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Jung Soo Kim,
Chong-Woo Bae,
Kyung-Yil Lee,
Moon Sung Park,
Young Youn Choi, Kwang-Nam Kim,
Jong Duck Kim,
Won-Soon Park,
Jong-Beom Sin,
Ellen Ai-Rhan Kim, [......],
Chun Soo Kim,
Sung-Ho Cha,
Young Jin Hong,
Son-Moon Shin,
Gyu-Hong Shim,
Kyong Min Choi,
Jun Won Yang,
Aixue Liu,
P V Suryakiran,
Htay Htay Han
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ABSTRACT: Rotavirus (RV) infection is the primary cause for childhood gastroenteritis worldwide. In Korea, RV infection is most common among children less than 5 years of age. This post-licensure study was conducted to further evaluate the RV vaccine (RIX4414) to provide additional local clinical data to the Korean Food and Drug Association. Healthy infants aged 6-12 weeks were enrolled to receive two doses of either RIX4414 or placebo as per 0, 1-2 month schedule. Blood samples were collected before dose-1 and one month post-dose-2 of RIX4414/placebo to assess serum anti-RV IgA antibody concentrations using ELISA. Gastroenteritis stool samples were tested for the presence of RV using ELISA. RV positive samples were subjected to further analysis for G and P typing. Among 684 infants enrolled and vaccinated, 432 infants (RIX4414=318; placebo=114) were included in the according-to-protocol cohort for immunogenicity. The anti-RV IgA antibody seroconversion rates in the RIX4414 group following one month post-dose-2 were 88.1% (95% CI: 84.0-91.4) and the corresponding geometric mean concentration in the RIX4414 group was 208.5 U/ml (95% CI: 174.2-249.5). Occurrence of solicited and unsolicited adverse events were similar in both, RIX4414 and placebo groups. None of the gastroenteritis stool samples tested positive for RV and no fatal SAEs were reported in either groups. The two-dose regimen of RIX4414 was observed to be immunogenic with a similar safety profile as compared to the placebo group, when administered to healthy Korean infants.
Human vaccines & immunotherapeutics. 06/2012; 8(6):806-12.
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Chang-Hwi Kim,
Jung Soo Kim,
Sung-Ho Cha, Kwang-Nam Kim,
Jong-Duck Kim,
Kyung Yil Lee,
Hwang Min Kim,
Jong-Hyun Kim,
Sang Hyuk,
Jung-Yun Hong,
Su Eun Park,
Yun-Kyung Kim,
Nam Hee Kim,
Aurélie Fanic,
Dorota Borys,
Javier Ruiz-Guiñazù,
Marta Moreira,
Lode Schuerman,
Kyung-Hyo Kim
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ABSTRACT: This randomized single-blind study in Korea evaluated noninferiority of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) versus the 7-valent pneumococcal conjugate vaccine (7vCRM) when both were coadministered with H. influenzae type b (Hib) conjugate vaccine, as opposed to coadministration with diphtheria-tetanus-acellular pertussis-based combination vaccines in previous studies.
Infants received 3 primary doses at 2, 4, and 6 months and a booster dose at 12 to 18 months of PHiD-CV (N = 374) or 7vCRM (N = 129), both coadministered with Hib vaccine. Immune responses were measured 1 month postdose 3 and postbooster using 22F-inhibition enzyme-linked immunosorbent assay and functional opsonophagocytic activity assay.
PHiD-CV-induced antibody responses against each of the vaccine pneumococcal serotypes and protein D. Noninferiority to 7vCRM was demonstrated for all 10 PHiD-CV serotypes in terms of percentages of subjects reaching an antibody concentration ≥0.2 μg/mL after primary vaccination. Postprimary and postbooster, percentages of subjects with antibody concentration ≥0.2 μg/mL or opsonophagocytic activity titer ≥8 were generally consistent between groups for each pneumococcal serotype common to both vaccines. The safety and reactogenicity profiles of PHiD-CV and 7vCRM were generally comparable after both primary and booster vaccination.
In this Korean study, 3-dose PHiD-CV priming followed by a booster dose was immunogenic for all 10 vaccine pneumococcal serotypes and protein D. Noninferiority to 7vCRM in terms of enzyme-linked immunosorbent assay threshold responses postpriming was demonstrated. The safety and reactogenicity profiles of both vaccines when coadministered with Hib vaccine were generally comparable.
The Pediatric Infectious Disease Journal 08/2011; 30(12):e235-43. · 3.58 Impact Factor
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Kyung Hee Park,
Kyung Hyo Kim,
Jin Han Kang, Kwang Nam Kim,
Dong Soo Kim,
Yun Kyung Kim,
Jung Soo Kim,
Jong Hyun Kim,
Chang Hwi Kim,
Hwang Min Kim,
Sung Hee Oh,
Eun Hee Chung,
Sung Ho Cha,
Young Youn Choi,
Jae Kyun Hur,
Young Jin Hong,
Su Eun Park,
Hoan Jong Lee
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ABSTRACT: Group B streptococcus (GBS) is the most common cause of invasive neonatal infections in developed countries. The incidence of early-onset GBS disease in Korea is known to be much lower than that in other developed countries; however neonatal GBS disease has been frequently reported in recent years in Korea. This retrospective study sought to determine the current status and clinical presentation of neonatal GBS disease in Korea.
From January 1996 through December 2005, GBS cases (n= 157) diagnosed in blood, cerebrospinal fluid, or other sterile body fluids among infants <3 months of age from 14 university hospitals in Korea were identified. Age of onset, diagnosis, underlying medical conditions, and outcomes were investigated by reviewing the medical records.
A total of 157 cases were identified during the study period. Of the cases, 32 were early-onset disease (EOD) and 125 were late-onset disease (LOD). Twenty-six of the EOD cases had symptoms during the first 24 h after birth. One hundred of the 157 GBS cases were diagnosed as meningitis. The mortality rate of EOD was 20.7%. The case fatality rate of LOD was 7.2% and 25.2% of LOD cases had sequelae.
GBS is becoming an important cause of invasive neonatal infections in Korea, with LOD being more common. It may not be currently necessary to adopt the prevention guidelines of perinatal GBS disease in Korea. However, studies of maternal GBS carriage rates and neonatal GBS disease will continue.
Pediatrics International 04/2011; 53(2):236-9. · 0.63 Impact Factor
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Joon-Ho Lee,
Hye Kyung Cho,
Kyung-Hyo Kim,
Chang Hwi Kim,
Dong Soo Kim, Kwang Nam Kim,
Sung-Ho Cha,
Sung Hee Oh,
Jae Kyun Hur,
Jin Han Kang,
Jong Hyun Kim,
Yun-Kyung Kim,
Young Jin Hong,
Eun Hee Chung,
Soo-Eun Park,
Young Youn Choi,
Jung Soo Kim,
Hwang Min Kim,
Eun Hwa Choi,
Hoan Jong Lee
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ABSTRACT: The purpose of this study was to identify the major etiological agents responsible for invasive bacterial infections in immunocompetent Korean children. We retrospectively surveyed invasive bacterial infections in immunocompetent children caused by eight major pediatric bacteria, namely Streptococcus pneumoniae, Haemophilus influenzae, Neisseria meningitidis, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pyogenes, Listeria monocytogenes, and Salmonella species that were diagnosed at 18 university hospitals from 1996 to 2005. A total of 768 cases were identified. S. agalactiae (48.1%) and S. aureus (37.2%) were the most common pathogens in infants younger than 3 months. S. agalactiae was a common cause of meningitis (73.0%), bacteremia without localization (34.0%), and arthritis (50%) in this age group. S. pneumoniae (45.3%) and H. influenzae (20.4%) were common in children aged 3 months to 5 yr. S. pneumoniae was a common cause of meningitis (41.6%), bacteremia without localization (40.0%), and bacteremic pneumonia (74.1%) in this age group. S. aureus (50.6%), Salmonella species (16.9%), and S. pneumoniae (16.3%) were common in older children. A significant decline in H. influenzae infections over the last 10 yr was noted. S. agalactiae, S. pneumoniae, and S. aureus are important pathogens responsible for invasive bacterial infections in Korean children.
Journal of Korean medical science 02/2011; 26(2):174-83. · 0.84 Impact Factor
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ABSTRACT: Thanatophoric dysplasia (TD) is a short-limb neonatal dwarfism syndrome that is usually lethal in the perinatal period. It is characterized by shortening of the limbs, severely small thorax, large head with a prominent forehead, macrocephaly, curved femur, and flattened vertebral bodies. These malformations result from the mutation in fibroblast growth factor receptor 3 (FGFR-3) gene which is located on the short arm of chromosome 4. A definite diagnosis should be established by molecular genetic analysis to find out the abnormal mutations in the FGFR3 gene. We confirmed by detection of a R248C mutation in the FGFR3 gene in DNA analysis.
Korean Journal of Pediatrics 12/2010; 53(12):1022-5.
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Kwang Nam Kim
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ABSTRACT: The systematic approach to pharmacologic treatment is typically to begin with the safest, simplest, and most conservative measures. It has been realized that the more rapidly inflammation is under control, the less likely it is that there will be permanent sequelae. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the mainstay of initial treatment for inflammation. In addition, the slow-acting antirheumatic drugs (SAARDs) and disease-modifying antirheumatic drugs (DMARDs) have efficacy of anti-inflammatory action in children with chronic arthritis. New therapeutic modalities for inflammation, such as etanercept and infliximab, promise even further improvements in the risk/benefit ratio of treatment. It is not typically possible at the onset of the disease to predict which children will recover and which will go on to have unremitting disease with lingering disability or enter adulthood with serious functional impairment. Therefore, the initial therapeutic approach must be vigorous in all children.
Korean Journal of Pediatrics 11/2010; 53(11):936-41.
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Hye Kyung Cho,
Hyunju Lee,
Jin Han Kang, Kwang Nam Kim,
Dong Soo Kim,
Yun Kyung Kim,
Jung Soo Kim,
Jong-Hyun Kim,
Chang Hwi Kim,
Hwang Min Kim,
Su-Eun Park,
Sung Hee Oh,
Eun Hee Chung,
Sung Ho Cha,
Young Youn Choi,
Jae Kyun Hur,
Young Jin Hong,
Hoan Jong Lee,
Kyung-Hyo Kim
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ABSTRACT: Bacterial meningitis remains a serious cause of morbidity and mortality in childhood, despite the availability of effective vaccines against Haemophilus influenzae type b (Hib) or Streptococcus pneumoniae. The purpose of this study was to analyze data on bacterial meningitis cases in Korea from 1996 through 2005. The information of all hospitalized bacteria-proven meningitis cases was obtained from 17 university hospitals nationwide. A total of 402 cases were identified. Of these, 125 (29.9%) cases were neonates. Streptococcus agalactiae was the most common bacteria responsible for 99 (24.6%) of all cases regardless of age, followed by S. pneumoniae for 91 (22.6%) and H. influenzae for 67 (16.7%) patients. The common etiology beyond the neonatal period was S. pneumoniae for 91 (33.0%) followed by H. influenzae for 63 (22.8%) patients. The overall case fatality rate was 9.4%, which was similar with that in 1986-1995. In conclusion, S. agalactiae, S. pneumoniae and H. influenzae were important etiologic agents of bacterial meningitis in children in the last 10 yrs. It is required to establish the preventive strategy of the three bacteria. The nationwide epidemiologic study should be continued to evaluate immunization strategy and efficacy.
Journal of Korean medical science 06/2010; 25(6):895-9. · 0.84 Impact Factor
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Chang Hwi Kim,
Sung Ho Cha,
Son Moon Shin,
Chun Soo Kim,
Young Youn Choi,
Young Jin Hong,
Myoung Jae Chey, Kwang Nam Kim,
Jae Kyun Hur,
Dae Sun Jo,
Sung Shin Kim,
Sang Lak Lee,
Eun Song Song,
Gunasekaran Ramakrishnan,
Jin Ju Ok,
Olivier Van Der Meeren
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ABSTRACT: Purpose : To compare immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTPa-IPV, InfanrixTM IPV, GlaxoSmithKline Biologicals) with co-administration of commercially available DTPa and IPV vaccines at separate injection sites (DTPa+IPV). Methods : A total of 458 infants aged 8-12 weeks were randomized to receive three-dose primary vaccination at 2, 4 and 6 months with DTPa-IPV or DTPa+IPV. Blood samples were collected pre and post vaccination for measurement of immune responses. Reactogenicity was assessed following each dose using diary cards. Results : One month post-dose 3, seroprotection rates for anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and
3 were ≥99.5% and vaccine response rates to pertussis antigens were at least 98.6% in both DTPa-IPV and DTPa + IPV groups. Non-inferiority between the groups was demonstrated based on pre-defined statistical criteria. Incidences of both local and systemic symptoms were within the same range across both groups with grade 3 symptoms reported following no more than 4.3% of DTPa-IPV doses and 4.5% of DTPa + IPV doses. Two serious adverse events (both pyrexia) after DTPa-IPV administration were considered vaccine-related. Both infants recovered fully. Conclusion : Combined DTPa-IPV vaccine was immunogenic and well tolerated when used as a three-dose primary vaccination course in Korean infants. DTPa-IPV could be incorporated into the Korean vaccination schedule, reducing the number of injections required to complete primary immunization. (Korean J Pediatr Infect Dis 2010;17:156-168)
Korean Journal of Pediatric Infectious Disease. 01/2010; 17:156-168.
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ABSTRACT: Variant Klinefelter syndrome with 48,XXXY/46,XY mosaicism has been rarely reported, and its phenotypic features, compared with those of the classic type, have not been well delineated. We describe a newborn baby with phenotypic abnormalities, including cleft palate and low-set ears. The cytogenetic analysis of peripheral blood lymphocytes showed a karyotype of 48,XXXY[36]/46,XY[4]. To the best of our knowledge, this is the first case in which 48,XXXY/46,XY mosaicism was related to the congenital anomaly of cleft palate. This case underscores that cytogenetic analysis should be a mandatory workup for the patient with cleft palate and that cleft palate may be a rare clinical presentation of the variant Klinefelter syndrome.
The Cleft Palate-Craniofacial Journal 09/2009; 46(5):555-7. · 0.82 Impact Factor
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ABSTRACT: Macrophage activation syndrome (MAS) is a rare and potentially fatal complication of rheumatic disorders in children. We describe a 13-month-old boy in whom MAS developed as a complication of systemic juvenile rheumatoid arthritis (S-JRA). He suffered from fever and generalized rash followed by multiple joints swelling for four months before admission. Physical examination revealed cervical lymphadenopathy and hepatosplenomegaly. Laboratory findings were: abnormal liver enzymes, increased triglyceride and ferritin levels, coagulopathies resembling disseminated intravascular coagulation, anemia and thrombocytopenia. Hyperplasia of hemophagocytic macrophages was remarkable in his bone marrow. Methylprednisolone and cyclosporin therapy resulted in clinical and laboratory improvements. This is the third case of MAS associated with S-JRA in Koreans, and the first one, in which hemophagocytic macrophages were proven in bone marrow.
Journal of Korean Medical Science 09/2005; 20(4):695-8. · 0.99 Impact Factor
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