Clinical significance of antinuclear antibody positivity in patients with severe coronavirus disease 2019

Background/Aims@#This study aimed to investigate the clinical characteristics and outcomes of fluorescent antinuclear antibody (FANA)-positive patients admitted for coronavirus disease 2019 (COVID‐19) and identify FANA as a prognostic factor of mortality. @*Methods@#This retrospective study was conducted at a university-affiliated hospital with 1,048 beds from September 2020 to March 2022. The participants were consecutive patients who required oxygenation through a high-flow nasal cannula, non-invasive or mechanical ventilation, or extracorporeal membrane oxygenation, and conducted the FANA test within 48 hours of admission. @*Results@#A total of 132 patients with severe COVID-19 were included in this study, of which 77 (58.3%) had FANA-positive findings (≥ 1:80). FANA-positive patients were older and had higher inflammatory markers and 28-day mortality than FANA- negative patients. In the multivariate Cox proportional hazard regression analysis, FANA-positive findings (hazard ratio [HR], 2.65; 95% confidence interval [CI], 1.04–6.74), age (per 1-year; HR, 1.05; 95% CI, 1.01–1.10), underlying pulmonary disease (HR, 3.16; 95% CI, 0.97–10.26), underlying hypertension (HR, 2.97; 95% CI, 1.28–6.87), and blood urea nitrogen > 20 mg/dL (HR, 3.72; 95% CI, 1.09–12.64) were independent predictors of 28-day mortality. Remdesivir (HR, 0.34; 95% CI, 0.15–0.74) was found to be an independent predictor that reduced mortality. @*Conclusions@#Our findings revealed an autoimmune phenomenon in patients with severe COVID-19, which provides an ancillary rationale for strategies to optimize immunosuppressive therapy. In particular, this study suggests the potential of FANA to predict the outcomes of COVID-19.

Safety and immunogenicity of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: a phase 1/2, randomized, placebo-controlled, observer-blinded trial

BackgroundVaccination has helped to mitigate the COVID-19 pandemic. Ten traditional and novel vaccines have been listed by the World Health Organization for emergency use. Additional alternative approaches may better address ongoing vaccination globally, where there remains an inequity in vaccine distribution. GBP510 is a recombinant protein vaccine, which consists of self-assembling, two-component nanoparticles displaying the receptor-binding domain (RBD) in a highly immunogenic array. MethodsWe conducted a randomized, placebo-controlled, observer-blinded, phase 1/2 trial to evaluate the safety and immunogenicity of GBP510 (2-doses at a 28-day interval) adjuvanted with or without AS03 in adults aged 19-85 years. The main outcomes included solicited and unsolicited adverse events; anti-SARS-CoV-2 RBD IgG antibody and neutralizing antibody responses; T-cell immune responses. FindingsOf 328 participants who underwent randomization, 327 participants received at least 1 dose of vaccine. Each received either 10 g GBP510 adjuvanted with AS03 (n = 101), 10 g unadjuvanted GBP510 (n = 10), 25 g GBP510 adjuvanted with AS03 (n = 104), 25 g unadjuvanted GBP510 (n = 51), or placebo (n = 61). Most solicited adverse events were mild-to-moderate in severity and transient. Higher reactogenicity was observed in the GBP510 adjuvanted with AS03 groups compared to the non-adjuvanted and placebo groups. Reactogenicity was higher post-dose 2 compared to post-dose 1, particularly for systemic adverse events. The geometric mean concentrations of anti-SARS-CoV-2-RBD IgG antibody reached 2163.6/2599.2 BAU/mL in GBP510 adjuvanted with AS03 recipients (10 g/25 g) by 14 days after the second dose. Two-dose vaccination with 10 g or 25 g GBP510 adjuvanted with AS03 induced high titers of neutralizing antibody via pseudovirus (1369.0/1431.5 IU/mL) and wild-type virus (949.8/861.0 IU/mL) assays. InterpretationGBP510 adjuvanted with AS03 was well tolerated and highly immunogenic. These results support further development of the vaccine candidate, which is currently being evaluated in Phase 3. FundingCoalition for Epidemic Preparedness Innovations RESEARCH IN CONTEXTO_ST_ABSEvidence before this studyC_ST_ABSWe searched PubMed for research articles published by December 31, 2021, using the terms "COVID-19" or "SARS-CoV-2," "vaccine," and "clinical trial." In previously reported randomized clinical trials, we found that mRNA vaccines were more immunogenic than adenovirus-vectored vaccines. Solicited adverse events were more frequent and more severe in intensity after the first dose compared to the second dose for adenovirus-vectored vaccines, whereas they increased after the second dose of mRNA or recombinant spike-protein nanoparticle vaccines. Added value of this studyThis is the first human study evaluating the immunogenicity and safety of recombinant SARS-CoV-2 protein nanoparticle with and without adjuvant AS03, designed to elicit functional cross-protective responses via receptor-binding domain (RBD). Both 10 and 25 g of GBP510 with AS03 formulations were well tolerated with an acceptable safety profile. Potent humoral immune responses against the SARS-CoV-2 RBD were induced and peaked by day 42 (14 days after the second dose). In addition, GBP510 adjuvanted with AS03 elicited a noticeable Th1 response, with production of IFN-{gamma}, TNF-, and IL-2. IL-4 was inconsistent and IL-5 nearly inexistent response across all groups. Implications of the available evidenceThe results from this phase 1/2 trial indicate that GBP510 adjuvanted with AS03 has an acceptable safety profile with no vaccine-related serious adverse events. Two-dose immunization with GBP510 adjuvanted with AS03 induced potent humoral and cellular immune responses against SARS-CoV-2.

A Korean Post-Marketing Surveillance Study of Dolutegravir Single-Agent Tablets in Patients with HIV-1 / 감염과화학요법

Background@#The integrase strand transfer inhibitor dolutegravir has been indicated in Korea since 2014 for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in combination with other antiretroviral agents. This regulatory post-marketing surveillance (PMS) study evaluated the real-life safety and effectiveness of dolutegravir in patients with HIV-1 in clinical practice in Korea. @*Materials and Methods@#This open-label PMS study examined data from consecutive patients (aged ≥12 years) with HIV-1 infection receiving dolutegravir according to locally approved prescribing information; treatment-naïve and treatment-experienced patients were permitted. Data regarding patient demographics, medical history, clinical characteristics, medications (HIV-related and concomitant), and comorbidities were extracted from patient records over a 1-year treatment period. Outcomes included the safety of dolutegravir (primary endpoint) and real-life effectiveness according to the Physician Global Assessment (PGA) and the proportion of patients with plasma HIV-1 RNA count <50 copies/mL at 48 weeks. @*Results@#Of 147 patients treated with dolutegravir at 18 centers in Korea (August 2014 – August 2020), 139 were eligible for the safety analyses and 75 for effectiveness analyses.Patients (mean age 47 years) were mostly male (92.8%) and received dolutegravir in combination with nucleoside reverse transcriptase inhibitor (70.5%) or protease inhibitors (21.6%). Adverse events (AEs) (n = 179 in total) were mostly mild in severity, with the most common being nasopharyngitis (5.0%), dyspepsia (5.0%), pruritus (4.3%), and rash (4.3%).Of 16 adverse drug reactions (ADRs), the most frequent were rash, diarrhea, headache, insomnia, and somnolence (1.4% each). Of 2 serious ADRs, only 1 (gastroenteritis) was unexpected, and both resolved. The risk of experiencing an AE while receiving dolutegravir appeared to be especially increased in patients receiving concomitant medications for other conditions. Dolutegravir effectively suppressed HIV-1 (93.3% of patients had plasma HIV-1 RNA <50 copies/mL), and 100% of patients showed symptom improvement based on physician global assessment. @*Conclusion@#Results of this PMS study showed that dolutegravir administered as highly active antiretroviral therapy was well tolerated and effective in patients with HIV-1 infection.

Oral antiviral clevudine compared with placebo in Korean COVID-19 patients with moderate severity

BackgroundClevudine, an antiviral drug for chronic hepatitis B virus infection, is expected to inhibit the replication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. Therefore, we conducted a prospective, single-blind, proof of concept clinical study to examine the antiviral efficacy and safety of clevudine compared to placebo in Korean corona virus disease 19 (COVID-19) patients with moderate severity. MethodsAdults with confirmed SARS-CoV-2 infection and symptom onset within 7 days were randomized 2:1 to 120 mg clevudine or placebo to receive one of treatments orally once-daily for 14 days. Antiviral efficacy outcomes were the proportion of patients with real-time reverse transcription polymerase chain reaction (RT-PCR) negative result for SARS-CoV-2 infection and cycle threshold (Ct) value changes from baseline. Clinical efficacy outcomes included proportion of patients who showed improvement in lung involvement by imaging tests, proportion of patients with normal body temperature, proportion of patients with normal oxygen saturation, and the changes in C-reactive protein (CRP) from baseline. Safety outcomes included changes in clinical laboratory tests, vital signs measurement, and physical examination from baseline, and incidence of adverse events. ResultsThe proportion of patients with real-time RT-PCR negative test and Ct value changes showed no significant difference between clevudine group and placebo group. The changes in Ct value from baseline were significantly greater in clevudine group compared to placebo group in patients with hypertension, and patients who underwent randomization during the first 5 and 7 days after the onset of symptoms. All clinical efficacy outcomes had no significant difference between clevudine group and placebo group. Clevudine was well tolerated and there was no significant difference in safety profile between two treatment groups. ConclusionsThis is the first clinical study to compare the antiviral efficacy and safety of clevudine to placebo in Korean COVID-19 patients with moderate severity. The study has demonstrated a possible favorable outcome for the reduction of SARS-CoV-2 replication, with acceptable safety profile, when COVID-19 patients were treated with clevudine. Further large-scale clinical studies, preferably with various clinical endpoints and virus titer evaluation, are required to better understand the effectiveness of using clevudine in COVID-19 treatment. Considering recent trend in clinical development for antiviral drugs, we need to design a clinical study aiming for reducing clinical risk of COVID-19 in mild to moderate patients with at least one risk factor for serious illness.

Early Safety Monitoring of COVID-19 Vaccines in Healthcare Workers

Hospital-based surveillance for adverse events was conducted on healthcare workers after they received the first dose of coronavirus disease 2019 (COVID-19) vaccine. Among the two new platform vaccines (messenger RNA- and adenoviral vector-based vaccines), the rates of systemic adverse events were significantly higher among adenovirus-vectored vaccine recipients. Fatigue (87.6% vs. 53.8%), myalgia (80.8% vs. 50.0%), headache (72.0% vs.28.8%), and fever (≥ 38.0°C, 38.7% vs. 0%) were the most common adverse events among adenovirus-vectored vaccine recipients, but most symptoms resolved within 2 days. Both types of COVID-19 vaccines were generally safe, and serious adverse events rarely occurred.

Early Safety Monitoring of COVID-19 Vaccines in Healthcare Workers

Hospital-based surveillance for adverse events was conducted on healthcare workers after they received the first dose of coronavirus disease 2019 (COVID-19) vaccine. Among the two new platform vaccines (messenger RNA- and adenoviral vector-based vaccines), the rates of systemic adverse events were significantly higher among adenovirus-vectored vaccine recipients. Fatigue (87.6% vs. 53.8%), myalgia (80.8% vs. 50.0%), headache (72.0% vs.28.8%), and fever (≥ 38.0°C, 38.7% vs. 0%) were the most common adverse events among adenovirus-vectored vaccine recipients, but most symptoms resolved within 2 days. Both types of COVID-19 vaccines were generally safe, and serious adverse events rarely occurred.

Significance of Decreasing Rate of HIV and HBV Co-infection in a Nationwide Korean HIV/AIDS Cohort

From December 2006 to December 2016, 1093 human immunodeficiency virus (HIV) individuals < 70 years enrolled in Korea human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) cohort were analyzed to investigate the prevalence of HIV/HBV co-infection rate and hepatitis B virus surface antibody (HBsAb) positive rate based on birth year. The HBV co-infection prevalence rate was the highest (8.8%) in patients born between 1960 and 1964 and the lowest (0%) among those born between 1995 and 1999. A decreasing linear trend of HBV co-infection rate was observed according to the 5-year interval changes. HBsAb-positive rate was only 58.1% in our study. The national HBV vaccination programs have effectively lowered the HBV co-infection rate in HIV population. However, it is identified that the HIV population has low HBsAb positive rate. Further evidences supporting efficacy of booster immunization for HBsAb negative HIV patients are required and efforts should be made to increase HBsAb positive rates among HIV patients to prevent horizontal transmission.

Characteristics of Klebsiella pneumoniae Isolates from Stool Samples of Patients with Liver Abscess Caused by Hypervirulent K. pneumoniae

BACKGROUND@#Hypervirulent Klebsiella pneumoniae (hvKP) has been the most significant pathogen for liver abscesses in East Asia including the Republic of Korea (ROK). Although gastrointestinal colonization of K. pneumoniae may cross the intestinal barrier to invade the liver, characteristics of gastrointestinal carriage K. pneumoniae of hvKP liver abscess patients in the ROK are not well known.@*METHODS@#Characteristics of K. pneumoniae isolated from stool samples and liver aspirate samples of patients with hvKP liver abscess at a tertiary care hospital in the ROK between 2017 and 2018 were evaluated.@*RESULTS@#Out of 37 patients with hvKP liver abscess, 11 patients were noted to have K. pneumoniae isolated from stool samples and were enrolled for analysis. The median age was 71 years. For hvKP isolates from the liver aspirate samples, the most common serotype was K1 (72.7%) followed by K2 (27.3%). For K. pneumoniae isolates from the stool sample, the majority was non-K1/K2 serotype (72.7%). Among non-K1/K2 serotype isolates, high variability of sequence type (ST; ST15, ST307, ST37, ST273, ST2622, and ST42) with high rate of presence of extended-spectrum beta-lactamase (100.0%) was noted. The concordance rate of the K. pneumoniae isolates between the liver aspirate samples and the stool samples from the primary hvKP liver abscess was low (27.3%).@*CONCLUSION@#This study suggests that significant heterogeneity of K. pneumoniae colonizing intestinal tract of the hvKP liver abscess patients. Further studies involving a larger number of hvKP liver abscess patients with continuing surveillance are needed to define the changing epidemiology and the role of gastrointestinal K. pneumoniae in the hvKP liver abscess patients in the ROK.

Significance of Decreasing Rate of HIV and HBV Co-infection in a Nationwide Korean HIV/AIDS Cohort

Characteristics of Klebsiella pneumoniae Isolates from Stool Samples of Patients with Liver Abscess Caused by Hypervirulent K. pneumoniae

Significance of Decreasing Rate of HIV and HBV Co-infection in a Nationwide Korean HIV/AIDS Cohort

From December 2006 to December 2016, 1093 human immunodeficiency virus (HIV) individuals < 70 years enrolled in Korea human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) cohort were analyzed to investigate the prevalence of HIV/HBV co-infection rate and hepatitis B virus surface antibody (HBsAb) positive rate based on birth year. The HBV co-infection prevalence rate was the highest (8.8%) in patients born between 1960 and 1964 and the lowest (0%) among those born between 1995 and 1999. A decreasing linear trend of HBV co-infection rate was observed according to the 5-year interval changes. HBsAb-positive rate was only 58.1% in our study. The national HBV vaccination programs have effectively lowered the HBV co-infection rate in HIV population. However, it is identified that the HIV population has low HBsAb positive rate. Further evidences supporting efficacy of booster immunization for HBsAb negative HIV patients are required and efforts should be made to increase HBsAb positive rates among HIV patients to prevent horizontal transmission.

Characteristics of Klebsiella pneumoniae Isolates from Stool Samples of Patients with Liver Abscess Caused by Hypervirulent K. pneumoniae

BACKGROUND@#Hypervirulent Klebsiella pneumoniae (hvKP) has been the most significant pathogen for liver abscesses in East Asia including the Republic of Korea (ROK). Although gastrointestinal colonization of K. pneumoniae may cross the intestinal barrier to invade the liver, characteristics of gastrointestinal carriage K. pneumoniae of hvKP liver abscess patients in the ROK are not well known.@*METHODS@#Characteristics of K. pneumoniae isolated from stool samples and liver aspirate samples of patients with hvKP liver abscess at a tertiary care hospital in the ROK between 2017 and 2018 were evaluated.@*RESULTS@#Out of 37 patients with hvKP liver abscess, 11 patients were noted to have K. pneumoniae isolated from stool samples and were enrolled for analysis. The median age was 71 years. For hvKP isolates from the liver aspirate samples, the most common serotype was K1 (72.7%) followed by K2 (27.3%). For K. pneumoniae isolates from the stool sample, the majority was non-K1/K2 serotype (72.7%). Among non-K1/K2 serotype isolates, high variability of sequence type (ST; ST15, ST307, ST37, ST273, ST2622, and ST42) with high rate of presence of extended-spectrum beta-lactamase (100.0%) was noted. The concordance rate of the K. pneumoniae isolates between the liver aspirate samples and the stool samples from the primary hvKP liver abscess was low (27.3%).@*CONCLUSION@#This study suggests that significant heterogeneity of K. pneumoniae colonizing intestinal tract of the hvKP liver abscess patients. Further studies involving a larger number of hvKP liver abscess patients with continuing surveillance are needed to define the changing epidemiology and the role of gastrointestinal K. pneumoniae in the hvKP liver abscess patients in the ROK.

Korean Registry for Improving Sepsis Survival (KISS): Protocol for a Multicenter Cohort of Adult Patients with Sepsis or Septic Shock / 감염과화학요법

Sepsis is one of the significant causes of morbidity and mortality. The burden caused by sepsis has continued to increase in recent years in the Korea, highlighting the urgent need for the implementation of strategies to improve sepsis treatment outcomes. We therefore designed a web-based sepsis registry system (“Korean Registry for Improving Sepsis Survival” [KISS]) protocol to be used in hospitals in the Korea for evaluation of the epidemiology and clinical characteristics of patients with sepsis, via an analysis of outcome predictors. The inclusion criteria of this registry are as follows: adult patients ≥18 years admitted to the participating hospitals who are diagnosed with sepsis or septic shock. Demographic and clinical information data of the patients will be collected from hospital medical records and will be recorded in a case report form, which will be entered into a web-based data management system. The analysis of the collected data will be performed as follows: (1) epidemiological and clinical characteristics of sepsis and septic shock, (2) application of sepsis bundles and antibiotic stewardship, and (3) audit and feedback. In conclusion, we aim to build the comprehensive web-based sepsis registry in the Korea through a nation-wide network of participating hospitals. Information collected and analyzed through the KISS can be used for further improvements in the clinical management of sepsis. Furthermore, the KISS will facilitate research leading to the formulation of public health policies regarding sepsis bundle and antibiotic stewardship strategies in the Korea.

Trend of Olfactory and Gustatory Dysfunction in COVID-19 Patients in a Quarantine Facility

Background@#Olfactory and gustatory dysfunction has been reported as characteristic symptoms of coronavirus disease 2019 (COVID-19). This study evaluated olfactory and gustatory dysfunction in mild COVID-19 patients using validated assessment methods. @*Methods@#A prospective surveillance study was conducted for mild COVID-19 patients who were isolated at the Gyeonggi International Living and Treatment Support Center (LTSC), Korea.Olfactory function was assessed using the Korean version of the Questionnaire of Olfactory Disorders (QOD) and Cross-Cultural Smell Identification Test (CC-SIT). Gustatory function was assessed using an 11-point Likert scale and 6-n-propylthiouracil, phenylthiocarbamide, and control strips. All patients underwent nasal and oral cavity endoscopic examination. @*Results@#Of the 62 patients at the LTSC, 15 patients (24.2%) complained of olfactory or gustatory dysfunction on admission. Four of 10 patients who underwent functional evaluation did not have general symptoms and 2 were asymptomatic. The mean short version of QOD-negative statements and QOD-visual analogue scale scores were 13 ± 6 and 4.7 ± 3.6, respectively. The mean CC-SIT score was 8 ± 2. No patients showed anatomical abnormalities associated with olfactory dysfunction on endoscopic examination. The mean Likert scale score for function was 8 ± 2, and there were no abnormal lesions in the oral cavity of any patient. @*Conclusions@#The prevalence of olfactory and gustatory dysfunction was 24.2% in mild COVID-19 patients. All patients had hyposmia due to sensorineural olfactory dysfunction, which was confirmed using validated olfactory and gustatory evaluation methods and endoscopic examination. Olfactory and gustatory dysfunction may be characteristic indicators of mild COVID-19.

Infective Endocarditis Presenting as Endogenous Endophthalmitis Secondary to Streptococcus agalactiae in a Healthy Adult: Case Report and Literature Review / 감염과화학요법

Endogenous endophthalmitis secondary to group B Streptococcus (GBS) is extremely rare, particularly in healthy adults. However, the visual prognosis is poor. We report the first South Korean case of GBS infective endocarditis presenting as endogenous endophthalmitis and skin and soft tissue infection. Cultures of blood, vitreous humor, and pus from skin aspirates yielded a penicillin-susceptible serotype V strain of Streptococcus agalactiae. After 6 weeks, the patient completely recovered from GBS infective endocarditis. However, despite early antibiotic treatment and early surgical intervention, the patient's right eye developed phthisis bulbi and was a candidate for evisceration.

Safety and Efficacy of Ziagen (Abacavir Sulfate) in HIV-Infected Korean Patients / 감염과화학요법

BACKGROUND: Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen® (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). MATERIALS AND METHODS: An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea. Subjects older than 18 years taking Ziagen according to prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events after Ziagen administration. Secondary outcomes included the occurrence of adverse drug reactions, occurrence of serious adverse events, and effectiveness of Ziagen administration. RESULTS: A total of 669 patients were enrolled in this study, with a total observation period of 1047.8 person-years. Of these, 90.7% of patients were male. The mean age of patients was 45.8±11.9 years. One-hundred ninety-six (29.3%) patients reported 315 adverse events, and four patients reported seven serious adverse events, without any fatal events. There was one potential case of an abacavir hypersensitivity reaction. Among the 97 adverse drug reactions that were reported from 75 patients, the most frequent adverse drug reactions included diarrhea (12 events), dyspepsia (10 events), and rash (9 events). No ischemic heart disease was observed. In the effectiveness analysis, 91% of patients achieved HIV-1 RNA under 50 copies/mL after 24 months of observation with abacavir administration. CONCLUSION: Our data showed the safety and effectiveness of Ziagen in a real-world setting. During the study period, Ziagen was well-tolerated, with one incident of a clinically suspected abacavir hypersensitivity reaction. The postmarketing surveillance of Ziagen did not highlight any new safety information. These data may be helpful in understanding abacavir and the HIV treatment practices in Korea.

Immunogenicity and Safety of a Live Attenuated Zoster Vaccine (ZOSTAVAX(TM)) in Korean Adults

A live attenuated zoster vaccine (ZOSTAVAX(TM), Merck & Co., Inc.) was approved by the Korea Ministry of Food and Drug Safety in 2009. However, the immunogenicity and safety of the vaccine has not been assessed in Korean population. This is multi-center, open-label, single-arm study performed with 180 healthy Korean adults > or =50 yr of age. The geometric mean titer (GMT) and geometric mean fold rise (GMFR) of varicella zoster virus (VZV) antibodies were measured by glycoprotein enzyme-linked immunosorbent assay (gpELISA) at 4 weeks post-vaccination. Subjects were followed for exposure to varicella or herpes zoster (HZ), the development of any varicella/varicella-like or HZ/HZ-like rashes, and any other clinical adverse experiences (AEs) for 42 days post-vaccination. For the 166 subjects included in the per-protocol population, the GMT at Day 1 was 66.9. At 4 weeks post-vaccination, the GMT for this population was 185.4, with a GMFR of 2.8 (95% CI, 2.5-3.1). Of the 180 subjects vaccinated, 62.8% experienced > or =1 AE, with 53.3% of subjects reporting injection-site AEs. The most frequently reported injection-site AEs were erythema (45.0%) with the majority being mild in intensity. Overall, 44 (24.4%) subjects experienced > or =1 systemic AE, 10 (5.5%) subjects experienced a systemic vaccine-related AE, and 3 (1.7%) subjects experienced > or =1 serious AE not related to vaccine. No subjects reported a VZV-like rash. There was no subject of death and no subject discontinued due to an adverse event. A single dose of zoster vaccine induced VZV-specific gpELISA antibody response and was generally well-tolerated in healthy Korean adults > or =50 yr of age (registry at www.clinicaltrial.gov No. NCT01556451).

A Case of Influenza Associated Fulminant Myocarditis Successfully Treated with Intravenous Peramivir / 감염과화학요법

We report the case of a patient with fulminant myocarditis caused by influenza A virus, who presented with acute-onset heart failure and cardiogenic shock and was treated successfully with single dose of intravenous peramivir and with pharmacologic hemodynamic support. A 45-year-old Korean woman presented to our emergency department (ED) with shortness of breath and an episode of seizure that developed abruptly 5 hours before she arrived in the ED. She had a history of recurrent epileptic seizure 25 years ago, but denied other specific medical illnesses. In the ED, she was hypoxemic (arterial partial pressure of oxygen, 59.8 mmHg on room air) and chest radiography revealed bilateral alveolar infiltrates. A rapid antigen test for influenza A virus was positive, and she was administered a single dose of peramivir (300 mg) intravenously. Five hours later, the patient's dyspnea had worsened and she was hypotensive (blood pressure, 86/53 mmHg), requiring norepinephrine infusion. Further evaluation disclosed an increased cardiac troponin I level of 1.36 ng/mL and a depressed left ventricular ejection fraction of 30%. Under the diagnosis of influenza A-associated myocarditis and cardiogenic shock, she was managed with continuous critical care in the intensive care unit. On day 3, the patient's dyspnea began to resolve and her ventricular function returned to normal. Real-time polymerase chain reaction assays for influenza viruses in serial nasopharyngeal aspirates were positive for influenza A (hH3N2) with a threshold cycle value of 27.39 on day 2, but these became negative by day 4. The patient recovered and was discharged on day 9 after admission. In conclusion, this case indicates that intravenous peramivir might be an effective antiviral agent for the treatment of severe influenza A virus infection.

Perceptions of Tetanus-diphteria-acellular pertussis (Tdap) Vaccination among Korean Women of Childbearing Age / 감염과화학요법

BACKGROUND: The number of cases of pertussis reported has increased gradually in the last decade. Pertussis vaccination is the most effective strategy for the prevention of infection. Despite the fact that young infants are at the highest risk for pertussis, the rate of tetanus-diphtheria-acellular pertussis (Tdap) vaccination is presumed to be very low among women of childbearing age in Korea. The purpose of this study was to investigate the perceptions of women of childbearing age regarding Tdap vaccination in Korea. MATERIALS AND METHODS: Women of childbearing age, who visited the Department of Obstetrics and Gynecology at 3 University hospitals in the Seoul and Gyeonggi-do provinces of Korea, were surveyed. Individual questionnaires were administered from April to May 2012. Demographic data, Tdap vaccination history, general knowledge about pertussis, and information on factors associated with decision on vaccination were collected. RESULTS: Of the 500 reproductive-age women enrolled, only 4 (0.8%) had received the Tdap. The most common reason for non-vaccination was the lack of awareness of pertussis and information about the Tdap. Totally, 171 (34.2%) responded that they would receive a Tdap vaccination in the future. By multivariate analysis, general confidence in the effectiveness of the vaccine (odds ratio [OR] = 1.88, 95% confidence interval [CI] 1.17 to 3.01) was indicated as an important factor for deciding whether to receive the Tdap vaccine (P < 0.01). CONCLUSIONS: The coverage of Tdap vaccination of women of childbearing age, including pregnant women, is very low because of the lack of awareness of pertussis and the Tdap. Education of women of childbearing age about pertussis is very important to increase Tdap vaccination rates among these women, particularly during the perinatal period.

Perception on influenza vaccination in Korean women of childbearing age

PURPOSE: Women who are pregnant, planning to become pregnant in the influenza season or caring for infant 6-59 months of age are identified as priority groups for influenza vaccination. Vaccination rate is presumed to be low in those women. The purpose of this study was to investigate perceptions of childbearing age women about influenza vaccination. MATERIALS AND METHODS: Childbearing age women visiting the department of Obstetrics and Gynecology in 3 University hospitals in Seoul and Gyeonggi-do province were surveyed. Individual interviews were performed to them with questionnaire for 2 months from April to May 2012. Demographic data, Immunization history, general understanding and factors associated with vaccination were asked. RESULTS: Three hundred fifty-five (71.0%) of total 500 reproductive age women had the experience of influenza vaccination. Among 343 women who has been pregnant at least once, 48 women (16.4%) had vaccination during pregnancy, and 46 of them got vaccination since 2009. One hundred ninety women of total 500 women responded that they would get vaccination if pregnant in the next influenza season (38.0%). In multivariate analysis, statistically significant factors associated with plans of influenza vaccination in pregnancy were as follows: experience of childbirth (odds ratio [OR], 1.97; 95% CI, 1.32 to 2.93), high level of education (OR, 1.96; 95% CI, 1.22 to 3.15), previous influenza vaccination (OR, 1.88; 95% CI, 1.17 to 3.01). CONCLUSION: Influenza vaccine coverage on childbearing age women including pregnant women is low because of misperception of vaccination during pregnancy. It is necessary for healthcare provider to correct misunderstanding and to recommend vaccination actively.