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

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

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

An attempt has been made to evaluate diphtheria and tetanus antitoxin response to diphtheria and tetanus toxoid as pressently marketed in Korea. A total of 80 infants divided in two groups according to doses of vaccine, were studied One group of 30 infants (group I ) received 1, 2 or 3 doses of D. P. T. vaccine (0.3ml, each) at approximately monthly interval. 1) In control group of 19 infants not immunized, the protective level of diphtheria antitoxin was found in 36.8% of infants, and the protective level of tetanus antitoxin was found in 5.3% of infants. These finding suggested the antitoxin level which was passively transmitted from the mother. 2) The frequency of diphtheria and tetanus vaccination correlates with antitoxin level, but there was no difference in antitoxin response between group I or group 11. 3) The antitoxin response were more excellant in infants given same dose of vaccine divided into multiple dose. 4) In both group I and 11, 100% of infants achieved protective level of diphtheria (0.03u/ml) and tetanus antitoxin (0.1u/ml) after 3 primary vaccination.
Diphtheria Antitoxin ; Diphtheria* ; Humans ; Infant ; Korea ; Mothers ; Tetanus ; Tetanus Antitoxin ; Tetanus Toxoid ; Vaccination

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

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

Biofilms are well-organized, complex microbial communities that are often highly resistant to antimicrobial agents and host defenses. Biofilms are often formed on the surfaces of surgical implants and indwelling catheters. Being extremely resistant to removal, biofilms, once formed, cause numerous complications and often result in persistent infections that require long-term hospitalization for treatment. Until now, preventive measures employing prophylactic antimicrobials that prohibit or restrict biofilm formation have been the only feasible, effective options available, with the constant concomitant threat of antimicrobial resistance. However, the development of chemical agents that specifically act upon the virulence of biofilms, rather than destroying the microorganisms or suppressing their growth, is a promising new approach. Such agents are highly desirable in that they might allow clinicians to prevent the development of antimicrobial resistance. Effective suppression of biofilm formation would dramatically change the way to treat infectious disease. In this literature review, the types of infections associated with biofilms and relevant therapeutic options that have been approved, in use, or under development to treat biofilm infections are discussed, along with novel approaches to biofilm control that may be applicable to the development of future anti-biofilm agents.
Anti-Infective Agents ; Biofilms ; Catheters, Indwelling ; Communicable Diseases ; Diphtheria Toxoid ; Haemophilus Vaccines ; Hospitalization

Imaging assessment of prostate cancer is one of the most difficult sections of oncology imaging. Detecting, localizing and staging of the primary prostate cancer by preoperative imaging are still challenging for the radiologist. Magnetic resonance (MR) imaging provides excellent soft tissue contrast and is widely used for solid organ imaging, but results of preoperative imaging of the prostate gland with conventional MR imaging is unsatisfactory. Positron emission tomography and computed tomography (PET/CT) is the cornerstone in oncology imaging, but some limitations prohibit the assessment of primary prostate cancer with PET or PET/CT. Recent studies to overcome these insufficient accuracies of imaging evaluation of primary prostate cancers with advanced MR techniques and PET and PET/CT are reported. In this article, we review the imaging findings of prostate cancer on variable modalities, focused on MR imaging and PET/CT.
Diphtheria Toxoid ; Haemophilus Vaccines ; Magnetic Resonance Spectroscopy ; Positron-Emission Tomography and Computed Tomography ; Prostate ; Prostatic Neoplasms

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

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