• Proceedings of the PSK Conference
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• 2003.10b
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• pp.180.3-180.3
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• 2003

This study was carried out to examine stability of biological products(BCG vaccine), freeze-dried BCG vaccine for percutaneous use and for interdermal use.1. pH tests of freeze-dried BCG vaccine for percutaneous use and for interdermal use vaccine was suited to basic range with variable temperature. freeze-dried BCG vaccine for percutaneous use was resulted with 6.2-6.7 and for interdermal use was resulted with 6.2-6.7.2. Bacterial concentration test of freeze-dried BCG vaccine for percutaneous use and for interdermal use vaccine was suited to basic range with variable temperature. (omitted)

• Tuberculosis and Respiratory Diseases
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• v.72 no.4
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• pp.374-380
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• 2012

Background: Delivery of Bacille Calmette-Gur$\acute{e}$in (BCG) Tokyo vaccine, with the multipuncture device, has been much preferred over BCG Pasteur, with the intradermal method, possibly due to the easier manner of administration, a desire to avoid any trouble with scars, as well as side effects and higher profits to providers in South Korea. Methods: To determine BCG scar status in 0~6 year old children vaccinated with two BCG vaccines (Pasteur BCG vaccine with intradermal method and BCG Tokyo vaccine with percutaneous method), the data from the national BCG scar survey in 2006 was analyzed. Results: Based on the national survey, the high proportion that were vaccinated with BCG Tokyo vaccines with the multipuncture method (64.5%) was noted in 0~6 year old Korean children. From inspection of scar formation, as an indicator of vaccination, the median number of the visible pin scars from the percutaneous method was 16 (interquartile range, 12~18) in the Korean children, and pin scars decreased as the age of the children increased (p<0.001). Conclusion: The findings in this survey clearly showed a growing preference of parents for the BCG Tokyo vaccines by the multipuncture method in South Korea.

• Tuberculosis and Respiratory Diseases
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• v.84 no.1
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• pp.13-21
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• 2021

Several clinical trials are being conducted worldwide to investigate the protective effect of the bacillus Calmette-Guérin (BCG) vaccine against death in healthcare providers who are working directly with coronavirus disease 2019 (COVID-19) patients. Clinical studies suggested that certain live vaccines, particularly the BCG vaccine, could reduce the mortality due to other diseases caused by non-targeted pathogens, most probably through the nonspecific effects (heterologous effects). By the end of May 2020, the available information on the COVID-19 pandemic indicated the great effect of the BCG vaccine in reducing the number of COVID-19 death cases. The occurrence of death due to COVID-19 was found to be 21-fold lower in countries with a national BCG vaccination policy than in countries without such a policy, based on the medians of COVID-19 death case per 1 million of the population in these two groups of countries (p<0.001, Mann-Whitney test). Therefore, it can be concluded that the early establishment of a BCG vaccination policy in any country is a key element in reducing the number of COVID-19 and tuberculosis death cases.

• 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.

• Korean Journal of Veterinary Research
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• v.52 no.2
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• pp.89-97
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• 2012

Mycobacterial cell-wall skeleton (CWS) is an immunoactive and biodegradable particulate adjuvant and has been tried to use for immunotherapy. The CWS of Mycobacterium bovis bacillus Calmette-Guerin (BCG-CWS) was studied as an universal vaccine vehicle for antigen conjugation, to develop potentially effective and safe vaccine. Although a variety of biological activities of BCG-CWS have been studied, the effects of BCG-CWS on spleen cells are not fully elucidated. Using MTT assay and trypan blue exclusion test, we found that BCG-CWS significantly enhanced the viability and proliferation of cells. Multiple clusters, indicating proliferation, were observed in BCG-CWS-treated spleen cells and surface marker staining assay revealed that BCG-CWS promoted the proliferation of $CD19^+$ B lymphocyte rather than $CD4^+$ or $CD8^+$ T lymphocyte. In addition, BCG-CWS up-regulated the expression of anti-apoptotic molecules such as bcl-2, bcl-xL. BCG-CWS increased the surface expression of CD25 and CD69 as well as IL-2 production of spleen cells, suggesting increased activation. Furthermore, BCG-CWS enhanced the antigen-specific cell proliferation and interferon-gamma production of spleen cells. Taken together, these results demonstrate the immunostimulatory effects of BCG-CWS on spleen cells via multiple mechanisms, providing valuable information to broaden the use of BCG-CWS in clinical and research settings.

• Pediatric Infection and Vaccine
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• v.18 no.1
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• pp.91-96
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• 2011

Bacille Calmette-Gu$\acute{e}$rin (BCG) vaccine is a live attenuated vaccine derived from Mycobacterium bovis. Frequent complications after BCG vaccination are localized ulcer formation and regional lymphadenitis, but there could be rarely severe systemic reactions to BCG vaccine such as osteomyelitis and disseminated BCG infection. Although disseminated BCG infection can be complicated in infants with underlying immunodeficiency after BCG vaccination, it is very unlikely to develop in immunocompetent infants or children. We report a 13-month-old infant who presented with fever, skin nodules, and multiple enlarged lymph nodes 5 months following BCG vaccination. She was diagnosed with disseminated BCG infection by PCRconfirmed M. bovis BCG infection at ${\geq}$2 anatomical sites beyond the region of vaccination. The patient showed no obvious evidence of immunodeficiency as judged on the basis of previous disease history, plasma immunoglobulin levels, B and T lymphocytes counts in peripheral blood, DHR (dihydrorhodamine 123 fluorescence) test and HIV test. She started antituberculous treatment with isoniazid and rifampin, and now, apparently her symptoms have been improved.

• Tuberculosis and Respiratory Diseases
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• v.57 no.2
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• pp.125-131
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• 2004

Tuberculosis (TB) remains an enormous global health problem, and a new vaccine against TB more potent than the current inadequate BCG vaccine is urgently needed. We constructed three recombinant Mycobacterium bovis BCG (rBCG) strains over-expressing antigen (Ag) 85A, Ag85B, or both of M. tuberculosis using their own promoter and secretory sequence, or hsp60 promoter. SDS-PAGE analysis of rBCG proteins showed overexpression of Ag85A and Ag85B proteins in higher level than of those in their parental strain of BCG. In addition, rBCG(rBCG/B.FA) over-expressing Ag85A and Ag85B induced strong IFN-${\gamma}$ production in splenocytes. However, there was no significant difference in protective efficacy between rBCG and their parental BCG strain. In this study, therefore, rBCG over-expressing Ag85A, Ag85B, or both failed to show enhanced protection against M. tuberculosis infection in a mouse model.

• Clinical and Experimental Pediatrics
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• v.52 no.6
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• pp.667-673
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• 2009

Purpose : Toll-like receptor 2 (TLR2) is critical in the immune response to mycobacterial infections. The purpose of this study was to analyze TLR2 surface expressions and TLR2-mediated tumor necrosis factor-alpha ($TNF-{\alpha}$) and interleukin-6 (IL-6) production in patients with BCG vaccine-associated suppurative lymphadenitis. Methods : Peripheral monocytes were separated from 16 patients with BCG vaccine-associated suppurative lymphadenitis and 10 healthy controls using a magnet cell isolation kit. Monocytes ($1{\times}10^6$ cells/well) were incubated with a constant amount of $Pam_3CSK_4$ ($100{\mu}g/mL$) for 24 hours. TLR2 surface expression on monocytes was analyzed by FACS analysis and TLR-2 mRNA expression was determined by RT-PCR. TLR2-mediated $TNF-{\alpha}$ and IL-6 production were measured by ELISA. Results : In patients with BCG vaccine-associated suppurative lymphadenitis, low TLR2 expression on monocytes ($3.39{\pm}$1.2% versus $4.64{\pm}2.6%$) together with significantly lower TLR2 mRNA expression than in the healthy controls was seen after $Pam_3CSK_4$ stimulation. TLR2-mediated $TNF-{\alpha}$ and IL-6 production in patients with BCG vaccine-associated suppurative lymphadenitis ($TNF-{\alpha}$, $775.5{\pm}60.8pg/mL$; IL-6, $4,645.8{\pm}583.9pg/mL$) were also lesser than that in healthy controls ($TNF-{\alpha}$, $1,098.5{\pm}94.3pg/mL$; IL-6, $6,696.3{\pm}544.3pg/mL$). Conclusion : These findings suggest that low TLR2 expression on monocytes might be associated with increased susceptibility to BCG vaccine-associated suppurative lymphadenitis.

• Journal of Microbiology and Biotechnology
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• v.28 no.1
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• pp.136-144
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• 2018

Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis. Bacillus Calmette-$Gu\acute{e}rin$ (BCG) vaccine is the only TB vaccine currently available, but it is not sufficiently effective in preventing active pulmonary TB or adult infection. With the purpose of developing an improved vaccine against TB that can overcome the limitations of the current BCG vaccine, we investigated whether adjuvant formulations containing de-O-acylated lipooligosaccharide (dLOS) are capable of enhancing the immunogenicity and protective efficacy of TB subunit vaccines. The results revealed that the dLOS/dimethyl dioctadecyl ammonium bromide (DDA) adjuvant formulation significantly increased both humoral and Th1-type cellular responses to TB subunit vaccine that are composed of three antigens, Ag85A, ESAT-6, and HspX. The adjuvanted TB vaccine also effectively induced the Th1-type response in a BCG-primed mouse model, suggesting a potential as a booster vaccine. Finally, the dLOS/DDA-adjuvanted TB vaccine showed protective efficacy against M. tuberculosis infection in vitro and in vivo. These data indicate that the dLOS/DDA adjuvant enhances the Th1-type immunity and protective efficacy of the TB subunit vaccine, suggesting that it would be a promising adjuvant candidate for the development of a booster vaccine.

• Parasites, Hosts and Diseases
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• v.52 no.3
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• pp.251-256
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• 2014

A novel recombinant Bacille Calmette-Guerin (rBCG) vaccine co-expressed Eimeria tenella rhomboid and cytokine chicken IL-2 (chIL-2) was constructed, and its efficacy against E. tenella challenge was observed. The rhomboid gene of E. tenella and chIL-2 gene were subcloned into integrative expression vector pMV361, producing vaccines rBCG pMV361-rho and pMV361-rho-IL2. Animal experiment via intranasal and subcutaneous route in chickens was carried out to evaluate the immune efficacy of the vaccines. The results indicated that these rBCG vaccines could obviously alleviate cacal lesions and oocyst output. Intranasal immunization with pMV361-rho and pMV361-rho-IL2 elicited better protective immunity against E. tenella than subcutaneous immunization. Splenocytes from chickens immunized with either rBCG pMV361-rho and pMV361-rho-IL2 had increased $CD4^+$ and $CD8^+$ cell production. Our data indicate recombinant BCG is able to impart partial protection against E. tenella challenge and co-expression of cytokine with antigen was an effective strategy to improve vaccine immunity.