1.A 6-year Prospective, Observational, Multi-Center Post-Marketing Surveillance of the Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine in Korea
Hee Jin PARK ; Sung Jin KIM ; Rok SONG ; Jing CHEN ; Joon Hyung KIM ; Raghavendra DEVADIGA ; Hee Cheol KANG
Journal of Korean Medical Science 2019;34(12):e105-
BACKGROUND: Incidence of whooping cough is increasing in Korea. Since 2011, occurrence among adolescents and adults has risen putting vulnerable neonates at risk. National immunization guidelines now include Tdap (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis) vaccination during pregnancy and as a cocooning strategy (i.e., vaccinating adults and adolescents in contact with neonates). This study assessed post-marketing Tdap (Boostrix®, GSK, Belgium) vaccine safety in subjects ≥ 10 years. METHODS: This open, non-comparative multi-center study was conducted over six years at 10 hospitals in Korea. Subjects received Tdap in normal clinical practice according to local prescribing information. All adverse events (AEs) were recorded, classified as expected or unexpected, and severity and relationship to Tdap were assessed. RESULTS: The analysis included 672 Korean subjects (mean age, 44 years; range, 11–81), 451 were women and 211 were pregnant. Ninety subjects experienced 124 AEs (incidence 13.39%) of which six were serious AEs (SAEs) assessed as not related to vaccination, and 51 were non-SAEs related to vaccination (mostly administration site reactions). Overall 65/124 AEs were unexpected; the most common were 14 constipation, 5 dyspepsia, 4 common cold and 4 premature labor cases. One case of common cold was assessed as possibly related to vaccination. Pregnancy outcome was ‘live infant, no apparent congenital anomaly’ in 195 subjects (92.42%) or ‘lost to follow-up’ in 16 subjects. CONCLUSION: Tdap administration to Korean subjects ≥ 10 years, including pregnant women, for the prevention of diphtheria, tetanus and pertussis was shown to have a well-tolerated safety profile. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01929291
Adolescent
;
Adult
;
Common Cold
;
Constipation
;
Diphtheria Toxoid
;
Diphtheria
;
Dyspepsia
;
Female
;
Humans
;
Immunization
;
Incidence
;
Infant
;
Infant, Newborn
;
Korea
;
Obstetric Labor, Premature
;
Pregnancy
;
Pregnancy Outcome
;
Pregnant Women
;
Prospective Studies
;
Tetanus Toxoid
;
Tetanus
;
Vaccination
;
Whooping Cough
2.Evaluation of Potency on Diphtheria and Tetanus Toxoid for Adult Vaccines by In Vivo Toxin Neutralization Assay Using National Reference Standards.
Chan Woong CHOI ; Jae Hoon MOON ; Jae Ok KIM ; Si Hyung YOO ; Hyeon Guk KIM ; Jung Hwan KIM ; Tae Jun PARK ; Sung Soon KIM
Osong Public Health and Research Perspectives 2018;9(5):278-282
OBJECTIVES: Vaccinations against diphtheria and tetanus are essential in providing immunity against these bacterial infections. The potency of diphtheria and tetanus toxoid vaccines can be measured using the in vivo toxin neutralization assay. The limit of potency of this assay was determined only for children. Therefore, we assessed the potency of adult vaccines using this assay to identify the feasibility of limit for adult vaccines. METHODS: Fifteen lots of tetanus-reduced diphtheria and tetanus-diphtheria-acellular pertussis vaccines were used. In vivo toxin neutralization and lethal challenge assays were conducted on each vaccine to calculate the potencies of the toxoids. National reference standards for toxins and antitoxins were used for in vivo toxin neutralization assay. RESULTS: All 15 lots satisfied the limits of potency for lethal challenge assay. The potency of diphtheria and tetanus toxoids exceeded 1 and 8 units/mL, respectively, for in vivo toxin neutralization assay. CONCLUSION: Although additional studies are required for new assays and limits, the current level of potency for adult vaccines as determined by in vivo toxin neutralization assay, was demonstrated in this study. Such efforts to improve assays are expected to promote the development of diphtheria and tetanus vaccines for adults and to contribute to vaccine self-sufficiency.
Adult*
;
Antitoxins
;
Bacterial Infections
;
Child
;
Diphtheria Toxoid
;
Diphtheria*
;
Humans
;
Tetanus Toxoid*
;
Tetanus*
;
Toxoids
;
Vaccination
;
Vaccines*
;
Whooping Cough
3.Knowledge, Attitude and Practice on Maternal Immunization with Tetanus Toxoid, Reduced Diphtheria Toxoid, and Aellular Pertussis (Tdap) among Pregnant Women
Shin Hye LEE ; Bo Kyeung JIN ; Kyeung Suk BAEK ; Yong Sun CHO ; Taek Jin LEE
Pediatric Infection & Vaccine 2018;25(3):141-147
PURPOSE: Despite effectiveness and safety of maternal tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccination, Tdap vaccination coverage during pregnancy remains quite low. We assessed the knowledge, attitude and practice on maternal Tdap vaccination among pregnant women. METHODS: This study was a cross-sectional survey of pregnant women who visited tertiary obstetrics and gynecologic units in Seoul and Gyeonggi province of Korea. Individual questionnaires were administered to assess knowledge, attitude and practice on maternal immunization with Tdap. RESULTS: The questionnaires were completed by 184 pregnant women; 158 (86%) had not received information from doctors about pertussis and Tdap, and 166 (90%) did not know the need for Tdap vaccination. Only 7% of pregnant women unlikely to receive Tdap vaccine during current pregnancy answered 3 or more of the 5 knowledge-based questions correctly. By logistic regression analysis, recommendation by doctor (adjusted odd ratio [OR], 236.2; 95% confidence interval [CI], 12.6–4,432), belief that the vaccine is effective (adjusted OR, 40.21; 95% CI, 2.35–687.7), and belief that the vaccine is safe (adjusted OR, 19.83; 95% CI, 1.54–255.9) were significantly important factors to respondents’ intention to be vaccinated. CONCLUSIONS: Most pregnant women seem to be neither recommended nor adequately informed about Tdap vaccination. Information given by health care professionals is very important to increase Tdap coverage among pregnant women.
Cross-Sectional Studies
;
Delivery of Health Care
;
Diphtheria Toxoid
;
Diphtheria
;
Female
;
Gyeonggi-do
;
Humans
;
Immunization
;
Intention
;
Korea
;
Logistic Models
;
Obstetrics
;
Pregnancy
;
Pregnant Women
;
Seoul
;
Tetanus Toxoid
;
Tetanus
;
Vaccination
;
Whooping Cough
4.A Bordetella pertussis proteoliposome induces protection in mice without affecting the immunogenicity of diphtheria and tetanus toxoids in a trivalent formulation.
Sonsire Fernández CASTILLO ; Mario Landys CHOVEL ; Niurka Gutiérrez HERNÁNDEZ ; Lorena Corcho GONZÁLEZ ; Amaya BLANCO ; Daily Serrano HERNÁNDEZ ; Mildrey Fariñas MEDINA ; Maydelis Alvarez TITO ; José Luis Pérez QUIÑOY
Clinical and Experimental Vaccine Research 2016;5(2):175-178
In this study, a formulation of Bordetella pertussis proteoliposome (PLBp), diphtheria, and tetanus toxoids and alum (DT-PLBp) was evaluated as a trivalent vaccine candidate in BALB/c mice. Vaccine-induced protection was estimated using the intranasal challenge for pertussis and enzyme-linked immunosorbent assay fvto assess serological responses for diphtheria or tetanus. Both, diphtheria-tetanus-whole cell pertussis (DTP) and diphtheria-tetanus vaccines (DT) were used as controls. Animals immunized with DT-PLBp, PLBp alone, and DTP showed total reduction of CFU in lungs 7 days after intranasal challenge. Likewise, formulations DT-PLBp, DTP, and DT elicited antibody levels ≥2 IU/mL against tetanus and diphtheria, considered protective when neutralization tests are used. Overall, results showed that combination of PLBp with tetanus and diphtheria toxoids did not affect the immunogenicity of each antigen alone.
Animals
;
Bordetella pertussis*
;
Bordetella*
;
Diphtheria Toxoid
;
Diphtheria*
;
Enzyme-Linked Immunosorbent Assay
;
Lung
;
Mice*
;
Neutralization Tests
;
Tetanus Toxoid*
;
Tetanus*
;
Vaccines
;
Whooping Cough
5.Active Surveillance of Pertussis in Infants Under 6 Months of Age: A Single Center Experience from 2011 to 2013.
Young Ik HAN ; Ji Yeon CHOI ; Hyewon LEE ; Teak Jin LEE
Korean Journal of Pediatric Infectious Diseases 2014;21(2):114-120
PURPOSE: The objective of this study was to assess and investigate the epidemiology of pertussis in infants under 6 months of age. METHODS: A prospective study was conducted between October 1, 2011 and April 30, 2013 in CHA Bundang Medical Center, Seongnam, South Korea. Polymerase chain reaction (PCR) or culture was used to detect Bordetella pertussis in nasopharyngeal aspirates from case patients who were hospitalized for acute lower respiratory tract infection (LRTI). In addition, multiplex real-time PCR assays were also performed to detect 6 etiologic viruses, including adenovirus, human metapeumovirus, influenza virus, parainfluenza virus, respiratory syncytial virus and rhinovirus. RESULTS: Of the 79 enrolled case patients, whose median age was 2 months of age, the most common diagnoses uncovered in this study were acute bronchiolitis (60%) and pneumonia (28%). B. pertussis infection was found in 13 cases (16%), in which 7 (53%) was coinfected with respiratory syncytial virus and 1 (7%) with influenza A virus. Of the 13 patients with B. pertussis infection, 6 (46%) were not vaccinated with the diphtheria, tetanus toxoid, and acellular pertussis vaccine, while 6 (46%) received 1 dose, and 1 (8%) received 2 doses. CONCLUSION: B. pertussis infection was present in 16% of under 6 month-old infants, who were hospitalized for acute LRTI. Therefore, a nationwide epidemiological surveillance of pertussis, including institutions that cater to infants under 6 months of age is necessary and needed.
Adenoviruses, Human
;
Bordetella pertussis
;
Bronchiolitis
;
Diagnosis
;
Diphtheria
;
Epidemiology
;
Gyeonggi-do
;
Humans
;
Infant*
;
Influenza A virus
;
Korea
;
Orthomyxoviridae
;
Paramyxoviridae Infections
;
Pertussis Vaccine
;
Pneumonia
;
Polymerase Chain Reaction
;
Prospective Studies
;
Real-Time Polymerase Chain Reaction
;
Respiratory Syncytial Viruses
;
Respiratory Tract Infections
;
Rhinovirus
;
Tetanus Toxoid
;
Vaccination
;
Whooping Cough*
6.A Study on the Discourse and Reality of Abortion in Korea: 1920s~1930s.
Korean Journal of Medical History 2013;22(1):133-178
This paper tried to collect, classify and analyse the discourse about abortion in 1920~1930. In Korea, modern medical abortion operation started in 1920~30s. At that time abortion was prohibited by the Japanese Government-General of Korea, because the Japanese Government-General of Korea needed large population which was used for labor and exploitation. Hence, the Empire of Japan de-penalized Japanese criminal law related to birth control but Korean law was not revised between 1910~1945. Nevertheless, there were quite a few women who wanted abortion when they had children born in sin or they were too poor to raise their children, so they had abortion secretly. At that time the women generally had abortion through toxic drugs or foods and violence (dropping from a high place or beating their stomach). But high class women did it by medical operation. In 1920s, there was few Korean (modern) medical doctors who could operate for abortion, instead Japanese immigrant medical doctors did it--as the newspaper of that time showed(there were many pieces of news that Japanese doctor who helped abortion was arrested by the police). As time went by Korean doctors got their say about the technique and various knowledge of abortion in newspapers, magazines, and academic Journals; this was especially the case starting in 1930. It is worth noting that they were sometimes arrested for illegal abortion operations. Furthermore, from the late 1920s the insist that abortion should be permitted for women and poor people, appeared. This insist was affected by Japan, the Soviet Union and other countries which was generous with abortion.
Abortion, Criminal
;
Asian Continental Ancestry Group
;
Child
;
Contraception
;
Criminal Law
;
Diphtheria Toxoid
;
Emigrants and Immigrants
;
Female
;
Haemophilus Vaccines
;
Humans
;
Hypogonadism
;
Japan
;
Jurisprudence
;
Korea
;
Mitochondrial Diseases
;
Newspapers
;
Ophthalmoplegia
;
Periodicals as Topic
;
USSR
;
Vaccines, Conjugate
;
Violence
7.The contraindication of comedication drugs and drug utilization review.
Journal of the Korean Medical Association 2012;55(5):484-490
A drug interaction can be defined as an interaction between a drug and other drugs that prevent the drug from performing as expected. These processes may include alterations in the pharmacokinetics of the drug, such as modulations in the absorption, distribution, metabolism, and elimination (ADME) of a drug. Alternatively, drug interactions may be the result of the pharmacodynamic characteristics of the drug: the concomitant medication of a receptor antagonist and an agonist for the same receptor. The following interaction may increase or decrease the effectiveness of the drugs or the adverse drug reactions of the drugs. The possibilities of drug interactions should increase as the number of drugs being taken increases in patients. Therefore, patients taking several drugs simultaneously are at the greatest risk for interactions. Drug interactions can contribute to the increasing cost of healthcare because of the costs of medical care that are required to treat problems caused by changes in effectiveness or adverse drug reactions. The drug utilization review (DUR) system has been defined as a structured, ongoing initiative that interprets patterns of drug usage in relation to predetermined criteria and attempts to prevent or minimize inappropriate prescribing. The primary objectives of DUR are to improve the quality of health care for healthcare members and to assist in containing health care costs. In order to achieve these goals, prescription claims must be reviewed both prospectively and retrospectively. The DUR system supplies information to prohibit co-dispensing of contraindicated drugs which increases the risk of drug interactions properly to all the healthcare professionals participating in the care of the patients. In this article, we suggest the importance of DUR in relation to the contraindication of co-medication drugs.
Absorption
;
Delivery of Health Care
;
Diphtheria Toxoid
;
Drug Interactions
;
Drug Toxicity
;
Drug Utilization
;
Drug Utilization Review
;
Equipment and Supplies
;
Haemophilus Vaccines
;
Health Care Costs
;
Humans
;
Inappropriate Prescribing
;
Prescriptions
;
Quality of Health Care
8.The Influence of Postoperative Lesion-Down Head Position on the Recurrence Rate in Chronic Subdural Hematoma after Burr-Hole Surgery.
Gyu Seong BAE ; Seung Won CHOI ; Hyon Jo KWON ; Seon Hwan KIM ; Hyeon Song KOH ; Jin Young YOUM ; Shi Hun SONG
Korean Journal of Neurotrauma 2012;8(2):134-138
OBJECTIVE: Chronic subdural hematoma is a common disorder observed in neurosurgical care and the recurrence rate is relatively high. In this report, we evaluated the relationship between the recurrence rate of chronic subdural hematoma and the postoperative head position of the patient. METHODS: We conducted a retrospective study of 72 patients with unilateral chronic subdural hematoma treated by burr hole surgery with closed system drainage from October 2009 to May 2011. In group A, there was no restriction in head position for days keeping the catheter. In group B, the patients were placed with the lesion side of the head downward after the operation. We analyzed the recurrence rate, amount of postoperative drainage and changes in computed tomography finding of group A and B. RESULTS: Group A and group B consisted of 36 cases, respectively. The mean amount of total postoperative drainage was 248.8+/-127.2 mL in group A and 176.3+/-98.9 mL in group B (p=0.01). The improvement rates of midline shifting before and after surgery showed 60.5+/-25.6% in group A and 73.4+/-26.3% in group B (p=0.039). The total recurrence rate in group A was 11.1% and 5.6% in group B. CONCLUSION: By facing the lesion downward after surgical treatment, chronic subdural hematoma is thought to help reexpand the brain and to prohibit cerebrospinal fluid from flowing into subdural space and to decrease the recurrence rate better than having a free position.
Brain
;
Catheters
;
Diphtheria Toxoid
;
Drainage
;
Haemophilus Vaccines
;
Head
;
Hematoma, Subdural
;
Hematoma, Subdural, Chronic
;
Humans
;
Recurrence
;
Retrospective Studies
;
Subdural Space
9.Effect of Hyperkalemia and Hemolysis Caused by Hyperacute Rejection on Cardiac Function in Pig to Human Ex Vivo Xenogeneic Cardiac Perfusion Model.
Jun Seok KIM ; Hak Mo LEE ; Byoung Chol OH ; Hong Gook LIM ; Jeong Ryul LEE
Korean Circulation Journal 2011;41(3):130-136
BACKGROUND AND OBJECTIVES: Hyperacute rejection (HAR) is a major obstacle to successful xenotransplantation of vascularized organs. This study was conducted to observe the effect of hemolysis of perfused human whole blood on pig heart function, and determine the major risk factors for preservation of xenoperfused cardiac function using ex-vivo pig to human xenogeneic cardiac perfusion model. MATERIALS AND METHODS: Harvested pig hearts were perfused with normal human whole blood (group 1), two different types of pre-treated human whole blood (group 2: immunoglobulins were depleted by plasmapheresis, group 3: pre-treated with plasmapheresis, GAS914, cobra venom factor (CVF) and steroid), and normal porcine whole blood as control (group 4) for 3 hours. RESULTS: Duration of heart beat was significantly prolonged in group 2 and group 3. Histological examination showed widespread HAR features but was gradually delayed in groups 2 and 3 compared to group 1. The absolute levels of serum creatine kinase-MB and Troponin I increased gradually, and was lower in group 3. Serum hemoglobin levels were rapidly increased in groups 3 and 4, compared to group 1. Extracellular potassium level increased sharply from the beginning of blood perfusion in groups 1, 2 and 3, compared to group 4. CONCLUSION: Pretreatment of human whole blood, including immunoglobulin depletion, CVF and steroid reduced and delayed the destruction of pig myocardium by HAR. However, the increased extracellular potassium levels in groups 1, 2 and 3 reflected that these treatments could not prohibit myocardial injury by HAR.
Cobra Venoms
;
Creatine
;
Diphtheria Toxoid
;
Extracorporeal Circulation
;
Haemophilus Vaccines
;
Heart
;
Hemoglobins
;
Hemolysis
;
Humans
;
Hyperkalemia
;
Immunoglobulins
;
Myocardium
;
Perfusion
;
Plasmapheresis
;
Potassium
;
Rejection (Psychology)
;
Risk Factors
;
Transplantation, Heterologous
;
Trisaccharides
;
Troponin I
10.Postoperative Systemic Dissemination of Injected Elemental Mercury.
Suk Hyung KANG ; Seung Won PARK ; Kyung Yoon MOON
Journal of Korean Neurosurgical Society 2011;49(4):245-247
There were only a few reports of mercury on pulmonary artery. However, there is no data on surgery related mercury dissemination. The objective of the present article is to describe one case of postoperative injected mercury dissemination. A 19-year-old man presented severe neck pain including meningeal irritation sign and abdominal pain after injection of mercury for the purpose of suicide. Radiologic study showed injected mercury in the neck involving high cervical epidural space and subcutaneous layer of abdomen. Partial hemilaminectomy and open mercury evacuation of spinal canal was performed. For the removal of abdominal subcutaneous mercury, C-arm guided needle aspiration was done. After surgery, radiologic study showed disseminated mercury in the lung, heart, skull base and low spinal canal. Neck pain and abdominal pain were improved after surgery. During 1 month after surgery, there was no symptom of mercury intoxication except increased mercury concentration of urine, blood and hair. We assumed the bone work during surgery might have caused mercury dissemination. Therefore, we recommend minimal invasive surgical technique for removal of injected mercury. If open exposures are needed, cautious surgical technique to prohibit mercury dissemination is necessary and normal barrier should be protected to prevent the migration of mercury.
Abdomen
;
Abdominal Pain
;
Diphtheria Toxoid
;
Epidural Space
;
Haemophilus Vaccines
;
Hair
;
Heart
;
Humans
;
Lung
;
Mercury Poisoning
;
Neck
;
Neck Pain
;
Needles
;
Postoperative Complications
;
Pulmonary Artery
;
Skull Base
;
Spinal Canal
;
Suicide
;
Young Adult

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