Review of Measles in Korea: Quarantine and Elimination / 감염과화학요법

Strong policies were established to maintain vaccination rate at ≥95% to expedite the eradication and elimination of measles outbreaks; nationwide survey of measles immunity to determine the susceptibility and the mandatory submission of second measles vaccination records when entering primary school. The measles control policies were also implemented to help achieve the goal of eliminating measles after the catch-up vaccination and they can be summarized as strategies for classifying measles patients based on their clinical symptoms while anticipating that weaker symptoms than those in typical cases would be seen; improving the operation of laboratories to world-class level for diagnosis of measles and identification of epidemiological circumstances for strengthen the detection of patients suspected of having measles; and immediate response through a rapid reporting system. With these efforts, Korea became the country to make the declaration of measles elimination by complying with all standards presented by the World Health Organization in 2006, re-verified in 2014. However, sporadic outbreaks of measles have repeatedly occurred even after the declaration of measles elimination. This indicates the need for continued control of imported cases and possible re-outbreaks. Also, it will be necessary to find and implement measures to continuously maintain the policy.

Deep Neck Inflammation: Probable Kawasaki Disease in Korean Children

Objectives@#. Deep neck infections (DNIs) can cause life-threatening complications, and prompt diagnosis and management are necessary. Kawasaki disease (KD) may be accompanied by deep neck inflammation; making it difficult to distinguish from DNIs. This study was performed to evaluate clinical features and outcomes of children with parapharyngeal and retropharyngeal inflammation. @*Methods@#. Medical records of the children diagnosed with parapharyngeal and retropharyngeal cellulitis or abscess using cervical computed tomography (CT) between 2013 and 2017 were retrospectively reviewed. @*Results@#. A total of 47 children were diagnosed with parapharyngeal and retropharyngeal inflammation. Eleven (23.4%) of them were eventually diagnosed with KD, and 36 (76.6%) were diagnosed with DNIs. There were no significantly different clinical and laboratory characteristics on admission between children diagnosed with KD and DNIs; however, significantly more children with KD were febrile for ≥3 days after admission compared to those with DNIs (P=0.009). Deep neck abscesses on CT were observed in 16 children with DNIs (44.4%) and in no child with KD (P=0.009). Among the 36 children with DNIs, 30 (83.3%) were cured with antibiotic therapy only. @*Conclusion@#. A quarter of children presenting with deep neck inflammation were diagnosed with KD. KD should be considered in children showing deep neck inflammation unresponsive to empirical antibiotic therapy after 3 days, especially in those presenting with deep neck cellulitis rather than deep neck abscess.

The Measles Strikes Back

No abstract available.

Development and implementation of standardized method for detecting immunogenicity of acellular pertussis vaccines in Korea

PURPOSE: There is no standard method for confirming the immunogenicity of acellular pertussis vaccines. We tried to develop a local standard method for evaluating the immunogenicity of the three-component of acellular pertussis vaccines which was developed by a Korean local company. MATERIALS AND METHODS: The developed pertussis antigens (pertussis toxin, filamentous hemagglutinin, pertactin) were evaluated by in-house enzyme-linked immunosorbent assay (ELISA) using 189 negative sera, 25 positive sera, and 73 paired sera (pre- and post-Tdap [tetanus, diphtheria, and acellular pertussis] vaccinated sera). ELISA units were calculated by the reference line method, compared with World Health Organization reference sera, and the cut-off value was calculated using negative sera. RESULTS: When compared to National Institute for Biological Standards and Control control antigen (NIBSC) control antigens, the developed pertussis toxin (PT) and filamentous haemagglutinin (FHA) antigens were 203.48 and 61.60 IU/µg, respectively. Each in-house ELISA was established by validating the coefficients of variation % (PT, 11.53%; FHA, 8.60%; pertactin [PRN], 9.86%) obtained from the results of inter- and intra-assay variation. Also, the cut-off values of PT, FHA, and PRN were 11.65, 38.95, and 5.66 EU/mL, respectively. The distributions of antibody levels in paired showed that 93.15% (68/73) in anti-PT IgG, 97.26% (72/73) in anti-FHA IgG, and 100% in anti-PRN IgG were higher than a 100% increase after vaccination. Additionally, the values of 89.04% (65/73) in anti-PT IgG, 97.26% (72/73) in anti-FHA IgG, and 100% in anti-PRN IgG were below each cut-off point. CONCLUSION: We established an in-house ELISA method using self-developed antigens, and these immunoassays have provided a way to standardize measuring the immunogenicity of newly developed vaccines, through single- and dual-serology.

Clinical Features of Staphylococcal Scalded Skin Syndrome Caused by Community-Associated Methicillin-Resistant Staphylococcus aureus in Changwon City, Korea, during 2006 and 2015

PURPOSE: We investigated the clinical features and epidemiology of staphylococcal scalded skin syndrome (SSSS) from year 2006 to 2015 in Changwon city, Korea. METHODS: We reviewed medical records of 69 patients diagnosed with SSSS from year 2006 to 2015. Antibiotic susceptibility testing was performed by agar dilution method. Methicillin-resistant Staphylococcus aureus (MRSA) was phenotypically identified by oxacillin susceptibility testing and genotypically confirmed by the existence of the mecA gene. RESULTS: The median age of patients was 2.0 years (range 0.2–6 years). Three (4.3%), 53 (76.8%), and 13 (18.9%) patients showed the generalized type, the intermediate type, and the abortive type, respectively. Patients occurred throughout the year, but most patients occurred between July and October. MRSA was isolated from 54 of the 60 patients regardless of the clinical types. All patients recovered without any complications. CONCLUSIONS: There was a constant occurrence of SSSS patients caused by MRSA in Changwon area during 2006 and 2015. It is needed to constantly monitor the occurrence of patients with SSSS.

A clinico-epidemiological multicenter study of herpes zoster in immunocompetent and immunocompromised hospitalized children

PURPOSE: There are limited population-based data regarding herpes zoster in children. Thus we conducted a multi-institutional epidemiological analysis of herpes zoster in children and comparative analysis according to their immune status. MATERIALS AND METHODS: The study included 126 children under the age of 18 years who were hospitalized for herpes zoster at 8 hospitals in South Korea, between July 2009 and June 2015. The subjects were divided into 2 groups according to their immune status, and medical records were reviewed. RESULTS: There were 61 cases (48.4%) in the immunocompetent group and 65 cases (51.6%) in the immunocompromised group. Median age was older in immunocompromised group (11.4 vs. 8.6) (p<0.001). The mean duration of hospitalization was longer in immunocompromised group (11.0 vs. 6.6) (p<0.001). Patients were treated with oral or intravenous antiviral agents. A total of 12 in immunocompetent group were cured only by oral acyclovir. No treatment failure was found in both groups. Six immunocompromised patients had postherpetic neuralgia and 1 case was in immunocompetent group. In immunocompetent children, herpes zoster was likely caused by early varicella infection. There was no increase in progression of severity in both groups due to appropriate treatment. CONCLUSION: Early initiation of therapy is necessary for those in immunocompromised conditions. And inactivated herpes zoster vaccination may be considered in immunocompromised adolescents in the future.

A Boy with Chronic Active EBV Infection Presented as Mosquito Bite Hypersensitivity Progressed to Fatal Hemophagocytic Lymphohistiocytosis due to NK Cell Neoplasm / 임상소아혈액종양

Chronic active Epstein-Barr virus (CAEBV) infection is characterized by recurrent infectious mononucleosis (IM)-like symptoms and an unusual pattern of anti-EBV antibodies. We report a boy with CAEBV who progressed to aggressive hemophagocytic lymphohistiocytosis (HLH) with NK cell neoplasm. A 19-year-old adolescent boy was admitted with fever and a history of recurrent IM-like symptoms following mosquito bites since the age of 6 years. His condition was diagnosed as CAEBV with atypical lymphocytosis and an unusual pattern of anti-EBV antibodies. His symptoms subsided during treatment with steroids and cyclosporine, although the EBV genome load kept increasing for several years. He was re-admitted after follow-up loss for 8 years, and his clinical and laboratory findings confirmed HLH and high titer of the EBV genome. Bone marrow analysis with flow cytometry showed hemophagocytosis with compatible NK cell neoplasm. He rapidly progressed to pulmonary infection and expired soon after. We conclude that hematopoietic stem cell transplantation may be a potential therapeutic modality for treating CAEBV before serious EBV manifestations.

Seroprevalence of Hepatitis A Virus in Pediatric Patients with Hematologic Malignancies after Chemotherapy and Hematopoietic Cell Transplantation / 감염과화학요법

This retrospective study was performed to determine the seroprevalence of hepatitis A virus (HAV) in children and adolescents with hematologic malignancies after the completion of chemotherapy and hematopoietic cell transplantation (HCT). Of 97 enrolled patients, 60 (61.9%) were seropositive for HAV. The seroprevalences in patients undergoing chemotherapy and HCT were 60.3% (41/68) and 65.5% (19/29), respectively (P = 0.628). No significant factors associated with seropositivity for HAV after chemotherapy and HCT were identified. Anti-HAV tests and HAV re-vaccinations can be considered in children and adolescents with underlying hematologic malignancies after chemotherapy and HCT based on the anti-HAV results.

Enzyme-linked immunosorbent assay for detecting anti-pertussis toxin antibody in mouse

PURPOSE: Although the DTaP and Tdap vaccines used to prevent pertussis have been used for a long time, there is no standard method for measuring pertussis antigens. Therefore, this preliminary study was conducted to develop an enzyme-linked immunosorbent assay method using an animal model for measuring antibodies against pertussis toxin, the most important pertussis pathogenic antigen, in the sera of vaccinated mice. MATERIALS AND METHODS: Bordetella pertussis Tohama phase I was cultured for 24–30 hours, and then pertussis toxin was purified from the culture medium by chromatography. Purified pertussis toxin was diluted in phosphate-buffered saline-coating buffer, and 100 µL of diluted pertussis toxin was added to each well and reacted at room temperature for 4 hours. Positive serum was diluted to 1/1,250–1/80,000 and negative serum was diluted to 1/50 to determine the coating concentration with the optimal signal/noise ratio. Optimal test conditions were confirmed from the dilution factors of the secondary antibody and streptavidin horseradish peroxidase (SA-HRP). RESULTS: Optimal conditions were as follows: 4 µg/mL for coating antigen; 1/40,000 for secondary antibody; and 1/1,000 for the SA-HRP dilution factor. Comparison of the sera obtained from mice treated with a developing vaccine and commercial vaccine with National Institute for Biological Standard and Control standard serum under the established conditions showed the following results: 1,300.62, 534.94, and 34.85, respectively. CONCLUSION: The method developed in this study is suitable for measuring anti-pertussis toxin antibodies and may be applicable for clinical sample analysis or indirect diagnosis of pertussis.

A Phase III Study to Evaluate the Immunogenicity and Safety of GC1107 (Adult Tetanus Diphtheria Vaccine) in Healthy Adults

BACKGROUND: This study was conducted to assess the immunogenicity and safety of GC1107 (adult tetanus diphtheria [Td] vaccine). The primary goal was to evaluate the non-inferiority of the immunogenicity of GC1107 compared to the control vaccine. Additionally, the safety profiles of GC1107 and the control vaccine were compared. METHODS: The subjects were adults ≥ 18 years old who were not injected with Td or adult tetanus-diphtheria-pertussis (TdaP) vaccine within the recent 5 years. A total of 253 subjects were enrolled and randomized to either the GC1107 group or the control group. For immunogenicity assessment, blood samples were collected at baseline and 28 days after vaccination and antibody titer of diphtheria and tetanus were assessed. RESULTS: The seroprotection rates of diphtheria and tetanus were 89.76% and 91.34%, respectively, in the GC1107 group, and 87.80% and 86.99% in the control group. The geometric mean titer (GMT) of the anti-diphtheria antibody increased after vaccination in both groups, showing no significant difference between the groups (P = 0.139). The anti-tetanus GMTs after vaccination also showed comparable increases in both groups, and showed no significant difference (P = 0.860). In the safety evaluation, solicited local adverse reactions occurred in 81.2% of the subjects in the GC1107 group and in 86.4% of the subjects in the control group. Solicited systemic adverse events occurred in 33.2% of the subjects in the GC1107 group and in 47.2% of the subjects in the control group, which did not reach statistical significance. CONCLUSION: This phase III study demonstrated non-inferiority in immunogenicity and comparable safety of GC1107 compared with the control Td vaccine. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02361866

Erratum: Addition of a Co-Author: Etiology of Invasive Bacterial Infections in Immunocompetent Children in Korea (2006–2010): a Retrospective Multicenter Study

The authors regret that one co-author (Kyung-Hyo Kim) was missing in the article.

Safety and Immunogenicity of an Egg-Cultivated Quadrivalent Inactivated Split-virion Influenza Vaccine (GC3110A) in Healthy Korean Children: a Randomized, Double-blinded, Active-controlled Phase III Study

BACKGROUND: The frequency with which the 2 B lineages have been found to cocirculate in a season has been on the rise, which has spurred the need for a quadrivalent influenza vaccine (QIV) to protect against both B lineages. The World Health Organization (WHO) recommended that QIV include both B lineages beginning in the 2013–2014 flu season. This study was conducted to evaluate the immunogenicity and safety of an egg-cultivated QIV in healthy Korean children and adolescents aged ≥ 6 months to < 19 years. METHODS: A total of 528 subjects were randomized 4:1 to receive either a QIV (GC3110A) or a trivalent influenza vaccine. Hemagglutination inhibition antibody responses were assessed 28 days after the last dose. Safety was also evaluated. RESULTS: The proportion of subjects in the GC3110A group who achieved seroconversion was confirmed to exceed 40% across all age groups. The proportion of subjects aged ≥ 6 months to < 3 years in the GC3110A group who achieved seroprotection failed to meet the Ministry of Food and Drug Safety (MFDS) standard of 70%. Potential causes may include the small number of subjects, as well as the small dosage. However, results pertaining to the other age groups satisfied the MFDS standard. The safety profile was also comparable to that of the control. CONCLUSION: The new quadrivalent split influenza vaccine may offer broader protection to children and adolescents aged ≥ 3 years to < 19 years of age against both influenza B lineages than the existing trivalent influenza vaccines (Registered at the ClinicalTrials.gov NCT02541253).

Etiology of Invasive Bacterial Infections in Immunocompetent Children in Korea (2006–2010): a Retrospective Multicenter Study

BACKGROUND: Invasive bacterial infections in apparently immunocompetent children were retrospectively analyzed to figure causative bacterial organisms in Korea. METHODS: A total of 947 cases from 25 university hospitals were identified from 2006 to 2010 as a continuance of a previous 10-year period study from 1996 to 2005. RESULTS: Escherichia coli (41.3%), Streptococcus agalactiae (27.7%), and Staphylococcus aureus (27.1%) were the most common pathogens in infants < 3 months of age. S. agalactiae was the most prevalent cause of meningitis and pneumonia and E. coli was the major cause of bacteremia without localizing signs in this group. In children 3 to 59 months of age, Streptococcus pneumoniae (54.2%), S. aureus (20.5%), and Salmonella spp. (14.4%) were the most common pathogens. S. pneumoniae was the leading cause of pneumonia (86.0%), meningitis (65.0%), and bacteremia without localizing signs (49.0%) in this group. In children ≥ 5 years of age, S. aureus (62.8%) was the predominant pathogen, followed by Salmonella species (12.4%) and S. pneumoniae (11.5%). Salmonella species (43.0%) was the most common cause of bacteremia without localizing signs in this group. The relative proportion of S. aureus increased significantly over the 15-year period (1996–2010) in children ≥ 3 months of age (P < 0.001), while that of Haemophilus influenzae decreased significantly in both < 3 months of age group (P = 0.036) and ≥ 3 months of age groups (P < 0.001). CONCLUSION: S. agalactiae, E. coli, S. pneumoniae, and S. aureus are common etiologic agents of invasive bacterial infections in Korean children.

Clinical Characteristics of Pertussis Epidemic in Changwon

PURPOSE: Pertussis can be prevented with a vaccine. Despite this, there have been an increasing number of cases worldwide, and also in Korea. This study aimed to investigate the epidemiology and clinical characteristics of the recent outbreak in the Changwon area. METHODS: Patients who visited Changwon Fatima Hospital from July 2015 to March 2016 with respiratory symptoms, including spasmodic cough, cough induced vomiting, inspiratory ‘intake’ sound (whooping), and a night-time cough for >1 week were included in this study. Respiratory specimens were collected from patients and a polymerase chain reaction (PCR) and detected anti-pertussis immunoglobulin G enzyme-linked immunosorbent assay kit test were performed. Patients with underlying diseases, or those who had received a DTaP or Tdap vaccination in recent 1 year were excluded. RESULTS: Pertussis was diagnosed in 37 of 50 patients, two patients were positive according to the PCR, and 37 patients were positive according to serologic tests. The age distribution of the patients was 1 month to 15 years. After administering antibiotics, all patients recovered without complications. CONCLUSIONS: A pertussis outbreak occurred in Changwon in 2015 and 2016. This data can provide the basis for further study on the epidemiology of pertussis in Korea.

Clinical Comparison of Influenza A and B Virus Infection in Hospitalized Children

PURPOSE: The objective of this study was to compare the clinical characteristics of influenza A and B infections and analyze the effect of oseltamivir in hospitalized children. METHODS: We investigated children under the age of 15, who were diagnosed with influenza A/H1N1, A/H3N2, or B from January to April 2014. The subjects were admitted to the Changwon Fatima Hospital and diagnosed using a rapid antigen test from nasopharyngeal swabs. The medical records of the patients were retrospectively reviewed. RESULTS: A total of 302 pediatric patients with influenza were enrolled. Influenza B infection was the most common type (n=187, 61.9%), followed by A/H3N2 (n=100, 33.1%) and A/H1N1 (n=15, 5.0%). Compared to patients diagnosed with influenza A, patients diagnosed with influenza B were older (P=0.005), and the duration of fever was significantly longer (P=0.001). A total of 161 patients (53.3%) had been vaccinated against influenza during the season, before admission. Among the patients infected with A/H3N2 and B, the duration of fever was shorter in oseltamivir recipients compared to oseltamivir non-recipients (P=0.026 and P=0.004, respectively). CONCLUSIONS: There were significant differences between influenza A and B groups in terms of age, demographics, and clinical course. Although the effectiveness of oseltamivir on influenza differs according to the type of influenza, our data provides evidence that oseltamivir is beneficial for both A and B infections.

Community-acquired Escherichia coli Enteritis in Korean Children: The Clinical Application of a Stool Polymerase Chain Reaction Assay / 감염과화학요법

BACKGROUND: Although Escherichia coli is a common cause of bacterial enteritis in Korea, reports on community-acquired E. coli enteritis in Korean children are scarce. This study aimed to determine the clinical characteristics and pathotype distribution of community-acquired E. coli enteritis diagnosed by a multiplex polymerase chain reaction (PCR) assay in Korean children. MATERIALS AND METHODS: The medical records of children aged 18 years or less who were diagnosed with acute gastroenteritis by the attending physician between 2013 and 2016 were retrospectively reviewed. The clinical characteristics of children diagnosed with E. coli enteritis were investigated and compared with those diagnosed with Salmonella enteritis. E. coli and Salmonella infections were diagnosed by a stool PCR assay. RESULTS: Among 279 children, in whom PCR assays for E. coli and Salmonella spp. were performed, Salmonella enteritis and E. coli enteritis were diagnosed in 43 (15.4%) and 39 (14.0%) children, respectively. Among the 39 children with E. coli enteritis, enteropathogenic E. coli (n=21, 53.8%) and enteroaggregative E. coli (n=15, 38.4%) were the most common causative agents. Empirical antibiotics were administered to 33 (84.6%) children. A total of 31 (79.5%) children developed fever, and 25 (80.6%) of them had the fever for 3 days or less, which resolved a median of 1 day (range 0-3 days) after hospitalization. The most frequent gastrointestinal symptom was diarrhea (n=36, 92.3%). Significantly more children with E. coli enteritis were aged 2 years or less as compared with those with Salmonella enteritis (41.0% vs. 21.9%, P = 0.021). Children with Salmonella enteritis more frequently complained of fever (97.7% vs. 79.5%, P = 0.012), abdominal pain (90.7% vs. 64.1%, P = 0.004), and hematochezia (46.5% vs. 10.3%, P < 0.001) than those with E. coli enteritis. Erythrocyte sedimentation rate and C-reactive protein levels were significantly higher in children with Salmonella enteritis than those with E. coli enteritis (P < 0.001). CONCLUSION: Enteropathogenic E. coli was the most frequent pathotype in Korean children with E. coli enteritis that caused mild clinical symptoms. A stool PCR assay for E. coli may be useful for epidemiological purpose and for an early diagnosis of E. coli enteritis.

Clinical Impact of Mixed Respiratory Viral Infection in Children with Adenoviral Infection / 감염과화학요법

BACKGROUND: Although adenovirus (ADV) infection occurs steadily all year round in Korea and the identification of respiratory viral coinfections has been increasing following the introduction of multiplex real-time polymerase chain reaction tests, the clinical impact of viral coinfection in children with ADV infection has rarely been reported. MATERIALS AND METHODS: Medical records of children diagnosed with ADV infection were retrospectively reviewed. The enrolled children were divided into two groups based on the identified respiratory viruses: ADV group and coinfection group. Clinical and laboratory parameters were compared between the two groups. RESULTS: In total, 105 children (60 males and 45 females) with a median age of 29 months (range: 0-131 months) diagnosed with an ADV infection were enrolled. Fever (99.0%) was by far the most frequent symptom, followed by respiratory (82.9%), and gastrointestinal (22.9%) symptoms. Upper and lower respiratory tract infections were diagnosed in 56 (53.3%), and 32 (30.5%) children, respectively. Five (4.8%) children received oxygen therapy, and no child died due to ADV infection. Coinfection was diagnosed in 32 (30.5%) children, with rhinovirus (46.9%), and respiratory syncytial virus (21.9%) being the most frequent. The proportions of children younger than 24 months (P <0.001), with underlying medical conditions (P = 0.020), and diagnosed with lower respiratory tract infection (P = 0.011) were significantly higher in the coinfection group than in the ADV group. In a multivariate analysis, only the younger age was significantly associated with coinfection (P <0.001). Although more children in the coinfection group received oxygen therapy (P = 0.029), the duration of fever and hospitalization was not significantly different between the two groups. CONCLUSION: Respiratory viral coinfection with ADV occurred more frequently in children younger than 24 months of age compared with children aged 24 months or older. Respiratory viral coinfection may increase the severity of ADV infection, however, appropriate therapy prevented prolonged hospitalization and poor prognosis due to coinfection.

Etiology of Acute Pharyngotonsillitis in Children: The Presence of Viruses and Bacteria

PURPOSE: The purpose of this study was to investigate the etiology of acute pharygotonsillitis in pediatric patients. METHODS: Pharyngeal swabs from patients with acute pharyngotonsillitis were evaluated for viruses and bacterial organisms from March 2010 through March 2011. RESULTS: Of 615 patients, potentially pathogenic bacteria were isolated in 40 (6.5%), viruses were isolated in 310 (50.4%), and no pathogens were isolated in 267 patients (43.4%). Both viral and bacterial pathogens were found in 2 (0.3%). Of 40 patients with bacterial pathogens, group A streptococci were found in 31 (77.5%). Among 310 patients with virus infection, adenovirus was the most frequently recovered (203 patients; 65.5%), followed by rhinovirus (65 patients; 21.0%), enterovirus (43 patients; 13.9%) and coronavirus (18 patients; 5.8%). There were 25 patients who had been coinfected with 2 viruses. In viral pharyngotonsillitis, cough, rhinorrhea, conjunctivitis and diarrhea were prominent. On the other hand, pharyngeal injection and pharyngeal petechiae were prominent in bacterial pharyngotonsillitis. CONCLUSIONS: Virus infection was a big part of acute pharyngotonsillitis and there were differences in clinical manifestations among viral and bacterial infections. Therefore, we need to distinguish between virus infection and bacterial infection using clinical signs for preventing the abuse of antibiotics.

Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial

PURPOSE: A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea. MATERIALS AND METHODS: The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers were excluded in a screening step. Immune response was measured by a hemagglutination inhibition (HI) assay. RESULTS: The seroprotection rates against A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2009 were 74.42% [95% confidence interval (CI): 61.38–87.46], 72.09% (95% CI: 58.69–85.50), and 86.05% (95% CI: 75.69–96.40), respectively. Calculated seroconversion rates were 74.42% (95% CI: 61.38–87.46), 74.42% (95% CI: 61.38–87.46), and 79.07% (95% CI: 66.91–91.23), respectively. There were 25 episodes of solicited local adverse events in 21 subjects (47.73%), 21 episodes of solicited general adverse events in 16 subjects (36.36%) and 5 episodes of unsolicited adverse events in 5 subjects (11.36%). All adverse events were grade 1 or 2 and disappeared within three days. CONCLUSION: The immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial.

A Survey of Serum Bactericidal Antibodies against Neisseria meningitidis Serogroups A, C, W and Y in Adolescents and Adults in the Republic of Korea / 감염과화학요법

BACKGROUND: This descriptive epidemiological study aimed to assess the prevalence of serum bactericidal antibodies against Neisseria meningitidis serogroups A, C, W and Y in adolescents and adults in the Republic of Korea. MATERIALS AND METHODS: In total, 987 subjects aged 11-55 years from five geographical regions of Korea were included in the study. Human serum bactericidal assay (hSBA) was used to measure hSBA titres for serogroups A, C, W and Y. Percentages of subjects with hSBA titres ≥4 and ≥8, geometric mean titres (GMTs), and associated 95% confidence intervals (CIs), were estimated. Analysis was performed for the entire study population and stratified by age group or region. No statistical hypotheses were tested. RESULTS: The highest percentage of subjects with hSBA titres ≥8 was observed for serogroup W (74%), was similar for serogroups C (34%) and Y (36%), and was lowest for serogroup A (9%). The percentages of subjects with hSBA titres ≥4 were similar to those with hSBA titres ≥8 for all serogroups. GMTs were 2.56 µg/mL (serogroup A), 5.14 µg/mL (serogroup C), 22.63 µg/mL (serogroup W) and 5.28 µg/mL (serogroup Y). Similar trends in GMTs across serogroups were seen for individual regions and age groups. The highest GMTs for serogroups A, W and Y were recorded in the >19-29 years group, and for serogroup C in the >49-55 years group. Across all regions, GMTs were very similar for serogroups A, C and Y, while more variation was seen for serogroup W. CONCLUSION: In the Korean population, among Neisseria meningitidis serogroups A, C, W and Y, serum bactericidal antibodies were most prevalent against serogroup W and least prevalent against serogroup A. These trends were maintained across age groups and regions. The highest GMTs for serogroups A, W and Y were observed in the >19-29 years group. The reasons behind the observed differences in prevalence of bactericidal antibodies against the serogroups are currently not understood, although carriage and cross-reactivity of the assay may be important influences.