TD vaccine was produced on semi industrial scale at National Institute of Vaccine Da Lat – Nha Trang. 13 lots of biopreparations had met the safe and efficace criterion of WHO and of National Centre of quality control. Tetanos component reached the mean value of 157.08 IU/ml  42.36 and diphteria component – 37.00 IU/ml  9.3. The vaccine has been examining in human
Diphtheria ; Tetanus ; Diphtheria Toxoid

Diphtheria-tetanus-acellular pertussis (DTaP) vaccination must currently be administered three times starting at 2 months of age, at intervals of two months, with the first and second boosters administered at 15 to 8 months and 4 to 6 years of age. A high rate of vaccination is maintained, but studies of the efficiency and safety of booster vaccination are lacking. This study evaluated the immunogenicity and safety of the DTaP booster vaccine. Seventy-two infants who had been vaccinated with the first booster and 78 children who had been vaccinated with the second booster were enrolled in this study. Local and systemic adverse reactions after vaccination were recorded. Sera obtained before and 1 month after booster vaccination were analyzed for antibodies to diphtheria and tetanus toxoid, and anti-pertussis toxin. Diphtheria: The GMT was increased. Tetanus: The geometric mean antibody titer (GMT) was increased. Pertussis: The GMT was increased by 13.72 times and 14.37 times after the first and the second additional vaccination, respectively. Although the seroconversion rate was low prior to the first booster, the average amount of anti-pertussis toxin antibodies before the first additional vaccination was 143.37 EU/mL, which rose to 261.88 EU/mL after the vaccination. The seroconversion rate also increased to 100%. Adverse reactions showed spontaneous resolution within a few days after vaccination. After the second additional vaccination, there was a statistically significant increase in the manifestation of myalgia compared to after the first additional vaccination. In conclusion, DTaP booster vaccination was effective in Korean children, demonstrating that modifications to the current regimen would be unnecessary.
Antibodies ; Child ; Diphtheria ; Diphtheria-Tetanus-acellular Pertussis Vaccines ; Humans ; Immunization, Secondary ; Infant ; Tetanus Toxoid ; Vaccination ; Whooping Cough

The IVAC in-house reference for diphtheria vaccine has an average dry weight of 51.18 mg/ampoule, 2.85% moisture content (standard 3%). The reference vaccine kept at -20oC for 60 months still remains stable with 333.84 IU/ampoule. Kept at 37oC for 1, 2, 4, 6 and 8 weeks still remains stable. Potency of diphtheria component of DPT vaccine controlled by in-house reference vaccine and international standard vaccine gave the same results.
Diphtheria Toxoid ; vaccines

Since a nationwide childhood vaccination with tetanus toxoid, tetanus has become a rare disease in Korea. However, we recently experienced 17 cases of adult tetanus in a university hospital during a 21-month period. Seventy percent of the patients were female, and the mean age was 63 yr (range, 29-87). The majority (88.2%) of the patients did not get primary vaccinations for tetanus and decennial tetanus-diph-theria toxoid booster. Most patients (88.2%), who sustained acute injury, did not seek medical care for their wounds or did not receive the prophylaxis for tetanus. Tetanus was found most frequently among farmers. Tetanus was diagnosed initially only in 53% of patients. The case-fatality ratio was 23.5%. These cases show that recently occurring tetanus in Korea is a disease, affecting the elderly and the female who may have a lower immunity against tetanus, and the farmers who are likely to be exposed to Clostridium tetani. In addition, diagnosis of tetanus is often delayed in area where cases are seen infrequently. Therefore, improved education among patients and physicians, emphasis of anti-tetanus immunization and awareness of tetanus respectively, may be essential for the prevention of disease and the reduction of its mortality.
Adult ; Aged ; Aged, 80 and over ; Agricultural Workers' Diseases/epidemiology ; Diagnostic Errors ; Diphtheria-Tetanus-Pertussis Vaccine ; Emergency Service, Hospital ; Health Education ; Health Knowledge, Attitudes, Practice* ; Human ; Immunization, Secondary/psychology ; Immunization, Secondary/utilization* ; Korea/epidemiology ; Middle Aged ; Tetanus/diagnosis ; Tetanus/epidemiology* ; Tetanus/prevention & control ; Tetanus/therapy ; Tetanus Antitoxin/therapeutic use ; Tetanus Toxoid ; Treatment Outcome ; Vaccination/utilization* ; Wounds, Penetrating/complications

This study was conducted to evaluate the immunogenicity and safety of diphtheria-tetanus (Td) vaccine in adults over 40 yr old who had never received a diphtheria-tetanus-pertussis (DTP) vaccination. A total of 242 subject completed three-doses of Td vaccination and subsequent assays for immunogenicity. Before vaccination, 33.9% and 96.7% participants showed antibody levels of diphtheria and tetanus, respectively, which were below protective level (<0.1 U/mL). After the first dose of Td vaccine, 92.6% and 77.6% of subjects gained protective antibody concentrations (> or =0.1 U/mL) for diphtheria and tetanus, with an increase to 99.6% and 100% after the third dose. Local and systemic adverse events occurred in 37.9% and 15.5% of the subjects. No serious adverse event requiring an unscheduled hospital visit occurred. In conclusion, three-doses of Td vaccination to unimmunized adults are safe and effective in inducing protective immunity against diphtheria and tetanus.
Adult ; Aged ; Aged, 80 and over ; Antibodies, Bacterial/blood ; Diphtheria/prevention & control ; Diphtheria-Tetanus Vaccine/*adverse effects/*immunology ; Female ; Humans ; Immunization, Secondary ; Male ; Middle Aged ; Tetanus/prevention & control ; Tetanus Toxoid/immunology

PURPOSE: This study was undertaken to evaluate the immunogenicity and reactogenicity of Td booster immunization in early preadolescents of Korea. METHODS: Healthy preadolescents, who had been vaccinated with 4 or 5 doses of DTaP vaccines until 6 years old age, were enrolled in this study from August 2006 to April 2007 . Diphtheria and tetanus anti-toxoid antibodies in sera were measured by ELISA just before vaccination and 4 weeks after vaccination to evaluate immunogenicity. Local and systemic adverse reactions observed for 4 weeks after vaccination to access reactogenicity. RESULTS: 183 preadolescents were enrolled and mean age was 11.40+/-0.51 years old. All subjects achieved seroprotective diphtheria and tetanus anti-toxoid antibodies (titers > or =0.1 IU/mL) after Td booster vaccination. Among 183 vaccinees, 73.8% showed local adverse reactions and 37.2% systemic adverse reactions. Pain at injection site (66.1%) was the most common local reaction, and the most commonly shown systemic reaction was myalgia (17.5%). The adverse reactions were spontaneously relieved within three days after vaccination. CONCLUSION: Td vaccine in this study was high immunogenic and showed an acceptable tolerance in Korean preadolescents. Td booster vaccination at 11 -12 years old is the most effective method to increase compliance of the vaccination and to decrease the incidence of diphtheria and tetanus.
Aged ; Antibodies ; Compliance ; Diphtheria ; Diphtheria-Tetanus Vaccine ; Diphtheria-Tetanus-acellular Pertussis Vaccines ; Enzyme-Linked Immunosorbent Assay ; Humans ; Immunization ; Immunization, Secondary ; Incidence ; Korea ; Tetanus ; Vaccination

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*

Although tetanus and diphtheria have become rare in developed countries, pertussis is still endemic in some developed countries. These are vaccine-preventable diseases and vaccination for adults is important to prevent the outbreak of disease. Strategies for tetanus, diphtheria, and pertussis vaccines vary from country to country. Each country needs to monitor consistently epidemiology of the diseases and changes vaccination policies accordingly. Recent studies showed that tetanus–diphtheria–acellular pertussis vaccine for adults is effective and safe to prevent pertussis disease in infants. However, vaccine coverage still remains low than expected and seroprevalence of protective antibodies levels for tetanus, diphtheria, and pertussis decline with aging. The importance of tetanus–diphtheria–acellular pertussis vaccine administration should be emphasized for the protection of young adult and elderly people also, not limited to children.
Adult* ; Aged ; Aging ; Antibodies ; Child ; Developed Countries ; Diphtheria ; Diphtheria-Tetanus-acellular Pertussis Vaccines ; Epidemiology ; Humans ; Infant ; Pertussis Vaccine ; Seroepidemiologic Studies ; Tetanus ; Vaccination* ; Vaccines ; Whooping Cough* ; Young Adult

Objective: To analyze the dropout of adsorbed diphtheria, tetanus and acellular pertussis combined vaccine (DTaP) routine immunization in China in 2019. Methods: DTaP vaccination data in all counties in China were collected through National Immunization Program Information Management System in 2019. Cumulative dropout rate and vaccination rate of DTaP in different provinces were calculated. According to the P₂₅, P₅₀ and P₇₅ values of DTaP dropout rate for all counties by province, counties in each province were divided into four groups (Q₁-Q₄). The DTaP average dropout rate of four groups and absolute difference (difference in DTaP average dropout rate between Q₄ and Q₁) were calculated. Spearman rank correlation was used to analyze the relationship between absolute difference and provincial DTaP dropout rate, DTaP₁ and DTaP₃ vaccination rate. Results: DTaP₁ vaccination rate ranged from 92.98% to 99.94% by province, with a median of 99.55%. Provincial DTaP dropout rate ranged from 0.36% to 28.66%, with a median of 3.54%. The provincial DTaP dropout rate was more than 10% in Gansu and Guizhou, about 28.66% and 17.19%. Absolute difference ranged from 4.02% to 39.22%, with a median of 10.16%. Provinces with the largest absolute difference were Gansu, Qinghai, Liaoning and Guizhou, about 39.22%, 34.48%, 23.31% and 21.33%, respectively. Correlation analysis indicated that the absolute difference was positively correlated with provincial DTaP dropout rate, with a correlation coefficient of 0.492 (P=0.004). It was negatively correlated with DTaP₁ and DTaP₃ vaccination rate. Correlation coefficients were -0.542 (P=0.001) and -0.562 (P=0.001), respectively. Conclusions: There are significant county-level differences in DTap dropout rate in most provinces, with relatively high difference in western provinces.
Humans ; Infant ; Whooping Cough/prevention & control* ; Diphtheria-Tetanus-Pertussis Vaccine ; Diphtheria-Tetanus-acellular Pertussis Vaccines ; Vaccination ; China ; Immunization, Secondary ; Immunization Schedule ; Antibodies, Bacterial

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