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ABSTRACT: This study was designed to assess the immune status of the Korean population against varicella-zoster virus (VZV) through a seroepidemiologic study. Residual blood samples were collected from diagnostic laboratories throughout Korea. Samples were collected in October 2009 to March 2010 from persons 0-79 yr of age and were tested by ELISA (Enzygnost®; Dade Behring, Schwalbach, Germany). Total seroprevalence in subjects 1-79 yr of age was 89.6%. Seroprevalence increased as age increased from 67.3% in subjects 1-4 yr of age to 94.2% in subjects 10-14 yr of age and in subjects over 20 yr of age seroprevalence ranged from 98.0% to 100%. In children under 1 yr of age, passive immunity waned after birth with none of the subjects having antibodies from 7 months of age and over. Among subjects 1-79 yr of age, susceptible subjects to VZV were mainly under 20 yr of age. These results provide information in understanding the dynamics of varicella disease in Korea, which is important in building up strategies for disease control.
Journal of Korean medical science 02/2013; 28(2):195-9. · 0.84 Impact Factor
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ABSTRACT: The World Health Organization (WHO) recommends that all countries adopt Haemophilus influenzae type b (Hib) vaccine into routine child immunization programs to protect children from the significant burden of life-threatening pneumonia and meningitis.
In this blind, comparative, randomized, phase-III Korean multicenter study, we assessed immunogenicity and safety following primary vaccination of a new H. influenzae type b tetanus toxoid conjugate vaccine, LBVH0101 (LG Life Sciences, Ltd., Seoul, Korea) compared with Hiberix™ (GSK, Rixensart, Belgium) in Korean children at 2, 4 and 6 months of age followed by a booster vaccination at 12-15 months. Serum anti-PRP IgG concentration and bactericidal activity were determined. Local/systemic symptoms were assessed after vaccination. Serious adverse events were recorded throughout the study.
A total of 185 infants were included in immunogenicity evaluations. After the second and third doses of LBVH0101, 90.32% and 100% of infants achieved an antibody level ≥1 μg/mL, respectively, compared with 78.26% and 96.74% of those who received Hiberix™. After the second vaccination, the geometric mean concentration (GMC) of LBVH0101 recipients was 7.34 μg/mL and was higher than that of Hiberix™ recipients (3.55 μg/mL). After the third vaccination, the GMCs were 14.59 μg/mL and 12.15 μg/mL in the LBVH0101 and Hiberix™ recipients, respectively. The booster dose produced higher antibody concentrations: 30.25 μg/mL and 71.64 μg/mL for LBVH0101 and Hiberix™ recipients, respectively. Bactericidal capacity and antibody potency of anti-PRP IgG induced by LBVH0101 was 35.05 and 116.27 after the second and third vaccinations, respectively, compared with 53.76 and 79.64 for Hiberix™. Anti-PRP IgG seroprotection rate and GMC were similar post-primary immunization between the groups; both showed functional maturation and similar booster responses. LBVH0101 had comparable safety results as the control vaccine, Hiberix™, as most of the solicited adverse events and unsolicited adverse events upon LBVH0101 administration were mild in severity. No serious vaccination-related adverse reactions were observed.
LBVH0101 showed a good immunogenicity and safety profile in infants and children. The two-dose infant-priming schedule with a booster dose may suffice for Hib immunization in Korean infants (Clinical trial registration numbers: NCT01019772 and NCT01251133).
Vaccine 02/2012; 30(10):1886-94. · 3.77 Impact Factor
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ABSTRACT: Although MMR vaccine is widely used in Korea, there are limited studies on the currently used vaccines. We evaluated the immunogenicity and safety of MMR vaccines in Korean children.
For first and second dose immunization, children aged 12-23 months and 4-6 years were enrolled. All subjects received a single dose of either Priorix™ (Glaxo Smithkline Biologicals, Rixensart, Belgium) or MMRII® (Merck & Co., Inc., West Point, PA, USA). Pre- and postvaccine sera were collected from all participants. Antibody levels were determined by ELISA (Enzygnost®; Dade Behring, Schwalbach, Germany). Safety monitoring included local adverse events for 5 days and systemic adverse events for 42 days following vaccination.
One hundred twenty-one subjects were enrolled in the 12-23 months age group and 39 in the 4-6 years age group. The seroconversion rate in the 12-23 months age group was 97.9-100.0% for measles, 85.1-88.9% for mumps and 100.0% for rubella. All children 4-6 years of age previously seronegative showed seroconversion for measles, mumps and rubella. Local adverse events were reported in 8.3-16.1% (12-23 months age) and 27.8-31.6% (4-6 years age), and 40.0-48.2% (12-23 months age) and 42.1-61.1% (4-6 years age) experienced at least more than 1 systemic adverse reaction. No vaccine-related serious adverse events were reported. Among the same age groups, there was no significant difference in adverse events between the two vaccines.
The MMR vaccines are safe and show good immunogenic responses in children. These data will be invaluable when we introduce diverse vaccines in the following future.
Pediatrics International 06/2011; 53(3):374-80. · 0.63 Impact Factor
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ABSTRACT: This study aimed to assess the immune status of the Korean population against hepatitis A virus (HAV). Residual serum samples from 2008 to 2010 were collected from diagnostic laboratories and a total of 1,872 samples were analyzed. Anti-HAV seroprevalence was 57.3% in subjects aged 1-4 yr, 69.8% at 5-9 yr and decreased to 38.8% at 10-14 yr, 13.0% at 15-19 yr, and 11.7% at 20-29 yr. Seroprevalence increased with increasing age: 52.2% at 30-39 yr, 83.2% at 40-49 yr, 81.4% at 50-59 yr, 93.2% at 60-69 yr, and 95.1% at 70-79 yr. The most susceptible age group consisted of subjects aged 10-29 yr, especially those aged 20-29 yr. This pattern is markedly different from that in the past 3 decades, where the most susceptible group had consisted of children aged less than 10 yr and almost all subjects aged more than 20 yr had developed anti-HAV antibodies. Because of improvements in hygiene and introduction of hepatitis A vaccine, the age demographic of the susceptible population has shifted. These data are important for creating new prevention measures, including vaccination policies, to prevent and control outbreaks of hepatitis A in Korea.
Journal of Korean medical science 06/2011; 26(6):791-6. · 0.84 Impact Factor
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ABSTRACT: To confirm the effect of 7-valent pneumococcal conjugate vaccine (PCV7), pneumococcal nasopharyngeal (NP) carriage was compared between vaccinated (3 + 1 doses PCV7) and non-vaccinated children. Vaccinated subjects were recruited from highly vaccinated regions (≥ 60%), Seoul and Incheon whereas control subjects were recruited from Jeju Island where vaccination rates are low (< 15%). NP swabs were obtained from 400 children aged 18-59 months. Serotype and antibiotic susceptibility was analyzed. Pneumococcal carriage rate was 18.0% (36/200) and 31.5% (63/200) for the vaccinated and control group, respectively. Among those vaccinated, 41.7% (15/36) of the serotypes were vaccine-related type (VRT: 6A, 6C, 19A) with the most common serotype 6C. The next common type was non-typable/non-capsule 30.6% (11/36) followed by non-vaccine type 16.7% (6/36) and vaccine type (VT) serotypes were found in only 11.1% (4/36). In contrast, 52.4% (33/63) of the isolates in the control group were VT. Resistance rates for penicillin and erythromycin were lower in the vaccine group (vaccine vs control; penicillin 45.2% vs 71.4%, erythromycin 74.2% vs 90.5%, P < 0.05). Multi-drug resistance was also lower in vaccinated subjects (vaccine vs control; 45.2% vs 69.8%, P < 0.05). PCV7 reduces carriage in VT which leads to replacement of pneumococci by antibiotic susceptible VRT or non-vaccine type strains.
Journal of Korean medical science 02/2011; 26(2):184-90. · 0.84 Impact Factor
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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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Hye Kyung Cho,
Na Yong Lee, Hyunju Lee,
Hae Soon Kim,
Jeong Wan Seo,
Young Mi Hong,
Seung Joo Lee,
Sun Wha Lee,
Doo Sung Cheon,
Ji Young Hong,
Byung Hak Kang,
Jong-Hyun Kim,
Kyung-Hyo Kim
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ABSTRACT: Hand-foot-mouth disease (HFMD) is a common viral illness in children, which is usually mild and self-limiting. However, in recent epidemics of HFMD in Asia, enterovirus 71 (EV71) has been recognized as a causative agent with severe neurological symptoms with or without cardiopulmonary involvement. HFMD was epidemic in Korea in the spring of 2009. Severe cases with complications including death have been reported. The clinical characteristics in children with neurologic manifestations of EV71 were studied in Ewha Womans University Mokdong Hospital.
Examinations for EV71 were performed from the stools, respiratory secretion or CSF of children who presented neurologic symptoms associated with HFMD by realtime PCR. Clinical and radiologic data of the patients were collected and analyzed.
EV71 was isolated from the stool of 16 patients but not from respiratory secretion or CSF. Among the 16 patients, meningitis (n=10) was the most common manifestation, followed by Guillain-Barré syndrome (n=3), meningoencephalitis (n=2), poliomyelitis-like paralytic disease (n=1), and myoclonus (n=1). Gene analysis showed that most of them were caused by EV71 subgenotype C4a, which was prevalent in China in 2008.
Because EV71 causes severe complications and death in children, a surveillance system to predict upcoming outbreaks should be established and maintained and adequate public health measures are needed to control disease.
Korean Journal of Pediatrics 05/2010; 53(5):639-43.
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ABSTRACT: Streptococcus pneumoniae is a leading cause of morbidity and mortality in the elderly. To prevent invasive pneumococcal diseases, the 23-valent pneumococcal polysaccharide vaccine (PPV) is recommended in subjects over 65 years of age. Although it has been reported to provide approximately 50-80% protection against invasive disease in the general elderly population, there is still controversy as to the effectiveness of the PPV in the elderly.
To evaluate the immune response to the pneumococcal polysaccharide vaccine in the elderly, samples from young adults and elderly were obtained before and one month after vaccination. The quantitative and qualitative response to the vaccine were measured by the ELISA and opsonophagocytic killing assay for eight vaccine type serotypes (4, 6B, 9V, 14, 18C, 19A, 19F, 23F) and one vaccine-related serotype (6A).
The response to the pneumococcal polysaccharide vaccine showed a similar response between adults and elderly when evaluated by the ELISA, however the functional activity of the antibodies elicited after vaccination were lower in the elderly group for more than half of the serotypes evaluated. In comparison of the antibody needed for 1:8 opsonic titer, more antibodies were needed in the elderly for serotypes Pn 4, 19F, 23F and 6A, suggesting the functional activity of antibody detected by the ELISA was lower in the elderly compared with the adult group for these serotypes. As for subjects with an opsonic titer <8 after vaccination, only one subject each for serotypes Pn 4, 9V and 6A were found in the adult group. However, up to 10 (30.3%) of the subjects did not show opsonic activity after vaccination in the elderly group for serotypes Pn 4, 9V, 14, 19A and 6A.
Although the amount of antibodies elicited were similar between the two age groups, distinct differences in function were noted. This report highlights the importance of a quantitative and qualitative evaluation of the immunogenic response to the PPV in the elderly age group.
This trial is registered with Clinical trials.gov. Registration number NCT00964769.
BMC Infectious Diseases 03/2010; 10:60. · 3.12 Impact Factor
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ABSTRACT: A meta-analysis was performed on the immunogenicity of Haemophilus influenzae type b (Hib) conjugate vaccines after 2 (2 and 4 months) and 3 doses (2, 4, and 6 months) in Korean infants. A database search of MEDLINE, KoreaMed, and Korean Medical Database was done. The primary outcome measure was the proportion of infants with anti-polyribosylribitol phosphate (PRP) concentrations > or =1.0 microg/mL. Eight studies including eleven trials were retrieved. One trial reported on the diphtheria toxoid conjugate vaccine (PRP-D) and 2 trials each on the mutant diphtheria toxin (PRP-CRM) and Neisseria meningitidis outer-membrane protein (PRP-OMP) conjugate vaccine. Heterogeneity in study designs between trials on PRP-CRM was noted and one trial reported on a monovalent and another on a combination PRP-OMP vaccine. Thus, a meta-analysis was conducted only on the tetanus toxoid conjugate vaccine (PRP-T). After a primary series of 2 doses and 3 doses, 80.6% (95% confidence interval [CI]; 76.0-85.1%) and 95.7% (95% CI; 94.0-98.0%) of infants achieved an antibody level > or =1.0 microg/mL, respectively. The immunogenic response to the PRP-T vaccine was acceptable after a primary series of 3 doses and also 2 doses. A reduced number of doses as a primary series could be carefully considered in Korean infants.
Journal of Korean medical science 01/2010; 25(1):90-6. · 0.84 Impact Factor
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ABSTRACT: Abstract
Background
Streptococcus pneumoniae is a leading cause of morbidity and mortality in the elderly. To prevent invasive pneumococcal diseases, the 23-valent pneumococcal polysaccharide vaccine (PPV) is recommended in subjects over 65 years of age. Although it has been reported to provide approximately 50-80% protection against invasive disease in the general elderly population, there is still controversy as to the effectiveness of the PPV in the elderly.
Methods
To evaluate the immune response to the pneumococcal polysaccharide vaccine in the elderly, samples from young adults and elderly were obtained before and one month after vaccination. The quantitative and qualitative response to the vaccine were measured by the ELISA and opsonophagocytic killing assay for eight vaccine type serotypes (4, 6B, 9V, 14, 18C, 19A, 19F, 23F) and one vaccine-related serotype (6A).
Results
The response to the pneumococcal polysaccharide vaccine showed a similar response between adults and elderly when evaluated by the ELISA, however the functional activity of the antibodies elicited after vaccination were lower in the elderly group for more than half of the serotypes evaluated. In comparison of the antibody needed for 1:8 opsonic titer, more antibodies were needed in the elderly for serotypes Pn 4, 19F, 23F and 6A, suggesting the functional activity of antibody detected by the ELISA was lower in the elderly compared with the adult group for these serotypes. As for subjects with an opsonic titer <8 after vaccination, only one subject each for serotypes Pn 4, 9V and 6A were found in the adult group. However, up to 10 (30.3%) of the subjects did not show opsonic activity after vaccination in the elderly group for serotypes Pn 4, 9V, 14, 19A and 6A.
Conclusions
Although the amount of antibodies elicited were similar between the two age groups, distinct differences in function were noted. This report highlights the importance of a quantitative and qualitative evaluation of the immunogenic response to the PPV in the elderly age group.
Trial registration
This trial is registered with Clinical trials.gov. Registration number NCT00964769
BMC Infectious Diseases. 01/2010;
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ABSTRACT: The incidence of invasive diseases, including meningitis caused by Haemophilus influenzae type b (Hib) was markedly decreased after routine immunization of Hib vaccine through diverse schedules in many countries. The purpose of this study was to evaluate the immunogenicity and safety of Hib conjugate vaccines in Korean children before the implementation of a national immunization program against Hib in Korea. A multicenter controlled trial was performed on two different Hib vaccines in Korean children. A total of 319 infants were enrolled: 199 infants were immunized with the Hib polysaccharide conjugated to the tetanus toxoid (PRP-T) and 120 infants with the Hib polysaccharide conjugated to the outer-membrane protein of Neisseria meningitides (PRP-OMP). Immunogenicity was evaluated by enzyme-linked immunosorbent assay (ELISA) and serum bactericidal assay. Both vaccines showed good immunologic responses after primary immunization. After 2 doses of PRP-T or PRP-OMP, 78.9% and 91.7% of infants achieved an antibody level of >or=1.0 microg/mL, respectively. Both vaccines were safe and well-tolerated. No serious adverse events were observed. Thus, Hib conjugate vaccines appear to be safe and show good immunogenicity in Korean infants. These results will be important reference data for the implementation of Hib vaccine in the national immunization program of Korea.
Journal of Korean Medical Science 01/2009; 23(6):929-36. · 0.99 Impact Factor
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ABSTRACT: The currently available 7-valent pneumococcal conjugate vaccine (PCV7) elicits good immune response to and is effective against vaccine serotypes. However, its effectiveness against vaccine-related serotypes is variable. Serum samples were obtained 1 month after the last vaccination from 31 infants immunized with PCV7 at 2, 4, and 6 months of age. The sera were used to determine immunoglobulin G antibody levels to eight serotypes (seven vaccine serotypes and serotype 19A) with enzyme-linked immunosorbent assay (ELISA) and opsonic capacity against 11 serotypes (seven vaccine serotypes, serotypes 19A and 6A, and nonvaccine serotypes 5 and 7F) using a multiplexed opsonization assay. ELISA results showed antibody concentrations varied between 1.84 and 10.49 microg/ml, and all subjects had antibody concentrations of >or=0.35 microg/ml for all serotypes, including serotype 19A. In contrast, the opsonic index was detectable (i.e., opsonic index >or= 8) in all children for the seven vaccine serotypes, 81% for serotype 6A, and merely 19% for serotype 19A. PCV7 shows good immunogenicity for vaccine serotypes in infants after a primary series. PCV7 does not elicit opsonic antibodies to serotype 19A. ELISA may thus be an inadequate surrogate assay for evaluating the response for cross-reactive serotypes in infants.
Clinical and vaccine immunology: CVI 01/2009; 16(3):376-81. · 2.37 Impact Factor
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Sung Yoon Cho,
Tae Yeon Kim, Hyunju Lee,
Kyung Hyo Kim,
Eun Sun Yoo,
Hae Soon Kim,
Eun Ae Park,
Kyung Ha Ryu,
Jeong Wan Seo,
Sejung Sohn,
Seung Joo Lee
Korean Journal of Pediatrics 01/2008; 51(10).
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ABSTRACT: This study was conducted to determine the immunogenicity and safety of a 7-valent CRM197 protein conjugated pneumococcal vaccine (PCV7) in Korean infants immunized at 2, 4 and 6 months. A total of 202 infants were enrolled and 146 and 141 infants were, respectively, included in post-2nd dose and post-3rd dose immunogenicity evaluations conducted on a per protocol basis. After two and three PCV7 vaccinations, 63.0-98.0 and 97.2-100% of infants achieved an antibody level of >or=0.35microg/mL, respectively, with a lowest against serotype 6B. No vaccination-related serious adverse reactions were observed. Thus, PCV7 appears safe and highly immunogenic in Korean infants, and adopting two doses for a primary series could be a feasible option for facilitating vaccine coverage rate.
Vaccine 11/2007; 25(45):7858-65. · 3.77 Impact Factor
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ABSTRACT: This study was conducted to determine the immunogenicity and safety of a 7-valent CRM197 protein conjugated pneumococcal vaccine (PCV7) in Korean infants immunized at 2, 4 and 6 months. A total of 202 infants were enrolled and 146 and 141 infants were, respectively, included in post-2nd dose and post-3rd dose immunogenicity evaluations conducted on a per protocol basis. After two and three PCV7 vaccinations, 63.0–98.0 and 97.2–100% of infants achieved an antibody level of ≥0.35μg/mL, respectively, with a lowest against serotype 6B. No vaccination-related serious adverse reactions were observed. Thus, PCV7 appears safe and highly immunogenic in Korean infants, and adopting two doses for a primary series could be a feasible option for facilitating vaccine coverage rate.
Vaccine. 01/2007; 25(45):7858-7865.
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Korean Journal of Pediatrics 01/2007; 50(5).
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ABSTRACT: This study was conducted to determine the immunogenicity and safety of a 7-valent CRM197 protein conjugated pneumococcal vaccine (PCV7) in Korean infants immunized at 2, 4 and 6 months. A total of 202 infants were enrolled and 146 and 141 infants were, respectively, included in post-2nd dose and post-3rd dose immunogenicity evaluations conducted on a per protocol basis. After two and three PCV7 vaccinations, 63.0–98.0 and 97.2–100% of infants achieved an antibody level of ≥0.35 μg/mL, respectively, with a lowest against serotype 6B. No vaccination-related serious adverse reactions were observed. Thus, PCV7 appears safe and highly immunogenic in Korean infants, and adopting two doses for a primary series could be a feasible option for facilitating vaccine coverage rate.
Vaccine.
