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Song J.Y.,Korea University | Song J.Y.,Transgovernmental Enterprise for Pandemic Influenza in Korea | Cheong H.J.,Korea University | Lee J.,Hallym University | And 11 more authors.
Vaccine | Year: 2015

Background: Cell culture-derived influenza vaccines (CCIVs) have several important advantages over egg-based influenza vaccines, including shorter production time, better preservation of wild-type virus antigenicity and large-scale production capacity. Methods: A randomized, double-blind, phase 3 trial was undertaken to evaluate the immunogenicity and safety of a novel cell culture-derived inactivated, subunit, trivalent influenza vaccine (NBP607, SK Chemicals, Seongnam, Korea) compared to the control vaccine (Agrippal®S1, Novartis Vaccines and Diagnostics Srl, Siena, Italy) among healthy adults aged 19 years or older (Clinical trial Number-NCT02344134). Immunogenicity was determined at pre-vaccination, 1 month and 6 month post-vaccination by the hemagglutination inhibition assay. Solicited and unsolicited adverse events were assessed after vaccination. Results: A total of 1156 healthy subjects were recruited. NBP607 met all of the criteria of Committee for Medicinal Products for Human Use (CHMP) at 21 days post-vaccination. Contrary to NBP607, the control vaccine did not satisfy the seroconversion criteria for influenza B irrespective of age. Although the geometric mean titer for each influenza subtype declined gradually, seroprotection rate still remained ≥80% for all subtypes up to six month after NBP607 administration. NBP607 recipients met the seroprotection criteria for all three influenza subtypes up to 6 month post-vaccination. There was no significant difference in the occurrence of adverse events between the NBP607 and control groups. Conclusion: NBP607, a novel CCIV, showed excellent immunogenicity that lasted ≥6 months after vaccination and had tolerable safety profiles. In particular, NBP607 was more immunogenic against influenza B compared to the control, an egg-based subunit vaccine. © 2015 Elsevier Ltd.


Noh J.Y.,Korea University | Kim W.J.,Korea University | Kim W.J.,Transgovernmental Enterprise for Pandemic Influenza in Korea
Infection and Chemotherapy | Year: 2013

Influenza is a worldwide public health concern. Since the introduction of trivalent influenza vaccine in 1978, vaccination has been the primary means of prevention and control of influenza. Current influenza vaccines have moderate efficacy, good safety, and acceptable tolerability; however, they have unsatisfactory efficacy in older adults, are dependent on egg supply for production, and are time-consuming to manufacture. This review outlines the unmet medical needs of current influenza vaccines. Recent developments in influenza vaccines are also described. © 2013 by The Korean Society of Infectious Diseases.


Seo Y.B.,Korea University | Choi W.S.,Korea University | Lee J.,Hallym University | Song J.Y.,Korea University | And 3 more authors.
Clinical and Vaccine Immunology | Year: 2014

The influenza vaccination is known as the most effective method for preventing influenza infection and its complications in the elderly. Conventional subunit (Agrippal S1; Novartis), MF59-adjuvanted (Fluad; Novartis), and intradermal (IDflu15; Sanofi Pasteur) influenza vaccines are widely used throughout South Korea. However, few comparative studies evaluating the safety and immunogenicity of these vaccines are available. Prior to the beginning of the 2011-2012 influenza season, 335 healthy elderly volunteers randomly received one of three seasonal trivalent influenza vaccines, the conventional subunit, MF59-adjuvanted, or intradermal influenza vaccine. Serum hemagglutination- inhibiting antibody levels were measured at the time of vaccination and at 1 and 6 months after vaccination. Adverse events were recorded prospectively. A total of 113 conventional subunit, 111 MF59-adjuvanted, and 111 intradermal influenza vaccine volunteers were followed up during a 6-month postvaccination period. One month after vaccination, all three vaccines satisfied Committee for Medical Products for Human Use (CHMP) immunogenicity criteria for the A/H1N1 and A/H3N2 strains but not for the B strain. Compared with the subunit vaccine, the intradermal vaccine exhibited noninferiority, while the MF59-adjuvanted vaccine exhibited superiority. Furthermore, the MF59-adjuvanted vaccine was more immunogenic against the A/H3N2 strain than was the subunit vaccine up to 6 months postvaccination. The most common local and systemic reactions to the conventional subunit, MF59-adjuvanted, and intradermal influenza vaccines were pain at the injection site (7.1%, 10.8%, and 6.3%, respectively) and generalized myalgia (0.9%, 8.1%, and 5.4%, respectively). Local and systemic reactions were similar among the three vaccine groups. MF59-adjuvanted vaccine exhibited superior immunogenicity compared with a conventional subunit vaccine and had a comparable safety profile. For older adults, the MF59-adjuvanted vaccine is preferable for providing superior immunogenicity. Copyright © 2014, American Society for Microbiology. All Rights Reserved.


Noh J.Y.,Korea University | Song J.Y.,Korea University | Cheong H.J.,Korea University | Choi W.S.,Korea University | And 11 more authors.
PLoS ONE | Year: 2013

Background:A well-constructed and properly operating influenza surveillance scheme is essential for public health. This study was conducted to evaluate the distribution of respiratory viruses in patients with influenza-like illness (ILI) through the first teaching hospital-based surveillance scheme for ILI in South Korea.Methods:Respiratory specimens were obtained from adult patients (≥18 years) who visited the emergency department (ED) with ILI from week 40, 2011 to week 22, 2012. Multiplex PCR was performed to detect respiratory viruses: influenza virus, adenovirus, coronavirus, respiratory syncytial virus, rhinovirus, human metapneumovirus, parainfluenza virus, bocavirus, and enterovirus.Results:Among 1,983 patients who visited the ED with ILI, 811 (40.9%) were male. The median age of patients was 43 years. Influenza vaccination rate was 21.7% (430/1,983) during the 2011-2012 season. At least one comorbidity was found in 18% of patients. The positive rate of respiratory viruses was 52.1% (1,033/1,983) and the total number of detected viruses was 1,100. Influenza A virus was the dominant agent (677, 61.5%) in all age groups. The prevalence of human metapneumovirus was higher in patients more than 50 years old, while adenovirus was detected only in younger adults. In 58 (5.6%) cases, two or more respiratory viruses were detected. The co-incidence case was identified more frequently in patients with hematologic malignancy or organ transplantation recipients, however it was not related to clinical outcomes.Conclusion:This study is valuable as the first extensive laboratory surveillance of the epidemiology of respiratory viruses in ILI patients through a teaching hospital-based influenza surveillance system in South Korea. © 2013 Noh et al.


Choi W.S.,Korea University | Noh J.Y.,Korea University | Baek J.H.,Inha University | Seo Y.B.,Hallym University | And 7 more authors.
PLoS ONE | Year: 2015

Background: The effectiveness of the 2011-2012 seasonal influenza vaccine was evaluated in adult Korean populations with regard to how well it could prevent laboratory-confirmed influenza and influenza-related complications. Materials and Methods: A retrospective case-control and retrospective cohort study was conducted among patients who visited four selected hospitals from September 2011 to May 2012. The analysis included 1,130 laboratory-confirmed influenza patients. For each influenza case, one control patient was chosen at a ratio of 1:1. A control was defined as an age group-matched patient who visited the same hospital with influenza-like illness within 48 hours of symptom onset but for whom laboratory tests were negative for influenza. Age group and visit date were matched between the cases and controls. Vaccine effectiveness (VE) was defined as [100 × (1-odds ratio for influenza in vaccinated versus non-vaccinated persons)]. The patients with laboratory-confirmed influenza were followed for at least one month through reviewing the medical records and conducting a telephone interview. Results: The VE of the 2011-2012 seasonal influenza vaccine was 3.8% [95% confidence interval (CI), -16.5% to 20.6%] for preventing laboratory-confirmed influenza, -16.1% (95% CI, -48.3 to 9.1) for influenza A and 26.2%(95% CI, -2.6 to 46.2) for influenza B. The age-specific adjusted VE was 0.3% (95% CI, -29.4 to 23.1) among participants aged 19 to 49 years, 11.9% (95% CI, -34.3 to 42.2) among those aged 50 to 64 years and -3.9% (-60.1 to 32.5) among those aged ≥65 years. The adjusted VE for preventing any influenza-related complications was -10.7% (95% CI, -41.1% to 42.2%). Conclusions: The 2011-2012 seasonal influenza vaccine was not effective in preventing laboratory-confirmed influenza or influenza-related complications in adult Korean populations. © 2015 Choi et al.


Seo Y.B.,Korea University | Hong K.-W.,Korea University | Kim I.S.,Korea University | Choi W.S.,Korea University | And 7 more authors.
Vaccine | Year: 2013

Background: Influenza epidemics are accompanied by a considerable increase in hospitalization due to acute lower respiratory infection and exacerbation of underlying medical conditions. We estimated the effectiveness of the influenza vaccine at preventing hospitalization due to acute lower respiratory infection and new onset or acute exacerbation of chronic cardiopulmonary disease. Method: During the peak influenza period in 2010-2011, we performed a multicenter, case-control, retrospective cohort study of patients who were hospitalized due to newly developed pneumonia, bronchitis, and bronchiolitis, or new onset or acute exacerbation of asthma, COPD, ischemic heart disease, and CHF. Controls were selected from outpatients who visited study hospitals but who were not hospitalized during the same study period. Controls were matched 1:1 to cases based on age, gender, and date of hospital visit. Univariate and multivariate logistic regression analyses were used to determine the effectiveness of the influenza vaccine at decreasing hospitalization. Results: Between December 2010 and February 2011, 556 hospitalized subjects were identified. Age, gender, and body mass index (BMI) were similar between case and control groups. The influenza vaccination rate of the hospitalized and non-hospitalized patients was 42.4% and 52.2%, respectively (p<. 0.001). The overall vaccine effectiveness for preventing hospitalization was 32.5% (odds ratio 0.675, 95% confidence interval [CI] 0.486-0.937; p=. 0.019). Multivariate logistic analysis showed that influenza vaccination significantly reduced the risk of hospitalization, especially due to new onset or acute exacerbation of ischemic heart disease and CHF in patients aged 65 years and older (OR 0.274, 95% CI 0.114-0.658, p=. 0.004). The estimated vaccine effectiveness in these patients was 72.6%. Conclusion: Influenza vaccination reduced the rate of hospitalization among patients with underlying chronic heart disease, particularly those patients 65 years old and greater. © 2012 Elsevier Ltd.


Noh J.Y.,Korea University | Choi W.S.,Korea University | Lee J.,Hallym University | Kim H.L.,Transgovernmental Enterprise for Pandemic Influenza in Korea | And 4 more authors.
Diagnostic Microbiology and Infectious Disease | Year: 2015

The Sofia™ Influenza A. +. B FIA demonstrated 74.0% sensitivity and 95.4% specificity for influenza A in patients with influenza-like illness in 2012-2013 season. It yielded higher sensitivity than SD Bioline Influenza Ag A/B/A(H1N1/2009) (54.1%) for influenza A (. P<. 0.01). The Sofia™ Influenza A. +. B FIA might be useful for rapid diagnosis of influenza. © 2015 Elsevier Inc..


Choi W.S.,Korea University | Noh J.Y.,Korea University | Seo Y.B.,Korea University | Baek J.H.,Inha University | And 7 more authors.
Clinical and Vaccine Immunology | Year: 2013

We evaluated the effectiveness of the 2010-2011 seasonal influenza vaccine for preventing laboratory-confirmed influenza in a South Korean population. A retrospective case-control study was conducted among patients who visited selected hospitals from September 2010 to May 2011. A total of 483 laboratory-confirmed influenza patients were included in the analysis as case subjects. For each case patient, two types of control patients were chosen at a ratio of 1:1:1, and 966 control subjects were selected. Vaccine effectiveness (VE) was defined as 100 x (1 - odds ratio for influenza in vaccinated versus nonvaccinated persons). The VE of the 2010-2011 seasonal influenza vaccine was 49.5% to 45.8% for both influenza A and B viruses and 50.8% to 47.2% for influenza A virus, according to the control type. The age-specific adjusted VE was 50.8% to 46.5% among subjects aged 19 to 49 years and 58.7% to 63.3% among those aged 50 to 64 years, according to the control type. Statistically significant VE was not found among those aged ≥65 years or against influenza B virus. The 2010-2011 seasonal influenza vaccine was effective for preventing laboratory-confirmed influenza, especially for influenza A virus, in a South Korean population. Evidence of the effectiveness of the influenza vaccine in older adults or against influenza B virus was not found. Copyright © 2013, American Society for Microbiology. All Rights Reserved.


Jeong H.W.,Chungbuk National University | Heo J.Y.,Chungbuk National University | Park J.S.,Chungbuk National University | Kim W.J.,Korea University | Kim W.J.,Transgovernmental Enterprise for Pandemic Influenza in Korea
PLoS ONE | Year: 2014

Methods: Data from patients suffering from an influenza-like illness (ILI) and who were discharged after visiting the ED at Chungbuk National University Hospital were reviewed over two influenza seasons: 2010-2011, when IVRAT was not used in the ED, and 2011-2012, when it was. The numbers of antibiotic prescriptions issued and the ED LOS during these two seasons were then compared.Results: The number of antibiotic prescriptions was significantly lower in 2011-2012 (54/216, 25.0%) than in 2010-2011 (97/221, 43.9%; P<0.01). However, the median ED LOS for patients in 2011-2012 was much longer than that of patients in 2010-2011 (213 minutes vs. 257 minutes; P<0.01). During the 2011-2012 influenza season, 73 ILI patients showed a positive IVRAT result whereas 123 showed a negative result. Upon discharge, antibiotics were given to 42/123 (34.1%) ILI patients with a negative IVRAT result, but to only 7/73 (9.6%) patients with a positive IVRAT result (P<0.01).Conclusions: Performing IVRAT in the ED reduced the prescription of antibiotics to ILI patients discharged after ED care. However, the ED LOS for patients who underwent IVRAT was longer than that for patients who did not. Thus, performing IVRAT in the ED reduces the unnecessary prescription of antibiotics to ILI patients during the influenza season.Background: Influenza virus infection is a common reason for visits to the emergency department (ED) during the influenza season. A rapid and accurate diagnosis of influenza virus infection is important to reduce unnecessary antibiotic prescription and to improve patient care. The aim of this study was to examine whether using the Influenza Virus Rapid Antigen Test (IVRAT) in the ED affects the decision to prescribe antibiotics or the length of hospital stay (LOS). © 2014 Jeong et al.


Seo Y.B.,Korea University | Choi W.S.,Korea University | Baek J.H.,Inha University | Lee J.,Hallym University | And 5 more authors.
Human Vaccines and Immunotherapeutics | Year: 2014

There is a lack of targeted studies to validate the effectiveness of influenza vaccination on the reduction in influenzarelated hospitalizations among patients with co-morbidities. In this study, we estimate the effectiveness of influenza vaccination on preventing hospitalizations in persons with cardiopulmonary disease and establish an evidence base for recommendations on influenza vaccination in this population. During the influenza epidemic in 2011-2012, we performed a multicenter, retrospective case-control study. Cases were patients hospitalized due to acute exacerbation of asthma, COPD, ischemic heart disease (IHD), and congestive heart failure (CH F). Controls were selected from outpatients who visited study hospitals but who were not hospitalized. Cases and controls were matched 1:1 based on age, gender, and date of hospital visit. Conditional logistic regression analyses were used to determine the effectiveness of vaccination. Between 25 December 2011 and 5 May 2012, 828 of each hospitalized and control subjects were identified. The influenza vaccination rate of the hospitalized and non-hospitalized patients was 54.2% and 60.4%, respectively (P = 0.006). The overall vaccine effectiveness for preventing hospitalization was 33.7% (95% confidence interval [CI] 14.0-49.0%; P =0.002). Conditional logistic regression analysis showed that influenza vaccination significantly reduced the risk of hospitalization, especially due to acute exacerbation of IHD and CH F, in patients aged 65 y and older. The estimated vaccine effectiveness in these patients was 56.0% (95% CI 32.1-71.4%, P = 0.002). Influenza vaccination was associated with a reduction in the risk of hospitalization due to acute exacerbation of cardiopulmonary disease. We recommend the vaccine be given primarily to patients with underlying cardiovascular disease, particularly those 65 y of age and older. © 2014 Landes Bioscience.

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