The goal of this study was to determine how much the formation of tetanus antibody is influenced after a single injection of tetanus vaccine (Td) and the simultaneous injection of tetanus vaccine with tetanus immunoglobulin (TIG). All of the healthy adult volunteers were divided into two groups: group 1 (Td only) and group 2 (Td plus TIG). Two hundred thirty seven volunteers were enrolled. When the baseline antibody titer, gender and age were adjusted, the geometric mean titers (GMTs) of the tetanus antibody (group 1 vs group 2) was 0.8438 IU/mL vs 0.5684 IU/mL at 4 weeks (P = 0.002), 0.4074 IU/mL vs 0.3217 IU/mL at 6 months (P = 0.072) and 0.3398 IU/mL vs 0.2761 IU/mL at 12 months (P = 0.140) after injection, respectively. The formation of tetanus antibody after tetanus vaccination is not influenced by TIG at the late period and in adults below the age of 50 yr, but there are significant differences between the two groups at the early period of 4 weeks after vaccination and for the patients over 60 yr.
Adult ; Age Factors ; Antibodies, Bacterial/blood ; Female ; Humans ; Immunoglobulins/*administration & dosage ; Male ; Middle Aged ; Sex Factors ; Tetanus/immunology/*prevention & control ; Tetanus Toxoid/*administration & dosage/immunology ; Time Factors

BACKGROUND: Point-of-care-testing (POCT) kits for tetanus toxoid antibody are used in emergency departments to evaluate the immunization status of patients with tetanus. The objective of this study was to evaluate the analytical performance and the utility of SD BIOLINE tetanus kit (Standard Diagnostic Inc., Yongin, Korea), as a POCT. METHODS: A total of 326 peripheral blood specimens (whole blood, 319; serum, 326) from healthy subjects and patients were used. SD BIOLINE tetanus kit was evaluated for precision, accuracy, effect of specimens, operator variance, and the total processing time. The results from SD BIOLINE tetanus kit were compared with those from 2 quantitative ELISA kits. RESULTS: Compared with ELISA kits, SD BIOLINE tetanus kit revealed a sensitivity of 88-97%, specificity of 87-92%, positive predictive value of 81-89%, negative predictive value of 90-98%, and kappa agreement of 0.78-0.82. SD BIOLINE tetanus kit also showed an excellent precision and a high accuracy. It showed a high concordance rate between whole blood and serum specimens. The total processing time of SD BIOLINE tetanus kit was 30-40 min. CONCLUSIONS: SD BIOLINE tetanus kit showed an excellent analytical performance. With its rapid turnaround time and the ease of handling and interpretation, SD BIOLINE tetanus kit seems appropriate for the evaluation of tetanus immunization status as a POCT device. However, education for operators and standardized guidelines for result interpretation should be emphasized.
Antibodies, Bacterial/blood ; Enzyme-Linked Immunosorbent Assay ; Humans ; Point-of-Care Systems ; *Reagent Kits, Diagnostic ; Reproducibility of Results ; Sensitivity and Specificity ; Tetanus/*diagnosis/prevention & control ; Tetanus Toxoid/*immunology

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

A meta-analysis was performed on the immunogenicity of Haemophilus influenzae type b (Hib) conjugate vaccines after 2 (2 and 4 months) and 3 doses (2, 4, and 6 months) in Korean infants. A database search of MEDLINE, KoreaMed, and Korean Medical Database was done. The primary outcome measure was the proportion of infants with anti-polyribosylribitol phosphate (PRP) concentrations > or =1.0 microgram/mL. Eight studies including eleven trials were retrieved. One trial reported on the diphtheria toxoid conjugate vaccine (PRP-D) and 2 trials each on the mutant diphtheria toxin (PRP-CRM) and Neisseria meningitidis outer-membrane protein (PRP-OMP) conjugate vaccine. Heterogeneity in study designs between trials on PRP-CRM was noted and one trial reported on a monovalent and another on a combination PRP-OMP vaccine. Thus, a meta-analysis was conducted only on the tetanus toxoid conjugate vaccine (PRP-T). After a primary series of 2 doses and 3 doses, 80.6% (95% confidence interval [CI]; 76.0-85.1%) and 95.7% (95% CI; 94.0-98.0%) of infants achieved an antibody level > or =1.0 microgram/mL, respectively. The immunogenic response to the PRP-T vaccine was acceptable after a primary series of 3 doses and also 2 doses. A reduced number of doses as a primary series could be carefully considered in Korean infants.
Antibodies/analysis ; Bacterial Capsules/*immunology/metabolism ; Haemophilus Vaccines/*immunology/metabolism ; Humans ; Infant ; Republic of Korea ; Tetanus Toxoid/chemistry/metabolism ; Vaccines, Conjugate/immunology/metabolism

OBJECTIVETo obtain highly purified tetanus toxin fragment C (TTC) with good immunogenicity.

METHODSThe gene fragment encoding TTC was amplified from Clostridium tetani plasmid DNA by PCR, inserted into the vector pET43.1a (+) and expressed in E. coli BL21(DE3)plysS. After purification using Ni2+-chelate affinity chromatography, the expressed fusion protein was digested by thrombin and the resultant TTC protein was purified with Ni2+-chelate affinity chromatography followed by identification with SDS-PAGE and Western blotting. The purifed TTC protein was then used to immunize mice to test its immunogenecity.

RESULTSThe 1373-bp gene fragment encoding TTC was obtained, and the constructed recombinant expression vector pET43.1a (+)-TTC was successfully expressed in E. coli BL21(DE3)plysS. SDS-PAGE identified a recombinant fusion protein with relative molecular mass (Mr) of 117 000, which accounted for 22% of the total bacterial protein. The TTC protein with Mr of 50 000 was obtained after purification of the thrombin digestion products of the fusion protein, with a purity reaching 95.5%. Both the fusion protein and TTC protein could be recognized by anti-tetanus toxin antibody as shown by Western blotting. The titer of the anti-serum from mice immunized with the TTC protein was 1:25 600, and the anti-serum could specifically bind to tetanus toxin.

CONCLUSIONHighly purified and immunogenetic TTC protein has been successfully obtained, which provides a good model antigen for studying antigen presentation and immune responses in vivo.

Cloning, Molecular ; Electrophoresis, Polyacrylamide Gel ; Escherichia coli ; genetics ; metabolism ; Genetic Vectors ; Peptide Fragments ; biosynthesis ; genetics ; immunology ; Recombinant Fusion Proteins ; biosynthesis ; genetics ; immunology ; Tetanus Toxin ; biosynthesis ; genetics ; immunology ; Tetanus Toxoid ; immunology

Spore surface display is one of attractive microorganism surface display systems. With the advantage of resistance attribute and specific assembly pattern, the technology of spore surface display now is attracting more and more attention. According to the current reports and main achievements of spore surface display, the structure and assembly of spores, the principle for construction and some existing spore surface display systems were elaborated in this paper. Now with the unique property of spores, the technique is not only widely used in production of vaccines but also has great applied potential in the field of biocatalysis and cell-factory.
Bacillus subtilis ; genetics ; metabolism ; Biocatalysis ; Biotechnology ; methods ; Gene Expression Regulation, Bacterial ; Genetic Engineering ; methods ; Recombinant Proteins ; genetics ; metabolism ; Spores, Bacterial ; genetics ; metabolism ; Tetanus Toxoid ; genetics ; immunology

In this study, a self-designed powder needleless injection system was compared with subcutaneous injection using a needle and syringe to deliver tetanus toxoid (TT) into mice to elicit immunity. First of all, factors influencing the prepartion of TT into powder by being absorbed on aluminium hydroxide were investigated and the micromeritic characters of Al (OH)3-TT powder were observed with optical microscope and laser particle analyzer. The results showed that salt concentration and absorption time had an enhancive effect on drug loading, but the pH value and temperature did not influence the absorption reaction obviously. The absorption reaction was optimized with sodium chloride concentration of 0.4 mol x L(-1) and lasting for 10 min. The average diameter of Al(OH)3-TT powder prepared with conditions optimized above was (60.6 +/- 4.4) microm. The immunization effect of TT was determined through enzyme-linked immunosorbent assay (ELISA) of the concentration of IgG antibody elicited by TT. With delivery of Al(OH)3-TT (of 30 microg TT) by powder needleless injection to mice, the IgG antibody concentration were (6.19 +/- 0.52) and (10.70 +/- 0.78) U x L(-1) after immunization of 4 and 8 weeks, respectively, while the values were (4.25 +/- 0.58) and (7.48 +/- 0.57) U x L(-1) by subcutaneous injection (of 20 microg TT) using a needle and syringe. The results suggested that the self-designed powder needleless injection of Al(OH)3-TT was comparable to subcutaneous injection with a good immunity.
Adjuvants, Immunologic ; administration & dosage ; Aluminum Hydroxide ; administration & dosage ; Animals ; Drug Compounding ; Female ; Immunoglobulin G ; blood ; Injections, Jet ; Male ; Mice ; Particle Size ; Powders ; Tetanus Toxoid ; administration & dosage ; immunology

The incidence of invasive diseases, including meningitis caused by Haemophilus influenzae type b (Hib) was markedly decreased after routine immunization of Hib vaccine through diverse schedules in many countries. The purpose of this study was to evaluate the immunogenicity and safety of Hib conjugate vaccines in Korean children before the implementation of a national immunization program against Hib in Korea. A multicenter controlled trial was performed on two different Hib vaccines in Korean children. A total of 319 infants were enrolled: 199 infants were immunized with the Hib polysaccharide conjugated to the tetanus toxoid (PRP-T) and 120 infants with the Hib polysaccharide conjugated to the outer-membrane protein of Neisseria meningitides (PRP-OMP). Immunogenicity was evaluated by enzyme-linked immunosorbent assay (ELISA) and serum bactericidal assay. Both vaccines showed good immunologic responses after primary immunization. After 2 doses of PRP-T or PRP-OMP, 78.9% and 91.7% of infants achieved an antibody level of > or = 1.0 microgram/mL, respectively. Both vaccines were safe and well-tolerated. No serious adverse events were observed. Thus, Hib conjugate vaccines appear to be safe and show good immunogenicity in Korean infants. These results will be important reference data for the implementation of Hib vaccine in the national immunization program of Korea.
Bacterial Outer Membrane Proteins/administration & dosage/*adverse ; Enzyme-Linked Immunosorbent Assay ; Haemophilus Vaccines/administration & dosage/*adverse effects/*immunology ; Haemophilus influenzae type b/*immunology ; Humans ; Infant ; Korea ; Polysaccharides, Bacterial/administration & dosage/*adverse effects/*immunology ; Tetanus Toxoid/administration & dosage/*adverse effects/*immunology