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PubMed1995

[Determination of tetanus antitoxin levels in human immunoglobulins for intravenous use and in tetanus immunoglobulins by enzyme linked immunosorbent assay]

The present European Pharmacopoeia monograph for human tetanus immunoglobulin specifies that the estimate of potency has to be performed in guinea pigs or mice. In the course of the state control of such products we have so far used the potency test in mice. Aimed at a reduction of the numbers of animals used for testing tetanus potency of immunoglobulins in the course of official batch release we have used the enzyme linked immunosorbent assay (ELISA). 51 batches of 19 different immunoglobulin preparations of 10 manufacturers were included. Almost all tetanus immunoglobulins contained more than 250 I.U. of tetanus antitoxin per millilitre as agreed with manufacturers during marketing authorization negotiations in Germany. Normal human immunoglobulins for intravenous use had - depending on individual products - lower and fluctuating tetanus antitoxin titers. However, some of them fulfil the Ph. Eur. Monograph requirement of not less that 50 I.U./ml. The question is raised whether such products could be useful in treatment of persons with view to their immediate bioavailability, whenever the antitoxin titer is stated in particular on the package inserts. Our titration results were reliably reproducible. We have drawn the conclusion that we can largely renounce at animal tests when determining tetanus antitoxin potency in immunoglobulins.

Journal Article↗
PubMed1990

Tetanus antitoxin binds to intracellular tetanus toxin in permeabilized chromaffin cells without restoring Ca2(+)-induced exocytosis.

Tetanus toxin blocks Ca2(+)-evoked catecholamine release from permeabilized bovine adrenal chromaffin cells preloaded with gangliosides. Tetanus toxin preincubated with its specific antibodies F(ab')2 is without any effect on exocytosis. Specific antitetanus F(ab')2 presented to chromaffin cells which are pretreated with tetanus toxin and permeabilized by digitonin cannot restore exocytosis. Under the same conditions, however, 125I-labeled F(ab')2 accumulates in chromaffin cells. The accumulation depends on the presence and concentration of tetanus toxin and can be prevented by an excess of unlabeled F(ab')2. Once tetanus toxin has initiated block of exocytosis, it cannot be neutralized by binding to its specific antibody.

Animals↗
PubMed2006

An adolescent-adult formulation tetanus and diptheria toxoids adsorbed combined with acellular pertussis vaccine has comparable immunogenicity but less reactogenicity in children 4-6 years of age than a pediatric formulation acellular pertussis vaccine and diphtheria and tetanus toxoids adsorbed combined with inactivated poliomyelitis vaccine.

In Canada, the fifth dose of the routine childhood immunization schedule against diphtheria, tetanus, pertussis and polio is given at 4-6 years of age. Up to 30% of children may have significant local reactions (redness, swelling) and this may be related to pertussis and diphtheria antigen content. We sought to determine if a combination product with lower content of pertussis and diphtheria toxoids (dTap) would result in fewer local reactions and not have inferior immunogenicity to a combination vaccine with higher pertussis and diphtheria content (diphtheria-tetanus-acellular pertussis-inactivated polio virus, DTaP-IPV). Healthy children aged 4-6 years with complete primary immunization series and a fourth dose of diphtheria and tetanus toxoids component pertussis inactivated polio and Haemophilus influenzae type B conjugate vaccine were randomized to one dose of dTap, followed in 4-6 weeks by one dose of IPV or control DTaP-IPV. Immediate reactions within 30 min, solicited injection site and systemic reactions within 14 days, and unsolicited adverse events (AE) within 6 weeks post-vaccination were monitored. Serum was collected prior to immunization, and 4-6 weeks after vaccine for diphtheria, tetanus and pertussis antibodies (Ab). Sample size was designed to detect > or =10% difference in injection site erythema, pain or swelling between groups 593 children at eight Canadian sites completed the study; no participant withdrew because of an AE. All safety endpoints on days 0-14 were less frequent in children randomized to the dTap than DTaP-IPV group: erythema (34.6% versus 51.7%), swelling (24.2% versus 33.8%) and pain (39.6% versus 67.2%). Fever was also less common (8.72% versus 16.9%). All children in both study groups had seroprotective Ab levels to diphtheria and tetanus at 4-6 weeks (> or =0.10 IU/mL). The majority of children in each vaccine arm had a four-fold increase in pertussis antibodies. Fever and injection site reactions are less common in 4-6 year-old-children who receive a dTap vaccine compared to DTaP-IPV, without inferior immunogenicity.

Child↗
PubMed1999

Lymphocyte response to tetanus toxin T-cell epitopes: effects of tetanus vaccination and concurrent malaria prophylaxis.

Synthesized T-cell epitopes of tetanus toxin are universally immunogenic and serve to enhance immune response when they are used as vaccine carriers of B-cell epitopes. The immunogenicity of the P2, P30, and P2P30 T-cell epitopes of tetanus toxin and whole tetanus toxoid (TT) was evaluated by in vitro proliferation assay of lymphocytes from men with no history of tetanus vaccination who were enrolled in a malaria prophylaxis trial. The enhancement of immune response by tetanus vaccination (Td) and possible antagonism by the antimalarial drugs, was measured by pre- and post-Td comparisons within and between immunized prophylaxis groups (primaquine, chloroquine, placebo) and a nonimmunized control group. Constructs demonstrated low immunogenicity relative to TT in all groups. Relative to both control and its own baseline, the immunized primaquine prophylaxis group was distinct in demonstrating significantly increased proliferation against all three subunits and at both high (30 microg ml(-1)) and low (3 microg ml(-1)) concentrations. Immunization elicited significantly increased proliferation responses by placebo and chloroquine prophylaxis groups against only the P2P30 construct. Despite these significant post-Td changes, a low concentration of TT 0.1 microg ml(-1)) stimulated proliferation 7-10 times over that induced by the greatest concentration of the constructs.

Adult↗
PubMed1994

Safety and immunogenicity of Haemophilus influenzae vaccine (tetanus toxoid conjugate) administered concurrently or combined with diphtheria and tetanus toxoids, pertussis vaccine and inactivated poliomyelitis vaccine to healthy infants at two, four and six months of age.

The safety and immunogenicity of Haemophilus influenzae vaccine (tetanus toxoid conjugate (PRP-T) administered concurrently in separate sites or mixed in the same syringe with diphtheria and tetanus toxoids, pertussis vaccine and inactivated poliomyelitis vaccine were assessed in 439 infants at 2, 4 and 6 months of age. The proportions with local redness, tenderness and swelling in the separate and combined groups were 18% vs. 11% (P < 0.001), 27% vs. 24% and 15% vs. 13%, respectively. Systemic reactions occurred at similar rates in both groups. The combined vaccine induced tetanus and diphtheria antitoxin titers > or = 0.01 IU/ml in 99.5 and 99.1% of infants, pertussis agglutinin titers > or = 64 in 92.4%, anti-polyribosylribitol phosphate titers > or = 0.15 microgram/ml in 93.8% and > or = 1.0 microgram/ml in 75% and polio-neutralizing titers > or = 8 in > 98% of infants. However, antibody concentrations to PRP-T, some pertussis antigens and tetanus toxoid were significantly lower after combined than after separate injections of DPT/diphtheria and tetanus toxoids, pertussis vaccine and inactivated poliomyelitis vaccine and PRP-T. The clinical significance of these differences is not known, but the interactions observed among the components of the pentavalent vaccine may be of concern because they might influence antibody persistence until the fourth dose is administered.

Diphtheria-Tetanus-Pertussis Vaccine↗
PubMed2000

[Antibody levels for diphtheria, tetanus and pertussis in young adult females immunized with whole cell pertussis-diphtheria-tetanus toxoid vaccine in infancy].

Antibody levels for diphtheria, tetanus and pertussis in 84 young adult females were measured. They had been immunized with whole cell pertussis-diphtheria-tetanus toxoid (DTwP) vaccine as a routine immunization in their infancy. Their history of DTwP vaccination were confirmed in their Maternal and Child Health Handbook, which includes their immunization record. Among the 84 cases, 4 cases (4.7%) had been immunized with the first dose of DTwP, 5 cases (6.0%) with the second dose, 23 cases (27.4%) with the third dose and 52 cases (61.9%) with the fourth dose. Of the 84 cases, 89.3% had received DTwP vaccine more than the third dose. In the 15-19 years after the last DTwP vaccination, the antibody positive rate for diphtheria and tetanus (> or = 0.01 IU/ml) were 86.9% and 94.0%, respectively. On the other hand, antibody positive rate for anti-pertussis toxin (anti-PT) and anti-filamentous hemaggulutinin (anti-FHA) (> or = 10 EU/ml) were 35.7% and 55.9%, respectively. The positive rate for pertussis compared with those for diphtheria and tetanus were lower. These findings suggested that DTwP vaccination in infancy does not provide sufficient immunity for young adults against pertussis, but DTwP vaccination provides adequate immunity against diphtheria and tetanus.

Adult↗
PubMed1987

Immunization of mice against tetanus with fragments of tetanus toxin synthesized in Escherichia coli.

Two recombinant plasmids, pTet11 and pTet18, which express nontoxic protein fragments of tetanus toxin in Escherichia coli, were constructed. pTet11 protein (86 kilodaltons) is a fusion between part of the E. coli trpE protein and 441 amino acids of tetanus fragment C, and pTet18 (63 kilodaltons) consists of part of fragment B and all of fragment C of tetanus toxin. The synthesis of these proteins was induced in E. coli cultures, and the proteins were partially purified. Mice were immunized with these proteins, and dose-dependent titers of anti-tetanus toxoid antibodies were obtained. The proteins were able to induce neutralizing antibodies in mice, as demonstrated by the ability of mice immunized with 1 microgram or more of protein to survive challenge with 10 50% lethal doses of tetanus toxin.

Animals↗
PubMed1990

Neonatal tetanus in babies of women immunized with tetanus toxoid during pregnancy.

In a study of 52 cases of neonatal tetanus admitted to Wesley Guild Hospital, Ilesha, it was found that 17 (33%) of the babies were delivered to mothers who had received adequate tetanus toxoid immunization during pregnancy. The 17 babies were compared with the remaining 35 babies whose mothers had not received tetanus prophylaxis. The case fatality rates in these two groups were 12.5% and 60% respectively (P less than 0.01). This report shows that neonatal tetanus can occur in babies of mothers who were immunized with tetanus toxoid during pregnancy. Maternal immunity may, however, improve the prognosis in such infants.

Female↗
PubMed1999

Tetanus antibodies measured by the toxin binding inhibition test (ToBI) in mothers and children in the Neonatal Tetanus Program in Vietnam.

The immunoresponse to vaccination in the Neonatal Tetanus Program (NNT) for pregnant women was studied in Vietnam using the Toxin Binding Inhibition Test (ToBI). The vaccination schedule consisted of two primary doses of adsorbed tetanus toxoid (TT) vaccine given with a one month interval. The seroconversion rate in the women was 98%. Two and a half months after birth, 63% of the children born from these women had tetanus antibody values higher than 0.01 IU/ml. Four women who had anti-tetanus titres < 0.01 IU/ml at delivery, despite two doses of primary vaccination, received a third booster with vaccine one year after the first injection. Their antibody levels were well above 0.01 IU/ml one month after this additional booster, suggesting that (when economically feasible) a third TT injection could be considered into the NNT to confer optimal anti-tetanus antibody levels in women for subsequent pregnancies. This study confirmed the effectiveness of the TT vaccines investigated and indicates their potential to replace, in immunosurveillance studies under field conditions, the in vivo mouse neutralisation test by in vitro alternative methods such as the ToBI test.

Adult↗
PubMed1984

[Guinea pig resistance to infection by the spores of the tetanus causative agent at various levels of tetanus antitoxin and delayed hypersensitivity].

Comparative experimental investigations on guinea pigs immunized against tetanus, carried out with the use of different methods for the determination of immunity to tetanus, have demonstrated the existence of a relationship between the results of the tests used in these investigations (the neutralization test, the passive hemagglutination test and the allergic skin test) and the resistance of the animals to challenge with C. tetani spores in Dcl and Dlm50. The mechanisms of not only humoral, but also cell-mediated immunity play an important role in protection from tetanus infection. The possibility of using, on principle, the allergic skin test with tetanin for the evaluation of immunity to tetanus in individual patients with the aim of differential approach to protection against tetanus in traumas has been shown.

Allergens↗
PubMed1980

Treatment of tetanus by lumbar intrathecal tetanus-antitoxin.

The use of human tetanus antitoxin by lumbar intrathecal injection for the treatment of tetanus in five consecutive cases is reported. The intrathecal administration of human tetanus antitoxin as part of treatment appears to be the most effective treatment of tetanus and should be given as soon as the diagnosis of tetanus is established. The dose of antitoxin does not relate with the rapid improvement of muscle spasm.

Child, Preschool↗
PubMed1994

Prenatal tetanus immunization and other practices associated with neonatal tetanus.

The relationship between neonatal tetanus (NT) on one hand, and maternal tetanus immunization and other prenatal and natal practices on the other hand, was examined in a case-control study done at San Lazaro Hospital (SLH) in Manila from late 1990 to mid 1991. Included as cases were 54 patients diagnosed as NT on the basis of WHO criteria, and 50 controls who were patients 0-4 months of age, hospitalized at SLH during the study period and with no past history of tetanus. The result showed that the following were statistically associated with the risk of NT: home delivery (OR = 30.5); delivered by a traditional birth attendant (OR = 5.2); use of instrument other than scissors to cut the cord (OR = 19.3); traditional birth attendant who dressed the cord (OR = 12.7); and having less than two doses of tetanus toxoid (OR = 15.3). The need to intensify prenatal tetanus immunization, health education of the mothers as well as the training of birth attendants is evident from this study if NT has to be prevented.

Case-Control Studies↗
PubMed2000

Immunogenicity and safety of a trivalent tetanus, low dose diphtheria, inactivated poliomyelitis booster compared with a standard tetanus, low dose diphtheria booster at six to nine years of age. Munich Vaccine Study Group.

OBJECTIVE: To compare the immunogenicity and safety of a trivalent tetanus-diphtheria (low toxoid content)-inactivated poliomyelitis vaccine, Td-IPV (Revaxis; Pasteur Merièux), with a tetanus-diphtheria (low toxoid content) vaccine, Td (Td-Impfstoff Mérieux; Pasteur Merièux), when administered as a booster to children age 6 to 9 years. METHODS: A group of 301 children were randomized and vaccinated with Td-IPV (n = 150) or Td (n = 151) in this open, controlled, multicenter trial. Serum specimens were obtained before and 28 days after vaccination. Safety was assessed for up to 28 days postvaccination by parental diary cards. Solicited local and systemic reactions were recorded for 7 days after vaccination. RESULTS: Seroprotection (enzyme-linked immunosorbent assay titer, > or =0.10 IU/ml) against tetanus and diphtheria was induced by either Td-IPV or Td in all subjects. Tetanus and diphtheria geometric mean titer were higher after Td (34.0 and 5.74 IU/ml) than after Td-IPV (15.9 and 4.38 IU/ml). All subjects boosted with Td-IPV were seroprotected against each type of poliovirus (neutralizing antibody titer, > or =5/dilution). The most frequently reported solicited local and systemic symptoms were pain triggered by movement of the arm (54% vs. 39.1%) and headache (17.3% vs. 7.3%), after Td-IPV and Td, respectively. All other events were similar between the two groups. Reactions were generally mild and all were temporary. CONCLUSIONS: A booster dose of Td-IPV induced in all children seroprotection against tetanus, diphtheria and poliomyelitis. The overall safety profile of the two vaccines was acceptable.

Child↗
PubMedDate not supplied

Adult tetanus in Accra, why the high mortality? An audit of clinical management of tetanus.

BACKGROUND: Tetanus is a life threatening infection relatively uncommon in the developed countries but occurs frequently in developing countries with case fatality rates of 40-60 %. Recent review of adult tetanus at the Korle-bu Teaching Hospital showed a high case fatality of 50%. In order to determine the factors underlying this high case fatality we conducted a retrospective clinical audit of the clinical management of adult tetanus admitted in 1994 to 2001 to the Korle-bu Teaching Hospital. METHODS: Data extracted from the admission and discharge books of the Fevers' Unit of Korle-bu Teaching Hospital, Accra and patient case notes were examined and analysed. RESULTS: Case fatality rate (CFR) varied from 25 % in 1999 to 72.7% in 2001. There was no gender difference in the case fatality. There was no significant difference in the mean age of those who died and those who survived, however, the CFR rose with age. The presence of neck and a dirty wound were associated with increased CFR. The CFR correlated with the severity of tetanus and increased when an expected treatment action, wound debridement, administration of antibiotics and/or immunoglobulin, was not performed. The administration of anti-tetanus toxin was associated with an increased CFR. CONCLUSION: The high case fatality rate in Accra was due to inappropriate management with most of the patients not treated with immunoglobulin and antibiotics and had inadequate wound care.

Adolescent↗
PubMed1984

Fragment C of tetanus toxin antagonizes the neuromuscular blocking properties of native tetanus toxin.

Tetanus toxin, fragment B and fragment C were assayed for toxicity on the mouse phrenic nerve-hemidiaphragm preparation. The native toxin was a potent blocker of neuromuscular transmission; fragment B possessed little toxicity and fragment C was atoxic. Pretreatment of tissues with fragment C antagonized the neuromuscular blocking properties of tetanus toxin, but not those of type A botulinum toxin or beta-bungarotoxin. Agents that antagonize cholera toxin (B subunit) and diphtheria toxin (CRM197) did not antagonize tetanus toxin and did not alter the ability of fragment C to antagonize tetanus toxin. Fragment C exerted its effect by competing with unbound toxin for receptor sites on the nerve membrane. The fragment did not: 1) displace bound toxin; 2) inhibit internalization of toxin; or 3) inhibit intracellular expression of toxicity. In assays on intact cells, under conditions in which toxin binding was not dissociable, fragment C binding to phrenic nerves had an apparent KD of approximately 1.4 X 10(-7) M. Homogenates of mouse cerebral cortex adsorbed tetanus toxin and these homogenates competed with phrenic nerves for unbound toxin. Homogenized cortex did not displace or promote desorption of toxin already bound to phrenic nerves. Homogenates of eel and torpedo electric organ were not very effective in adsorbing toxin.

Adsorption↗
PubMed2003

Immune response to a diphtheria and tetanus toxoid administration in a three-dose diphtheria tetanus whole-cell pertussis/enhanced inactivated poliovirus vaccination schedule: a 7-year follow up.

The immune response to diphtheria and tetanus toxoid components of a combined diphtheria tetanus whole-cell pertussis/enhanced inactivated poliovirus (DTwP/eIPV) vaccine, administered in a three-dose schedule to infants at 2, 3 1/2 and 10 months of age and followed by a booster at the age of 8 years, was compared with the immune profile of a group of children at the same ages given the customary DTwP vaccine schedule at 2, 4, 6, and 12 months of age and a booster at the age of 8. Diphtheria- and tetanus-antitoxin titers were measured in parallel enzyme-linked immunosorbent assay (ELISA) and radioimmunoassay (RIA). After the reinforcing dose given at 10 months of age, diphtheria antitoxin concentrations of > or = 0.01 IU/ml were found in 100% of infants in the study group, 91.7% of whom reached a titer of > or = 0.1 IU/ml and a geometric mean titer (GMT) of 0.40 and 0.93 IU/ml in ELISA and RIA, respectively. At 3 and 6 years of age, diphtheria antitoxin values of > or = 0.01 IU/ml were detected in 100 and 94% of children with GMT of 0.043 and 0.024 IU/ml, respectively. Seropositivity and GMT values indicative of protection were measured by both ELISA and RIA after the booster at the age of 8 years. Similar results were found in the control group, although the GMT tended to be higher. A good correlation between results obtained by ELISA vs. RIA was evident throughout. Priming at 2 and 3 1/2 months with diphtheria and tetanus antitoxin, as a component of a DTwP program, and reinforcing 6 months later induced an immune response indicative of protection against the diseases, which persisted up to the age of the booster recommended at school entry.

Child↗
PubMed1975

Active immunization against tetanus in man. III. Antibody response to vaccine injections in the presence of therapeutic doses of human tetanus immune globulin. a record of five cases.

The tetanus antitoxin titres of five tetanus cases treated with 6,000-45,000 IU of human immune globulin and 2-4 doses of adsorbed tetanus toxoid were followed during 1 year. A typical response to the second injection of toxoid might be masked by the passively administered antibodies. The rise in titre after the third injection of toxoid was of the same magnitude as in patients receiving only active immunization. Hence the possible impediment by large doses of human immune globulin does not seem to play any practical role in complete immunization with three doses of tetanus toxoid.

Adolescent↗
PubMed1976

[Changes in anti-tetanus antibodies under sero-toxoid therapy. Study in 50 patients with tetanus].

A study concerning changes in anti-tetanus antibody (ATA) levels in 50 patients with tetanus following the injection of antitetanic serum of equine origin and of toxoid, the first dose of the latter being given 24 hours after the administration of serum and the others at intervals of 5 to 7, 15 and 30 days. Repeated estimation of ATA demonstrated, regardless of the toxoid dose protocol adopted, that levels did not reach 0.1 IU/ml on the 30th day and that they only rose late. By contrast, after a booster, the increase was the same as that seen in subjects who had not acquired tetanus. The various factors which may underly defective active immunisation during the acute phase of tetanus are discussed. Heterologue serum therapy, which has been held responsible, cannot be considered to be a responsible factor since patients who did not receive serum behaved in exactly the same way as those who had. By virtue of this "gap" in the acquisition of immunity, the use of heterologue serum is recommended to neutralise any remaining circulating toxin as rapidly as possible.

Age Factors↗