6 (46%) were not vaccinated with the diphtheria, tetanus toxoid, and acellular pertussis vaccine, while 6 (46%) received 1 dose, and 1 (8%) received 2 doses. Conclusion: B. pertussis infection was present in 16% of under 6 month-old infants, who were hospitalized for acute LRTI. Therefore, a nationwide epidemiological surveillance of pertussis, including institutions that cater to infants under 6 months of age is necessary and needed.

• 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.