Since the implementation of conjugate Haemophilus influenzae serotype b (Hib) vaccine, the rate of infections caused by Hib has dramatically decreased, and the proportion of infections caused by non-type b H. influenzae has increased. Cerebral venous sinus thrombosis (CVST) is rare; however, it should be considered as a potential complication of bacterial meningitis. Herein, we report about a child who developed CVST after being diagnosed with H. influenzae serotype f meningitis.
Bacteremia ; Central Nervous System Infections ; Cerebrospinal Fluid ; Child ; Haemophilus influenzae type b ; Haemophilus influenzae ; Haemophilus ; Humans ; Influenza, Human ; Meningitis ; Meningitis, Bacterial ; Meningitis, Haemophilus ; Sepsis ; Serogroup ; Sinus Thrombosis, Intracranial

PURPOSE: Vaccine evaluation studies were initiated from 2000 by the Ministry of Food and Drug Safety to produce proper data about the safety and immunogenicity of vaccines. The purpose of this study was to review studies and reports on evaluation of vaccine such as immunogenicity, efficacy, effectiveness, safety and other related topics in order to find and analyze the data on the usefulness of each vaccine. METHODS: From 2000 to 2014, the project "The vaccine evaluation" had been performed by several researchers, and studies and reports of vaccine evaluation. We reviewed the results and outcomes of studies regarding the evaluation of vaccine's usefulness and analyzed the possibilities of applying these data for establishing vaccine policies. For each vaccine, data analysis and organization were done according to evaluation fields. RESULTS: A total of 83 studies were performed on vaccines from 2000 to 2014. For each vaccine, 8 studies were performed on BCG, 14 on DTaP/Td, 1 on poliovirus, 5 on Hib, 3 on pneumococcus, 11 on influenza, 3 on hepatitis A, 11 on MMR, 11 on varicella, and 16 on Japanese encephalitis. All studies were analyzed by the following evaluation area, such as safety, immunogenicity, seroprevalence, persistence of immunity, efficacy, effectiveness, vaccine evaluation methods, quality control product for vaccine, and others. CONCLUSIONS: Vaccine evaluation studies performed in Korea may be useful as references for establishing vaccination strategy and policy and could be used as baseline data for future studies on vaccine evaluation, vaccine policy establishment, and public/expert vaccine education in Korea.
Chickenpox ; Education ; Encephalitis, Japanese ; Haemophilus influenzae type b ; Hepatitis A ; Influenza, Human ; Korea* ; Mycobacterium bovis ; Poliovirus ; Quality Control ; Republic of Korea ; Seroepidemiologic Studies ; Statistics as Topic ; Streptococcus pneumoniae ; Vaccination ; Vaccines

<b>OBJECTIVEb>To analyze the occurrence feature of adverse events following immunization (AEFI) of Hib conjugate vaccine (HibCV) and to evaluate the safety of HibCV in postmarketing.

<b>METHODSb>2008-2013 HibCV AEFI data were collected through national AEFI information management system, which were downloaded in March 18, 2014.The demographic information and inoculation quantity of HibCV were from Immunization information management system in Jiangsu province. The incidence rate and 95% CI value of AEFI, common vaccine reaction and rare vaccine reaction following immunization of HibCV were calculated. The differences in the incidence rate of common vaccine reaction and rare vaccine reaction among sex, months of age, and number of injections were compared by means of (χ² tests.

<b>RESULTSb>A total of 6.16 million doses of vaccine were administered in Jiangsu province during 2008-2013, and 4 718 vaccinees reported having adverse event, for a rate of 76.60/100 000 (95% CI: 74.42/100 000-78.79/100 000). The incidence rate of common vaccine reaction and rare vaccine reaction was 71.10/100 000 (95% CI: 68.99/100 000-73.20/100 000) and 5.16/100 000 (95% CI: 4.60/100 000-5.73/100 000), respectively. The main symptoms of common vaccine reactions were fever, swelling, indurations and gastrointestinal reactions. The incidence rates of them were 40.54/100 000, 35.09/100 000, 12.94/100 000 and 0.36/100 000 in turn. The main symptoms of rare vaccine reactions were anaphylactic rashes and angioedema, the incidence rates of which were 4.77/100 000 and 0.15/100 000 respectively. 91.39% (4 002/4 379) of common vaccine reactions and 88.36% (281/318) of rare vaccine reactions happened within 1 d after vaccination. Anaphylactic shock (3 cases) and laryngeal edema (1 case) all happened within 1 d after vaccination. The incidence rate of common vaccine reactions among boys (79.72/100 000, 2 641/3 313 071) was higher than that of girls (61.07/100 000, 1 738/2 846 001) (χ² = 74.92, P < 0.001). The incidence rate of common vaccine reactions among children aged ≥ 12 month-old (86.82/100 000, 2 200/2 533 949) was higher than that among children aged 2-11 month-old (60.11/100 000, 2 179/3 625 123) (χ² = 149.79, P < 0.001). The incidence rate of common vaccine reactions in children vaccinated the first dose (78.93/100 000, 2 666/3 377 614) was higher than that in children vaccinated the second or third or fourth dose (61.59/100 000, 1 713/2 781 458) (χ² = 64.59, P < 0.001). The incidence rate of rare vaccine reactions in children vaccinated the first dose (6.69/100 000, 226/3 377 614) was higher than that in children vaccinated the second or third or fourth dose (3.31/100 000, 92/2 781 458) (χ² = 33.82, P < 0.001).

<b>CONCLUSIONb>The safety of HibCV among children was relative good. However, the surveillance should still focus on the anaphylactoid reactions of anaphylactic shock and laryngeal edema after HibCV immunization.

Angioedema ; Bacterial Capsules ; Child ; Female ; Fever ; Haemophilus Infections ; Haemophilus Vaccines ; adverse effects ; Haemophilus influenzae type b ; Humans ; Hypersensitivity ; Immunization ; Influenza, Human ; Male ; Safety ; Vaccination ; Vaccines, Conjugate

PURPOSE: PubMed is not only includes international medical journals but also has a registration site for the ongoing clinical trials, such as ClinicalTrials.gov, under the supervision of US National Institutes of Health. We analyzed current status of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. MATERIALS AND METHODS: As of October 2012, there are total of 72 trials found on registry of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. These trials were analyzed and classified by conditions of vaccine clinical trials, biologicals or drugs used in vaccine clinical trials, status of proceeding research, and list of sponsor and collaborators. RESULTS: Total 72 trials of vaccine clinical trials conducted by Korean investigators are classified by groups of infection (64 trials), cancer (4 trials), and others (4 trials). Infections group shown are as follows: poliomyelitis, pertussis, diphtheria, tetanus, and Haemophilus influenzae type b (10), influenza (9), human papillomavirus infection (8), pneumococcal vaccine (6), herpes zoster (4), smallpox (4), hepatitis B (4), etc. One trial of each in lung cancer, breast cancer, prostate cancer, and colorectal cancer are shown in cancer group. One trial of each in Crohn's disease, ulcerative colitis, renal failure, and rheumatoid arthritis are shown in other group. CONCLUSION: Vaccine clinical trials conducted by Korean investigators in ClinicalTrial.gov reflects the current status of Korean research on vaccine clinical trials at the international level and can indicate research progress. It is hoped that this aids the development of future vaccine clinical trials in Korea.
Arthritis, Rheumatoid ; Breast Neoplasms ; Colitis, Ulcerative ; Colorectal Neoplasms ; Crohn Disease ; Diphtheria ; Haemophilus influenzae type b ; Hepatitis B ; Herpes Zoster ; Humans ; Influenza, Human ; Korea ; Lung Neoplasms ; National Institutes of Health (U.S.) ; Organization and Administration ; Papillomavirus Infections ; Poliomyelitis ; Prostatic Neoplasms ; Renal Insufficiency ; Research Personnel ; Smallpox ; Tetanus ; Vaccines ; Whooping Cough

Antibody titers to vaccine-preventable diseases such as tetanus, polio, measles, mumps, and rubella decline within 1-10 years after allogeneic or autologous hematopoietic stem cell transplantation (SCT) if the recipient is not vaccinated. Vaccine-preventable diseases such as pneumococcal diseases, Haemophilus influenzae type b infections, influenza, measles, and varicella can pose an increased risk for SCT recipients. Therefore, after SCT, the recipients should be routinely revaccinated. Vaccination recommendations have previously been developed and published by the European Group of Blood and Marrow Transplantation and the Centers for Disease Control, by the Infectious Diseases Society of America, and by the American Society for Blood and Marrow Transplantation in 2009. Different epidemiologies and strategies have existed in Korea. In 2012, the Korean Society of Infectious Diseases published "Vaccination for Adult" describing the guidelines for vaccination, one of the chapters assigned for vaccination of SCT recipients. The present article reviews the current available vaccination strategies for SCT recipients, their family members, and healthcare workers, with the focus on recent Korean perspectives.
Americas ; Bone Marrow ; Centers for Disease Control and Prevention (U.S.) ; Chickenpox ; Communicable Diseases ; Delivery of Health Care ; Graft vs Host Disease ; Haemophilus influenzae type b ; Hematopoietic Stem Cell Transplantation ; Hematopoietic Stem Cells ; Humans ; Influenza, Human ; Korea ; Measles ; Mumps ; Poliomyelitis ; Rubella ; Stem Cell Transplantation ; Tetanus ; Transplants ; Vaccination

Diphtheria-Tetanus-acellular Pertussis Vaccines ; Haemophilus influenzae type b ; immunology ; Influenza Vaccines ; Vaccination ; methods ; Vaccines, Combined

Acute otitis media (AOM) and pneumonia are among the most common infectious diseases of children. Both are mucosal infections and share many common features such as etiological agents, pathogenesis and immunity. Influenza plays an important role in the pathogenesis of AOM and pneumonia. A vaccine against influenza may have substantial impact on these diseases during the influenza season. In clinical trials, influenza vaccine has reduced the incidence of AOM and pneumonia complicating influenza in children. However, the efficacy of vaccines has been controversial in children less than 2 years of age. Similarly, vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib), both common causes of AOM and pneumonia, have the potential to reduce the impact of disease. Clinical trials showed that the currently licensed 7-valent pneumococcal conjugate vaccine (PCV), administered during infancy, had an efficacy of 6-7% for the prevention of AOM, however, visits to the clinic for AOM were reduced by up to 20-30% after routine use in the U.S. Both Hib and PCVs have a proven effectiveness of >20% for prevention of radiologically confirmed pneumonia in children. The recently introduced pnuemococcal vaccine conjugated with protein D is expected to reduce AOM and pneumonia caused by non-typable H. influenzae, in addition to its effects on pneumococcal diseases. Considering their high incidence in children, recent achievements in the prevention of AOM and pneumonia with vaccines may have a significant economic and social impact.
Achievement ; Child ; Communicable Diseases ; Haemophilus influenzae type b ; Humans ; Incidence ; Influenza Vaccines ; Influenza, Human ; Otitis ; Otitis Media ; Pneumonia ; Seasons ; Social Change ; Streptococcus pneumoniae ; Vaccines

Haemophilus influenzae type b (Hib) has been one of the most common causes of invasive bacterial infections in the young children during the pre-vaccine era. The polysaccharide vaccine developed in the 1970s was composed of the capsular polysaccharide of Hib. The polysaccharide vaccine was not not effective in children younger than 2 years old those who are the highest risk group. In the 1980s, the protein conjugate vaccine was developed employing diphtheria toxoid, tetanus taxoid or outer membrane protein of Neisseria meningitidis as carrier proteins. The protein conjugate protein is highly effective in young infants. In countries where Hib conjugate vaccine is included in routine immunization, Hib disease is almost eradicated. The incidence and spectrum of Hib disease vary among different countries. The incidence of Hib diseases among Korean infants and young children is lower compared to those of western countries; the incidence of Hib meningitis in children under 5 years of age is around 10 per 100,000 per year, compared to around 50 in the United States and 20-30 in the European countries. Immunogenicity of Hib vaccine in Korean infants is very good and the responsiveness of Korean infants to Hib vaccine vaccine is better than that of the U.S. infants, which may has implication for the apparently lower incidence of Hib disease in Korean children. Hib vaccine was introduced in the early 1990s, and has been recommended for high risk children and used as an optional vaccine among healthy infants. Hib vaccine is not included in the National Immunization Program yet, but the Committee on Infectious Disease, Korean Pediatric Society, have decided to include the Hib vaccine in the routine immunization program in 2008. Hib vaccine should be included in the National Immunization Program in the near future and a surveillance system for Hib disease should be established.
Bacterial Infections ; Carrier Proteins ; Child ; Communicable Diseases ; Diphtheria Toxoid ; Haemophilus ; Haemophilus influenzae ; Haemophilus influenzae type b ; Humans ; Immunization ; Immunization Programs ; Incidence ; Infant ; Influenza, Human ; Membrane Proteins ; Meningitis ; Neisseria meningitidis ; Tetanus ; United States

In 2007, the Korean Society of Infectious Diseases recommended an immunization schedule for adults residing in Korea. This recommendation includes four categories: standard immunization for healthy persons, supplementary immunization for persons with underlying illnesses, recommendations for health-care personnel and for international travelers. The Standard Immunization Schedule consists of universal vaccination (tetanus-diphtheria/tetanus-diphtheria-pertussis (Td/Tdap); hepatitis A vaccine for persons aged 20s; human papilloma virus vaccine for women under 26 years old; meningococcal vaccine for military recruits and college students in dormitories; influenza vaccination for persons aged 50 years or more and pregnant women; and pneumococcal vaccination for persons aged 65 years or more) and catch-up vaccination (hepatitis A vaccine for persons aged 30s; hepatitis B vaccine, varicella and MMR vaccines for persons who have uncertain specific immunities). The Supplementary Immunization Schedule recommends 4 vaccines, i.e., pneumococcal, influenza, meningococcal, and Haemophilus influenzae type b, appropriate to the underlying illnesses, and confirmation of the presence of antibodies to hepatitis A and hepatitis B. The Recommendation for Health-Care Personnel includes universal vaccination (influenza and pertussis) and catch-up vaccination (hepatitis B, measles-mumps-rubella and varicella for seronegative health-care personnel). The Recommended Immunization for International Travelers focuses reinforcement of vaccinations for healthy persons and includes certain immunizations necessary for international travel (yellow fever, meningococcal, plaque, tick-borne encephalitis, and cholera). These guidelines can be seen at www.ksid.or.kr.
Adult ; Aged ; Antibodies ; Chickenpox ; Collodion ; Communicable Diseases ; Encephalitis, Tick-Borne ; Female ; Fever ; Haemophilus influenzae type b ; Hepatitis A ; Hepatitis A Vaccines ; Hepatitis B ; Hepatitis B Vaccines ; Humans ; Immunization ; Immunization Schedule ; Influenza, Human ; Korea ; Meningococcal Vaccines ; Military Personnel ; Papilloma ; Reinforcement (Psychology) ; Vaccination ; Vaccines ; Viruses

In 2007, the Korean Society of Infectious Diseases recommended an immunization schedule for adults residing in Korea. This recommendation includes four categories: standard immunization for healthy persons, supplementary immunization for persons with underlying illnesses, recommendations for health-care personnel and for international travelers. The Standard Immunization Schedule consists of universal vaccination (tetanus-diphtheria/tetanus-diphtheria-pertussis (Td/Tdap); hepatitis A vaccine for persons aged 20s; human papilloma virus vaccine for women under 26 years old; meningococcal vaccine for military recruits and college students in dormitories; influenza vaccination for persons aged 50 years or more and pregnant women; and pneumococcal vaccination for persons aged 65 years or more) and catch-up vaccination (hepatitis A vaccine for persons aged 30s; hepatitis B vaccine, varicella and MMR vaccines for persons who have uncertain specific immunities). The Supplementary Immunization Schedule recommends 4 vaccines, i.e., pneumococcal, influenza, meningococcal, and Haemophilus influenzae type b, appropriate to the underlying illnesses, and confirmation of the presence of antibodies to hepatitis A and hepatitis B. The Recommendation for Health-Care Personnel includes universal vaccination (influenza and pertussis) and catch-up vaccination (hepatitis B, measles-mumps-rubella and varicella for seronegative health-care personnel). The Recommended Immunization for International Travelers focuses reinforcement of vaccinations for healthy persons and includes certain immunizations necessary for international travel (yellow fever, meningococcal, plaque, tick-borne encephalitis, and cholera). These guidelines can be seen at www.ksid.or.kr.
Adult ; Aged ; Antibodies ; Chickenpox ; Collodion ; Communicable Diseases ; Encephalitis, Tick-Borne ; Female ; Fever ; Haemophilus influenzae type b ; Hepatitis A ; Hepatitis A Vaccines ; Hepatitis B ; Hepatitis B Vaccines ; Humans ; Immunization ; Immunization Schedule ; Influenza, Human ; Korea ; Meningococcal Vaccines ; Military Personnel ; Papilloma ; Reinforcement (Psychology) ; Vaccination ; Vaccines ; Viruses