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1.
Front Immunol ; 15: 1382944, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38803497

RESUMO

As coronavirus disease-2019 (COVID-19) becomes an endemic disease, the virus continues to evolve and become immunologically distinct from previous strains. Immune imprinting has raised concerns about bivalent mRNA vaccines containing both ancestral virus and Omicron variant. To increase efficacy against the predominant strains as of the second half of 2023, the updated vaccine formulation contained only the mRNA of XBB.1.5 sublineage. We conducted a multicenter, test-negative, case-control study to estimate XBB.1.5 monovalent vaccine effectiveness (VE) and present the results of an interim analysis with data collected in November 2023. Patients who underwent COVID-19 testing at eight university hospitals were included and matched based on age (19-49, 50-64, and ≥65 years) and sex in a 1:1 ratio. VE was calculated using the adjusted odds ratio derived from multivariable logistic regression. Of the 992 patients included, 49 (5.3%) received the XBB.1.5 monovalent vaccine at least 7 days before COVID-19 testing. Patients with COVID-19 (cases) were less likely to have received the XBB.1.5 monovalent vaccine (case 3.5% vs. control 7.2%, p=0.019) and to have a history of COVID-19 within 6 months (2.2% vs. 4.6%, p=0.068). In contrast, patients with COVID-19 were more likely to be healthcare workers (8.2% vs. 3.0%, p=0.001) and to have chronic neurological diseases (16.7% vs. 11.9%, p=0.048). The adjusted VE of the XBB.1.5 monovalent mRNA vaccine was 56.8% (95% confidence interval: 18.7-77.9%). XBB.1.5 monovalent mRNA vaccine provided significant protection against COVID-19 in the first one to two months after vaccination.


Assuntos
Vacinas contra COVID-19 , COVID-19 , SARS-CoV-2 , Eficácia de Vacinas , Humanos , COVID-19/prevenção & controle , COVID-19/imunologia , COVID-19/virologia , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Idoso , Vacinas contra COVID-19/imunologia , Vacinas contra COVID-19/administração & dosagem , SARS-CoV-2/imunologia , SARS-CoV-2/genética , Estudos de Casos e Controles , República da Coreia/epidemiologia , Vacinas de mRNA , Adulto Jovem , Vacinas Sintéticas/imunologia
2.
J Korean Med Sci ; 39(15): e146, 2024 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-38651226

RESUMO

In the 2023-2024 season, the influenza epidemic in South Korea peaked earlier than in recent years. In this study, we aimed to estimate the interim vaccine effectiveness (VE) of the influenza vaccination to prevent influenza during the early season. From November 1, 2023, to December 31, 2023, we enrolled 2,632 subjects with influenza-like illness from eight hospitals participating in hospital-based influenza morbidity and mortality surveillance. A retrospective test-negative case-control study was conducted to estimate the VE. The results showed an adjusted VE of 22.5% (95% confidence interval [CI], 6.6 to 35.8) for the total population. The adjusted VE was 22.3% (95% CI, 6.1 to 35.7) for influenza A and 9.4% (95% CI, -51.3 to 45.7) for influenza A/H1N1. Full results of the analysis will be reported.


Assuntos
Vacinas contra Influenza , Influenza Humana , Estações do Ano , Humanos , Vacinas contra Influenza/imunologia , Vacinas contra Influenza/administração & dosagem , Influenza Humana/prevenção & controle , Influenza Humana/epidemiologia , República da Coreia/epidemiologia , Adulto , Feminino , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Idoso , Estudos de Casos e Controles , Vírus da Influenza A Subtipo H1N1/imunologia , Adulto Jovem , Eficácia de Vacinas , Vacinação
3.
J Korean Med Sci ; 39(3): e15, 2024 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-38258360

RESUMO

BACKGROUND: Bivalent booster mRNA vaccines containing the omicron-variant strains have been introduced worldwide in the autumn of 2022. Nevertheless, the omicron subvariants evoked another large coronavirus disease 2019 (COVID-19) pandemic wave in late 2022 and early 2023. METHODS: A retrospective, test-negative, case-control study was conducted to estimate the vaccine effectiveness (VE) of bivalent COVID-19 vaccines in 8 university hospitals between January and February 2023. The case and control groups were divided based on nasopharyngeal COVID-19 real-time polymerase chain reaction results and matched based on age, sex, hospital, and date (week) of the test performed. The VE of the BA.1- or BA.4/BA.5-based mRNA vaccines were estimated. VE was calculated using the 1-adjusted odds ratio from multivariable logistic regression. RESULTS: In total, 949 patients and 947 controls were enrolled in this study. VE for the BA.4/BA.5-based bivalent mRNA vaccine was 43% (95% confidence interval [CI], 17, 61%). In subgroup analysis based on age and underlying medical conditions, BA.4/BA.5-based bivalent mRNA vaccine was effective against old adults aged ≥ 65-years (VE, 55%; 95% CI, 23, 73%) and individuals with comorbidities (VE, 54%; 95% CI, 23, 73%). In comparison, the BA.1-based bivalent mRNA vaccine did not demonstrate statistically significant effectiveness (VE, 25%; 95% CI, -8, 49%). CONCLUSION: The BA.4/BA.5-based bivalent mRNA booster vaccine provided significant protection against COVID-19 in the Korean adults, especially in the older adults aged ≥ 65 years and in individuals with underlying medical conditions.


Assuntos
COVID-19 , Humanos , Idoso , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Estudos de Casos e Controles , Estudos Retrospectivos , Vacinas de mRNA , Hospitais Universitários , RNA Mensageiro/genética , República da Coreia/epidemiologia
4.
J Korean Med Sci ; 38(44): e371, 2023 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-37967881

RESUMO

Social isolation and control owing to coronavirus disease 2019 (COVID-19) are easing; however, concerns regarding new infectious diseases have not disappeared. Given epidemic experiences such as severe acute respiratory syndrome (SARS), the influenza pandemic, Middle East respiratory syndrome (MERS), and COVID-19, it is necessary to prepare for the outbreak of new infectious diseases and situations in which large-scale vaccinations are required. Although the development of vaccines against COVID-19 has contributed greatly to overcoming the pandemic, concerning vaccine side effects from the general public, including medical personnel, and decreased confidence in vaccine efficacy and side effects, present many challenges in promoting and educating vaccinations for new infectious diseases in the future. In addition to plans to develop vaccines for the outbreak of new infectious diseases, education and promotion plans are necessary to administer the latest developments of vaccines to the general public. Moreover, efforts are needed to secure the necessity, legitimacy, and evidence for rapid vaccination on a large scale at the national level. It is also necessary to carefully prepare scientific bases and explanatory statements so that the general public can easily understand them. This study aimed to establish vaccine strategies and vaccination education plans for new infectious diseases that may occur in the future. Many ways to promote vaccination to the general public and healthcare workers should be prepared to ensure that the latest vaccines against new infectious diseases are administered safely. Thus, education and promotion of vaccine efficacy and safety based on specific data from clinical studies are necessary.


Assuntos
COVID-19 , Doenças Transmissíveis Emergentes , Vacinas contra Influenza , Humanos , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Doenças Transmissíveis Emergentes/prevenção & controle , Vacinação
6.
J Microbiol Immunol Infect ; 55(4): 678-685, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35140038

RESUMO

PURPOSE: This study aimed to examine the changes in the characteristics of community-onset fluoroquinolone-resistant (FQ-R) Escherichia coli isolates causing community-acquired acute pyelonephritis (APN) in South Korea. METHODS: Blood or urine samples were prospectively collected from patients aged ≥15 years with community-acquired APN who were admitted to one of the eight Korean hospitals included in this study between September 2017 and August 2018. Phylogenetic typing, multilocus sequence typing, and molecular characterization of ß-lactamase resistance and plasmid-mediated quinolone resistance (PMQR) determinants were performed. The data were compared with those from a previous study with the same design conducted in 2010-2011. RESULTS: A total of 300 and 346 isolates were identified in 2010-2011 and 2017-2018, respectively. Among them, 76 (22.0%) and 77 (25.7%) FQ-R isolates were identified in 2010-2011 and 2017-2018, respectively. A significantly higher antimicrobial resistance against third-to fourth-generation cephalosporins, including cefotaxime (23.9% vs. 77.9%, P < 0.001), were observed among FQ-R isolates in 2017-2018 than among those in 2010-2011. A higher proportion of ST131 isolates (27.6% vs. 66.2%, P < 0.001), as well as isolates that had extended-spectrum ß-lactamase (ESBL)/plasmid-mediated AmpC ß-lactamase (PABL) (23.7% vs. 79.2%, P < 0.001), was observed in 2017-2018 than in 2010-2011. Further, more PMQR determinants (11.8% vs. 40.8%, P < 0.001) were observed in 2017-2018 than in 2010-2011. CONCLUSIONS: Among uropathogenic FQ-R E. coli isolates in South Korea, the prevalence of ST131 and the proportion of isolates containing ESBL and/or PMQR determinants have increased.


Assuntos
Infecções por Escherichia coli , Pielonefrite , Quinolonas , Escherichia coli Uropatogênica , Antibacterianos , Farmacorresistência Bacteriana , Fluoroquinolonas , Humanos , Tipagem de Sequências Multilocus , Filogenia , República da Coreia , beta-Lactamases
7.
BMC Infect Dis ; 22(1): 112, 2022 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-35105335

RESUMO

BACKGROUND: Inappropriate use of antibiotics not only increases antibiotic resistance as collateral damage but also increases clinical failure rates and medical costs. The purpose of this study was to determine the relationship between the appropriateness of antibiotic prescription and outcomes of community-acquired acute pyelonephritis (CA-APN). METHODS: A multicenter prospective cohort study was conducted at eight hospitals in Korea between September 2017 and August 2018. All hospitalized patients aged ≥ 19 years who were diagnosed with CA-APN on admission were recruited. The appropriateness of empirical and definitive antibiotics, as well as the appropriateness of antibiotic treatment duration and route of administration, was evaluated in accordance with the guideline and expert opinions. Clinical outcomes and medical costs were compared between patients who were administered antibiotics 'appropriately' and 'inappropriately.' RESULTS: A total of 397 and 318 patients were eligible for the analysis of the appropriateness of empirical and definitive antibiotics, respectively. Of them, 10 (2.5%) and 18 (5.7%) were administered 'inappropriately' empirical and definitive antibiotics, respectively. Of the 119 patients whose use of both empirical and definitive antibiotics was classified as 'optimal,' 57 (47.9%) received antibiotics over a longer duration than that recommended; 67 (56.3%) did not change to oral antibiotics on day 7 of hospitalization, even after stabilization of the clinical symptoms. Patients who were administered empirical antibiotics 'appropriately' had shorter hospitalization days (8 vs. 10 days, P = 0.001) and lower medical costs (2381.9 vs. 3235.9 USD, P = 0.002) than those who were administered them 'inappropriately.' Similar findings were observed for patients administered both empirical and definitive antibiotics 'appropriately' and those administered either empirical or definitive antibiotics 'inappropriately'. CONCLUSIONS: Appropriate use of antibiotics leads to better outcomes, including reduced hospitalization duration and medical costs.


Assuntos
Pielonefrite , Antibacterianos/uso terapêutico , Resistência Microbiana a Medicamentos , Hospitalização , Humanos , Estudos Prospectivos , Pielonefrite/tratamento farmacológico
8.
J Infect Chemother ; 27(7): 1013-1019, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33642250

RESUMO

BACKGROUND: Community-acquired acute pyelonephritis (CA-APN) is relatively rare in men. This study aimed to compare the clinical characteristics of CA-APN between male and female patients. METHODS: We prospectively collected the clinical and microbiological data of hospitalized CA-APN patients aged ≥19 years in South Korea from March 2010 to February 2011 in 11 hospitals and from September 2017 to August 2018 in 8 hospitals. Only the first episodes of APN of each patient during the study period were included. RESULTS: From 2010 to 2011, 573 patients from 11 hospitals were recruited, and from 2017 to 2018, 340 patients were recruited from 8 hospitals. Among them, 5.9% (54/913) were male. Male patients were older (66.0 ± 15.2 vs. 55.3 ± 19.0 years, P < 0.001), had a higher Charlson comorbidity index (1.3 ± 1.5 vs. 0.7 ± 1.2, P = 0.027), and had a higher proportion of structural problems in the urinary tract (40.7% vs. 6.1%, P < 0.001) than female patients. Moreover, the total duration of antibiotic treatment was longer (21.8 ± 17.8 d vs. 17.3 ± 9.4 d, P = 0.001) and the proportion of carbapenem usage was higher (24.1% vs. 9.5%, P = 0.001) in men than in women. Male patients were hospitalized for longer durations than female patients (median, 10 d vs. 7 d, P < 0.001). CONCLUSIONS: Male CA-APN patients were older and had more comorbidities than female CA-APN patients. In addition, male patients received antibiotic treatment for a longer duration than female patients.


Assuntos
Infecções Comunitárias Adquiridas , Pielonefrite , Doença Aguda , Infecções Comunitárias Adquiridas/tratamento farmacológico , Infecções Comunitárias Adquiridas/epidemiologia , Feminino , Humanos , Masculino , Pielonefrite/tratamento farmacológico , Pielonefrite/epidemiologia , República da Coreia/epidemiologia , Estudos Retrospectivos , Fatores de Risco
9.
Antibiotics (Basel) ; 10(1)2021 Jan 02.
Artigo em Inglês | MEDLINE | ID: mdl-33401660

RESUMO

The purpose of this study was to determine whether the fluoroquinolone (FQ) minimum inhibitory concentration (MIC) for the causative agent Escherichia coli influences the clinical response of FQ treatment at 72 h in patients with community-acquired acute pyelonephritis (CA-APN). We prospectively collected the clinical data of women with CA-APN from 11 university hospitals from March 2010 to February 2012 as well as E. coli isolates from the urine or blood. In total, 78 patients included in this study received FQ during the initial 72 h, and the causative E. coli was detected. The clinical response at 72 h was significantly higher in patients with a levofloxacin MIC ≤ 16 mg/L than in those with an MIC > 16 mg/L (70.4% vs. 28.6%, p = 0.038). No difference was observed in clinical response at 72 h based on ciprofloxacin MIC. To summarize, FQ can be an effective treatment option for CA-APN when levofloxacin MIC against E. coli is ≤16 mg/L.

10.
Influenza Other Respir Viruses ; 15(1): 99-109, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32844596

RESUMO

BACKGROUND: After pandemic, A(H1N1)pdm09 is generally known to be associated with younger adults' infection and greater severity than seasonal A(H3N2) but some inconsistences between recent studies exist. OBJECTIVES: We aimed to compare the epidemiology and clinical outcomes of A(H1N1)pdm09 and A(H3N2) to verify and consolidate about the knowledge of known differences of subtypes. METHODS: Data were retrospectively collected from the hospital-based influenza morbidity and mortality surveillance in South Korea in nine tertiary care hospitals, from August 31, 2014, to August 25, 2018. Patients with H1N1pdm09 or H3N2 infection admitted in the emergency room or ward were recruited. RESULTS: A total of 1747 patients had influenza A and were divided into two groups those with A(H1N1)pdm09 (n = 240) and those with A(H3N2) (n = 1507). A(H1N1)pdm09 group had younger age (mean age ± standard deviation 50.0 ± 18.8 in H1N1 vs 53.4 ± 21.1 in H3N2, P = .030), lower influenza vaccination (27.9% vs 43.9%, P < .001) and pneumococcal vaccination rates (41.0% vs 51.9%, P < .001), and fewer underlying diseases (67.5% vs 74.0%, P = .035) than the A(H3N2) group. Influenza A subtypes were not associated with pneumonia risk (adjusted odds ratios [AOR] of A(H1N1)pdm09: 0.7 [95% confidence interval [CI]: 0.4-1.2, P = .172]) and in-hospital mortality (hazard ratio (HR) of A(H1N1)pdm09: 1.0 (95% CI: 0.3-3.1, P = .983)). Influenza vaccination reduced in-hospital mortality in hospitalized patients (HR: 0.3 (95% CI: 0.1-0.7), P = .005). CONCLUSIONS: A(H1N1)pdm09 infection was more common in younger patients without significant difference in pneumonia risk and in-hospital mortality between subtypes. Influenza vaccination was associated with reduced in-hospital mortality.


Assuntos
Vírus da Influenza A Subtipo H1N1 , Vacinas contra Influenza , Influenza Humana , Adulto , Humanos , Vírus da Influenza A Subtipo H3N2 , Influenza Humana/epidemiologia , República da Coreia/epidemiologia , Estudos Retrospectivos , Estações do Ano
11.
Antibiotics (Basel) ; 9(9)2020 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-32961887

RESUMO

This study examined changes in the clinical characteristics of community-acquired acute pyelonephritis (CA-APN) in South Korea between the period 2010-2011 and 2017-2018. We recruited all CA-APN patients aged ≥19 years who visited eight hospitals in South Korea from September 2017 to August 2018, prospectively. Data collected were compared with those from the previous study in 2010-2012, with the same design and participation from 11 hospitals. A total of 617 patients were enrolled and compared to 818 patients' data collected in 2010-2011. Escherichia coli was the most common causative pathogen of CA-APN in both periods (87.3% vs. 86.5%, p = 0.680). E. coli isolates showed significantly higher antimicrobial resistance against fluoroquinolone (32.0% vs. 21.6%, p < 0.001), cefotaxime (33.6% vs. 8.3%, p < 0.001), and trimethoprim/sulfamethoxazole (37.5% vs. 29.2%, p = 0.013) in 2017-2018 than in 2010-2011. Total duration of antibiotic treatment increased from 16.55 ± 9.68 days in 2010-2011 to 19.12 ± 9.90 days in 2017-2018 (p < 0.001); the duration of carbapenem usage increased from 0.59 ± 2.87 days in 2010-2011 to 1.79 ± 4.89 days in 2010-2011 (p < 0.001). The median hospitalization was higher for patients in 2017-2018 than in 2010-2011 (9 vs. 7 days, p < 0.001). In conclusion, antimicrobial resistance of E. coli to almost all antibiotic classes, especially third generation cephalosporin, increased significantly in CA-APN in South Korea. Consequently, total duration of antibiotic treatment, including carbapenem usage, increased.

12.
Infect Chemother ; 52(2): 194-203, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32406212

RESUMO

BACKGROUND: Escherichia coli is the predominant causative pathogen for community-acquired urinary tract infections (UTIs), and the increase in fluoroquinolone-resistant E. coli is of great concern in Korea. The objectives of this study were to investigate the genotypic characteristics and molecular epidemiology of ciprofloxacin-resistant (CIP-R) E. coli isolated from community-acquired UTIs in Korea. MATERIALS AND METHODS: E. coli samples isolated from the blood or urine were collected from patients with community-acquired acute pyelonephritis aged 15 years and more who were admitted to 12 Korean hospitals from 1st April 2010 to 29th February 2012. Phylogenetic typing, multilocus sequence typing, and molecular characterization of ß-lactamase and plasmid-mediated quinolone resistance determinants were performed for CIP-R E. coli isolates. RESULTS: A total of 569 E. coli isolates were collected, and 122 (21.4%) isolates were CIP-R isolates. The most prevalent sequence type (ST) was ST131 (28.7%, 35/122), followed by ST393 (14.7%, 18/122), ST1193 (13.1%, 16/122), ST38 (9.0%, 11/122), and ST405 (8.2%, 10/122). The antimicrobial resistance rates of ST131 to cefepime (22.9%, 8/35), ST38 to gentamicin (100%, 11/11), and ST405 to cefotaxime (66.7%, 6/9) were significantly higher than the resistance rates of all other STs combined. Notably, 40% (4/10) of ST405 clones produced extended-spectrum ß-lactamases and were co-resistant to trimethoprim/sulfamethoxazole. aac(6')-1b-cr (20%, 7/35) and CTX-M-14 (40%, 4/10) were more frequently observed in ST131 and ST405 compared with other clones, respectively. CONCLUSIONS: Among the CIP-R uropathogenic E. coli isolates in this study, ST131, ST38, and ST405 were specifically associated with antimicrobial resistance.

13.
Vaccine ; 38(2): 318-322, 2020 01 10.
Artigo em Inglês | MEDLINE | ID: mdl-31690467

RESUMO

BACKGROUND: Annually, about 80% of the Korean elderly aged ≥65 years receive influenza vaccination. Repeated annual vaccination has been suggested as an important factor of poor influenza vaccine effectiveness (VE), though reported conflicting results. METHODS: During the consecutive A/H3N2-dominant influenza seasons between 2012 and 2015, we comparatively evaluated the VE (repeated vs. current season only) against laboratory-confirmed influenza, pneumonia and hospitalization in the elderly aged ≥65 years with influenza-like illness (ILI). Clinical and demographic data were collected prospectively, and vaccination status of prior and current seasons was verified using the immunization registry data of Korean Centers for Disease Control and Prevention. RESULTS: During the first A/H3N2-dominant season in 2012-2013, influenza vaccine showed statistically significant effectiveness against influenza A infection only and when vaccinated in the current season only (VE 53%, 95% CI 15-77). In the latter two seasons (2013-2015 years), the adjusted VE for influenza A was indistinguishable between repeated vaccination and vaccination in the current season only. CONCLUSION: During consecutive influenza A/H3N2 epidemics, poor influenza vaccine effectiveness may be more pronounced among the elderly population with a high annual vaccine uptake rate.


Assuntos
Vírus da Influenza A Subtipo H3N2/imunologia , Vacinas contra Influenza/administração & dosagem , Influenza Humana/prevenção & controle , Vacinação , Idoso , Idoso de 80 Anos ou mais , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Vírus da Influenza A Subtipo H3N2/isolamento & purificação , Vacinas contra Influenza/imunologia , Influenza Humana/imunologia , Influenza Humana/virologia , Masculino , Sistema de Registros , República da Coreia , Estações do Ano
14.
Infect Chemother ; 51(2): 161-170, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31270995

RESUMO

BACKGROUND: Scrub typhus, a mite-borne disease caused by bites of Orientia tsutsugamushi-infected chiggers, is endemic in Asia-Pacific countries. In Korea, it is a seasonal disease prevalent in autumn and one of the important causes of acute undifferentiated febrile illness. The purpose of this study was to identify the risk factors for the prediction of the severe clinical course of scrub typhus and to investigate the differences in the clinical and laboratory findings of hospitalized elderly and non-elderly patients with scrub typhus. MATERIALS AND METHODS: This study retrospectively reviewed the medical records of patients diagnosed with scrub typhus. RESULTS: A total of 710 patients were enrolled and 43.9% of them were elderly patients. The number of patients with complicated scrub typhus was 168 (23.7%) and the most common complication of severe scrub typhus was hepatic dysfunction (10.7%) followed by pneumonia (7.2%), acute kidney injury (4.9%) and shock (2.4%). Blood urea nitrogen ≥20 mg/dL, adenosine deaminase (ADA) ≥100 IU/L, pulmonary edema or pleural effusion, lactate dehydrogenase ≥500 U/L, alkaline phosphatase ≥400 IU/L, ferritin ≥500 ng/mL and absence of skin rash were independently associated with severe scrub typhus. There was no significant difference in the incidence of complicated scrub typhus between elderly and non-elderly patients. Absence of skin rash, pulmonary edema, pleural effusion, serum creatinine ≥1.5 mg/dL, total bilirubin ≥1.5 mg/dL, ADA ≥100 IU/L and ferritin ≥500 ng/mL were significantly associated with a longer hospitalization (≥10 days). CONCLUSION: The several independent predictors of complicated scrub typhus were identified in this study. Absence of skin rash, the increased levels of serum ADA and ferritin were identified as the predictors of complicated scrub typhus, which were also associated with a prolonged hospitalization.

15.
J Korean Med Sci ; 34(4): e31, 2019 Jan 28.
Artigo em Inglês | MEDLINE | ID: mdl-30686952

RESUMO

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.


Assuntos
Vacinas contra Difteria, Tétano e Coqueluche Acelular/imunologia , Tétano/prevenção & controle , Adolescente , Adulto , Anticorpos Antibacterianos/sangue , Vacinas contra Difteria, Tétano e Coqueluche Acelular/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mialgia/etiologia , Tétano/imunologia , Vacinação , Adulto Jovem
16.
Hum Vaccin Immunother ; 15(3): 710-716, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30396317

RESUMO

Two antigenically distinct influenza B lineage viruses (Yamagata/Victoria) have been co-circulating globally since the mid-1980s. The quadrivalent influenza vaccine (QIV) may provide better protection against unpredictable B strains. We conducted a randomized, double-blind, phase III trial to evaluate the immunogenicity and safety of an egg-based inactivated, split-virion QIV (GC3110A). Subjects aged ≥ 19 years were randomized 2:1:1 to be vaccinated with QIV- GC3110A, trivalent influenza vaccine (TIV) containing the Yamagata lineage strain (TIV-Yamagata), or TIV containing the Victoria lineage strain (TIV-Victoria). Hemagglutination inhibition assays were performed 21 days post-vaccination. Solicited/unsolicited adverse events (AEs) were assessed within 21 days after vaccination, while serious AEs were reported up to six months after vaccination. A total of 1,299 were randomized to receive QIV-GC3110A (648 subjects), TIV-Yamagata (325 subjects), or TIV-Victoria (326 subjects). Compared to the TIVs, the QIV-GC3110A met the non-inferiority criteria for all four subtype/lineage strains with respect to the geometric mean titer (GMT) ratio and the difference of seroconversion rate. The safety profiles of QIV-GC3110A were consistent with those of TIV. In conclusion, QIV-GC3110A is safe, immunogenic, and comparable to strain-matched TIV.


Assuntos
Anticorpos Antivirais/sangue , Imunogenicidade da Vacina , Vírus da Influenza A/imunologia , Vírus da Influenza B/imunologia , Vacinas contra Influenza/imunologia , Adulto , Antígenos Virais/química , Antígenos Virais/imunologia , Método Duplo-Cego , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Ovos , Feminino , Humanos , Vacinas contra Influenza/química , Influenza Humana/prevenção & controle , Masculino , Pessoa de Meia-Idade , Soroconversão , Vacinação , Vacinas de Produtos Inativados/química , Vacinas de Produtos Inativados/imunologia
17.
PLoS One ; 13(12): e0207918, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30521553

RESUMO

BACKGROUND: Influenza and pneumonia are leading causes of morbidity and mortality among the elderly. Although vaccination is a main strategy to prevent these infectious diseases, concerns remain with respect to vaccine effectiveness. METHODS: During three influenza seasons (2014-2015, 2015-2016 and 2016-2017), we evaluated the effectiveness of the influenza and pneumococcal vaccines against pneumonia and acute exacerbation of cardiopulmonary diseases among the elderly aged ≥65 years with influenza-like illness (ILI). Demographic and clinical data were collected prospectively. RESULTS: Among 2,119 enrolled cases, 1,302 (61.4%) and 871 (41.1%) received the influenza vaccine and 23-valent pneumococcal polysaccharide vaccine (PPV23), respectively. During an A/H3N2-dominant season with poor influenza vaccine effectiveness (2014-2015 season), neither the influenza vaccine nor PPV23 showed significant effectiveness against pneumonia or acute exacerbation of cardiopulmonary diseases. During seasons with good influenza vaccine effectiveness (2015-2016 and 2016-2017 seasons), the influenza vaccine was effective in preventing pneumonia, but PPV23 was not. In particular, the influenza vaccine was effective in preventing acute exacerbation of heart diseases (75.0%) during the A/H1N1-dominant 2015-2016 season. CONCLUSION: The influenza vaccine was effective in preventing pneumonia only during vaccine-matched seasons with good effectiveness against circulating influenza viruses. In addition, the influenza vaccine was cardio-protective during a vaccine-matched A/H1N1-dominant season.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Vacinas contra Influenza/farmacologia , Influenza Humana/prevenção & controle , Pneumopatias/prevenção & controle , Vacinas Pneumocócicas/farmacologia , Pneumonia Pneumocócica/prevenção & controle , Doença Aguda , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/epidemiologia , Estudos de Coortes , Feminino , Humanos , Vírus da Influenza A Subtipo H1N1 , Vírus da Influenza A Subtipo H3N2 , Influenza Humana/epidemiologia , Influenza Humana/virologia , Pneumopatias/epidemiologia , Masculino , Pneumonia Pneumocócica/epidemiologia , Estudos Prospectivos , República da Coreia/epidemiologia , Resultado do Tratamento
18.
Vaccine ; 36(35): 5304-5308, 2018 08 23.
Artigo em Inglês | MEDLINE | ID: mdl-30057284

RESUMO

We aimed to characterize the lineages of influenza B viruses obtained from clinical specimens during the 2007-2014 seasons in South Korea. RT-PCR for the partial hemagglutinin gene of influenza B virus was performed on laboratory-confirmed influenza B samples from the 2007-2008 season to 2013-2014 season. A phylogenetic tree was generated, and current influenza vaccine strains for the Northern Hemisphere were used as representative strains of Victoria and Yamagata lineages. A total of 571 influenza B virus sequences were analyzed. During the 2009-2010 season, most of the circulating influenza B viruses matched the vaccine strain; 91.0% (91/100) of viruses belonged to the Victoria lineage. In the 2007-2008, 2011-2012, and 2013-2014 seasons, co-circulation of each influenza B lineage was found with a match ratio to the vaccine strain of 53.2% (42/79), 40.9% (63/154), and 58.3% (134/230), respectively. Overall, 41.7% (238/571) of the circulating influenza B viruses belonged to the lineage mismatching the vaccine strain. During the seven influenza seasons, influenza B epidemics were substantial in four seasons in South Korea. Significant mismatches of the vaccine and lineage of the circulating influenza B viruses were found. The current trivalent influenza vaccine may not be fully suitable for effective protection against influenza B.


Assuntos
Vírus da Influenza B/imunologia , Vírus da Influenza B/patogenicidade , Vacinas contra Influenza/uso terapêutico , Humanos , Vacinas contra Influenza/imunologia , Influenza Humana/epidemiologia , Influenza Humana/prevenção & controle , Filogenia , República da Coreia
19.
Infect Chemother ; 50(1): 67-100, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29637759

RESUMO

Urinary tract infections (UTIs) are infectious diseases that commonly occur in communities. Although several international guidelines for the management of UTIs have been available, clinical characteristics, etiology and antimicrobial susceptibility patterns may differ from country to country. This work represents an update of the 2011 Korean guideline for UTIs. The current guideline was developed by the update and adaptation method. This clinical practice guideline provides recommendations for the diagnosis and management of UTIs, including asymptomatic bacteriuria, acute uncomplicated cystitis, acute uncomplicated pyelonephritis, complicated pyelonephritis related to urinary tract obstruction, and acute bacterial prostatitis. This guideline targets community-acquired UTIs occurring among adult patients. Healthcare-associated UTIs, catheter-associated UTIs, and infections in immunocompromised patients were not included in this guideline.

20.
Influenza Other Respir Viruses ; 12(4): 497-507, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29489060

RESUMO

BACKGROUND: The influenza virus is reportedly associated with 3-5 million cases of severe illness and 250 000-500 000 deaths annually worldwide. OBJECTIVES: We investigated the variation of influenza A virus in Korea and examined the association with death. METHODS: A total of 13 620 cases were enrolled in the Hospital-based Influenza Morbidity & Mortality surveillance system in Korea during 2011-2016. Among these cases, a total of 4725 were diagnosed with influenza using RT-PCR (influenza A; n = 3696, influenza B; n = 928, co-infection; n = 101). We used 254 viral sequences from the 3696 influenza A cases for phylogenetic analysis using the BioEdit and MEGA 6.06 programs. RESULTS: We found that the sequences of A/H3N2 in the 2011-2012 season belong to subgroup 3C.1, whereas the sequences in the 2012-2013 season pertain to subgroup 3C.2. The sequences in the 2013-2014 and 2014-2015 seasons involve subgroups 3C.3a and 3C.2a. The A/H1N1pdm09 subtype belongs to subgroup 6 and contains two clusters. In addition, sequence analysis confirmed the several substitutions of internal genes and gene substitutions associated with drug resistance (I222V in NA and S31N in M2) in the fatal cases. While statistical analysis found no significant associations between genetic differences in the viruses and mortality, mortality was associated with certain host factors, such as chronic lung disease. CONCLUSIONS: In conclusion, influenza A virus clade changes occurred in Korea during the 2011-2016 seasons. These data, along with antigenic analysis, can aid in selecting effective vaccine strains. We confirmed that fatality in influenza A cases was related to underlying patient diseases, such as chronic lung disease, and further studies are needed to confirm associations between mortality and viral genetic substitutions.


Assuntos
Vírus da Influenza A Subtipo H1N1/genética , Vírus da Influenza A Subtipo H3N2/genética , Influenza Humana/epidemiologia , Influenza Humana/virologia , Testes de Inibição da Hemaglutinação , Humanos , Filogenia , RNA Viral/genética , República da Coreia/epidemiologia , Estações do Ano , Fatores de Tempo
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