Tétanos generalizado: Una amenaza persistente, reporte de tres casos y revisión de la literatura / Generalized tetanus: A persistent threat, review of the literature and report of three cases

RESUMEN INTRODUCCIÓN: El tétanos es una enfermedad inmunoprevenible, ocasionada por la bacteria Clostridium tetani, desencadenando una enfermedad caracterizada por espasmos musculares, insuficiencia respiratoria y disautonomías, potencialmente mortal. MATERIALES Y MÉTODOS: Presentamos una serie de tres pacientes que consultaron al servicio de urgencias por presentar trismus, rigidez muscular generalizada y dificultad respiratoria, requiriendo manejo en la unidad de cuidados intensivos, con relajación muscular y administración intramuscular e intratecal de inmunoglobulina antitetánica, con evolución satisfactoria en todos los casos. DISCUSIÓN: Su tratamiento está divido en dos grandes secciones; la primera parte, el control de la infección y eliminación del agente causal, con lavado y desbridamiento de heridas, administración de antibióticos y neutralización de la neurotoxina. La segunda parte del tratamiento está en el soporte vital en la unidad de cuidados intensivos, con la administración de sedación, relajación muscular, control de disautonomías y manejo de complicaciones. CONCLUSIONES: El tétanos a pesar de los avances en vacunación aún es una enfermedad presente, cuyo diagnóstico y tratamiento rápido y adecuado, permite sobrevivir a los pacientes, como en los casos aquí reportados.

ABSTRACT INTRODUCTION: Tetanus is an immuno-preventable disease, produced by the bacterium Clostridium tetani, that causes a disease characterized by muscle spasms, respiratory insufficiency and life-threatening dysautonomia. MATERIALS AND METHODS: We present a series of three patients who consulted for trismus, muscle stiffness and respiratory failure, which required intensive care management, muscle relaxation, intramuscular and intrathecal administration of tetanus immu-noglobulin, with satisfactory outcomes in all the cases. DISCUSSION: Its treatment is divided into two main sections; the first part, the control of infection and elimination of the causative agent, with washing and debridement of wounds, administration of antibiotics and neutralization of the neurotoxin. The second part is life support in the intensive care unit, with the administration of sedation, muscular relaxation and control of dysautonomia and the management of complications. CONCLUSIONS: Despite the advances in vaccination, tetanus is still a present disease, whose diagnosis and rapid and adequate treatment allows patients to survive, as in the cases reported here.

Niveles de antitoxina tetánica y diftérica relacionadas con el alelo HLA-B27 en pacientes cubanos con uveítis anterior no infecciosa / Tetanus and diphtheria antitoxin levels related to the HLA-B27 allele in Cuban patients with non-infectious anterior uveitis

La uveítis anterior no infecciosa es una enfermedad inflamatoria del ojo que afecta al tracto uveal y que puede causar ceguera total y otras discapacidades visuales. Esta enfermedad se ubica en el espectro de enfermedades autoinmunes y autoinflamatorias. Se han descrito respuestas no adecuadas a la vacunación en enfermedades mediadas por el sistema inmune, por lo que se evaluaron los niveles de antitoxina tetánica y diftérica en pacientes cubanos con uveítis anterior no infecciosa, relacionada con el alelo HLA-B27. Se determinaron los niveles de antitoxina tetánica y diftérica mediante ELISA en 190 pacientes con uveítis anterior no infecciosa y controles supuestamente sanos. El 97,37 por ciento de los pacientes con uveítis mostraron niveles de protección de antitoxina tetánica mayor o igual a 0,1 UI/mL, similar a lo observado en los controles sanos (98,95 por ciento) (p=0,4385). Las proporciones de pacientes con uveítis anterior no infecciosa y sus controles en los diferentes niveles de protección de antitoxina tetánica fueron similares (p>0,05), al igual que los títulos medios geométricos (p=0,2907). En los pacientes con uveítis, de 65 años o más, se detectó una mayor proporción de individuos con títulos protectores de larga duración (>1,0 UI/mL) de antitoxina diftérica (p=0,0065). En los pacientes con uveítis no se observó asociación entre la presencia del alelo HLA-B27 y la respuesta de anticuerpos frente al toxoide tetánico (p=0,6196) y diftérico (p=0,1917). El 37,9 por ciento de los pacientes con uveítis y el 42 por ciento de los controles, presentaron títulos no protectores (<0,1 UI/mL) de antitoxina diftérica (0,1148). La mayoría de los pacientes con uveítis anterior no infecciosa y los controles supuestamente sanos presentaron protección frente al toxoide tetánico; mientras que, en los pacientes con uveítis, así como en los controles supuestamente sanos, con edad igual o más de 18 años, se debe reevaluar incluir refuerzos con toxoide diftérico para alcanzar mayores niveles de protección frente a la difteria(AU)

Non-infectious anterior uveitis is an inflammatory disease of the eye that affects the uveal tract and can cause total blindness and other visual disabilities. Autoimmune and inflammatory diseases are associated with qualitative and quantitative alterations in the immune response; therefore, the levels of tetanus and diphtheria antitoxin related to the HLA-B27 allele were evaluated in Cuban patients with non-infectious anterior uveitis. Tetanus and diphtheria antitoxin levels were determined by ELISA in 190 patients with non-infectious anterior uveitis and healthy control individuals. 97.37 percent of patients with uveitis showed protective tetanus antitoxin levels greater than and equal to 0.1 IU/mL as well as healthy controls (98.95 percent) (p=0.4385). The proportions of patients with non-infectious anterior uveitis and presumably healthy controls in the different levels of protective tetanus antitoxin were similar (p>0.05) at all levels of protection, as were the geometric mean titers for this antitoxin (p=0.2907). Patients with uveitis aged 65 years or older had a higher proportion of individuals with long-term reliable protective titers (>1.0 IU/mL) of diphtheria antitoxin (p=0.0065). In uveitis patients, no association was observed between the presence of the HLA-B27 allele and the antibody response against tetanus toxoid (p=0.6196) and diphtheria (p=0.1917). Similarly, 37.9 percent of patients with uveitis and 42 percent of their controls had non-protective titers (<0.1 IU/mL) of diphtheria antitoxin (0.1148). Most patients with anterior uveitis and control subjects were protected against tetanus (p>0.05), while in patients with uveitis and supposedly healthy controls, aged 18 years or older, the administration of booster doses with diphtheria toxoid should be reevaluated to achieve higher levels of protection against diphtheria(AU)

[Anti-tetanus immunity among university students and health staff in North Lebanon and administration of anti-tetanus serums in two hospitals]

Tetanus is a serious illness that kills about one million people a year globally. This study aimed to i] evaluate immunity against tetanus [by antibodies titres in blood] among health staff and students at the Public Health Faculty, Lebanese University, ii] explore the determinants of the anti-tetanus immunity by a questionnaire and iii] estimate anti-tetanic serum use in the emergency departments of two hospitals [1 private, 1 public] in Tripoli. Most of the participants [76.6%] had anti-tetanus antibody titres >/= 0.1 UI/mL. There was no association between immune status and gender [P = 0.614] but more participants =/< 25 years were immunized than those > 25 years [P < 0.001] and more students were immunized than employees [P = 0.032]. There was an inverse association between anti-tetanus immunity and having visited a physician in the past year [P = 0.009]. In 2011, 1037 people received anti-tetanus immunoglobulins at the hospitals, 73% at the private hospital. Vaccination campaigns targetting adults > 25 years may be warranted to assure good anti-tetanus protection and avoid administration of anti-tetanus immunoglobulins in emergency departments

Tétanos generalizado: caso clínico y revisión del tema / Generalized tetanus: clinical case report and review of the literature

Tetanus is a severe and potentially mortal disease, which affects the Nervous System, caused by the bacteria Clostridium tetani. It's endemic in developing countries, presenting in Chile with a rate of 0,02 cases per 100.000 habitants, but the antitetanic vaccine has reduced its incidence in developed countries. We present here a case report of a patient with generalized tetanus from our hospital. The clinical presentation was characterized by generalized increased muscle tone and trismus, and the patient was hospitalized in the Intensive Care Unit. The neurologic manifestations were important for a period of 3 weeks, but then they started decreasing until the patient was discharged, without complications and being able to sit and walk with assistance. In relation to this case, we will review the actualizations in the subject of Tetanus. The recommended treatment includes support therapy, prevention of complications, antibiotics, muscle relaxants and anti-tetanospasmin immunoglobulin; all therapies that our patient received partially. The disease has a mortality that reaches the 50 percent in some series, but the ones who survive have a good prognosis and full recovery. This is why the presentation of this case is important, being an infrequent disease that must be diagnosed timely and be treated adequately.

Introducción: El tétanos es una enfermedad grave y potencialmente mortal, que afecta al sistema nervioso y causada por la bacteria Clostridium tetani. Es endémica en países en desarrollo, teniendo en Chile el año 2007 una tasa de 0,02 casos por cien mil habitantes. La vacuna con el toxoide antitetánico ha disminuido ostensiblemente su incidencia en países desarrollados. Caso clínico: Se presenta el caso clínico de un paciente de 18 años con tétanos generalizado ingresado a nuestro hospital. Clínicamente se manifestó con un aumento del tono muscular generalizado y trismo. Se hospitalizó en la Unidad de Cuidados Intensivos. Los síntomas y signos neurológicos tuvieron una máxima intensidad de aproximadamente cuatro semanas; posteriormente fueron disminuyendo sin presentar complicaciones severas. Al alta el enfermo lograba sentarse y caminar con ayuda. Discusión: A propósito de este caso se hace una revisión de la literatura y actualización de esta grave enfermedad. El tratamiento recomendado incluye terapia de soporte, prevención de complicaciones, antibioterapia, relajantes musculares e inmunoglobulina antitetánica; terapias que este paciente recibió. Si bien esta enfermedad tiene una letalidad promedio de un 50 por ciento, los pacientes que sobreviven tienen buen pronóstico y recuperación completa. Por ello, la presentación de este caso clínico es importante, sobre todo siendo una condición poco frecuente, que debe diagnosticarse con prontitud y, así, recibir el tratamiento adecuado.

Tetanus immunity in individuals aged 50 years or older in Kashan, Iran

Tetanus can be only prevented by vaccination because immunity against this disease is rarely acquired, even by natural infections. To maintain long-term protective immunity against tetanus, booster immunization is essential for adolescents and adults. Most hospitalized cases and virtually all deaths occur in people over 60 years of age. The purpose of this study was to investigate the degree of protective tetanus immunity among 50 years of age and older people in Kashan city, Iran. This cross-sectional study carried out on 180 randomly individuals aged 50 years or older who were visiting a central laboratory for health examinations in 2008. Participants' serum levels of tetanus antitoxin were measured by enzyme linked immunosorbent assay. A standard questionnaire was used to collect demographic data and information about risk factors. The prevalence of protective tetanus immunity in various age groups was described and sociodemographic factors that potentially influenced the degree of tetanus immunity were analyzed. Overall, 180 persons were included. Of these, 72 [40%] had never received a toxoid booster, while 47 [26.1%] had received a booster at least once. Among all participants, 30 [16.7%] had protective tetanus antitoxin levels [>/= 0.11 IU/mL], and 34 [18.9%] had protective antitoxin levels without the need of an immediate booster >/= 0.51 IU/mL. Among 86 participants aged>60 years, 6 [7%] had protective antitoxin levels >/= 0.1-1 IU/mL, and 5[5.8%] had protective antitoxin levels >/= 1 IU/mL. Male gender and prior receipt of toxoid booster[s] were associated with protective tetanus immunity. Tetanus antitoxin levels declined with age. It appears that most 50 years of age and older adults do not have protective levels of tetanus antitoxin because of inadequate vaccination coverage. There is a need to improve the immunity levels of this age group. It is recommended to vaccinate elderly people against tetanus

Proteção do recém-nascido contra o tétano pela imunização ativa da gestante com antitoxina tetânica: estudo original de 1953 / Protection of newborn infants against tetanus by active immunization of the pregnant women with tetanus antitoxin: the 1953 original study

OBJETIVO: Determinar, em cobaias prenhes e em gestantes, a produção de antitoxina tetânica induzida pela aplicação da anatoxina tetânica e estudar a sua passagem para o recém-nascido. MÉTODOS: Na primeira fase, em estudo experimental, cobaias prenhes foram vacinadas com duas doses de toxóide tetânico em um intervalo de 15 dias, seguida da dosagem de anticorpos na cobaia imunizada, na prole ao nascer e 15 dias após o nascimento. Outro grupo de animais previamente vacinado recebeu uma dose de reforço 30 dias antes do parto, medindo-se o nível de anticorpos na cobaia e na prole. Na segunda fase, em ensaio clínico, as gestantes humanas foram vacinadas com três injeções de anatoxina tetânica, com um intervalo de 30 dias, em qualquer período da gravidez, medindo-se, a seguir, a antitoxina tetânica. Nos recém-nascidos, os anticorpos foram medidos ao nascer e aos 15 dias de vida. RESULTADOS: O título de antitoxina no sangue da prole de cobaias vacinadas com anatoxina tetânica foi elevado ao nascimento e aos 15 dias de vida. A dose de reforço provocou elevação do título basal. Nas gestantes, a aplicação de três doses de toxóide antitetânico conferiu imunidade a 95% dos recém-nascidos estudados. Os recém-nascidos de mães vacinadas apresentaram títulos elevados de antitoxina que persistiram por mais de 15 dias de vida. CONCLUSÕES: A vacinação durante a gestação foi acompanhada de títulos protetores de antitoxina contra o tétano tanto nos filhotes de cobaias quanto nos recém-nascidos humanos.

OBJECTIVE: To measure, in pregnant guinea pigs and women, the production of tetanus antitoxin, induced by vaccination with tetanus toxin, and to study the transmission of these antibodies to the offspring. METHODS: In an experimental design, pregnant guinea pigs were vaccinated with two doses of tetanus toxoid with a 15-day interval followed by determination of antibodies in the immunized guinea pig, in the offspring at birth and after 15 days of life. One group of guinea pigs received a booster dose of tetanus toxoid 30 days before delivery and the immunization status of dam and offspring was also studied. In a clinical trial, pregnant women were vaccinated in any period of gestation with three doses of tetanus toxoid with a 30-day interval; the antibody levels were measured in the mother and in the newborn infant at birth and at the 15th day of life. RESULTS: The antibody levels of guinea pigs offspring immunized with tetanus toxoid during gestation were elevated at birth and at the 15th day of life. These levels were elevated by the booster dose 30 days prior to delivery. In pregnant women, the immunization with three doses of tetanus toxoid was followed by immunity in 95% of the studied infants studied. The newborn infants of vaccinated women presented elevated levels of antibodies at birth and at 15th day of life. CONCLUSIONS: Vaccination during gestation was followed by protective levels of antibodies in guinea pigs and in newborn infants.

Tétanos: Todavía un problema de salud pública / Tetanus: still a public health problem

El tétanos es una enfermedad inmunoprevenible que todavía causa estragos en las naciones que no han logrado coberturas protectoras de vacunación. Su tasa de letalidad alcanza el 50 por ciento. Es necesario que nuestro personal de salud esté familiarizado con su prevención, diagnóstico, tratamiento y rehabilitación. Esta revisión tiene como objetivo presentar una actualización de conocimientos sobre esta importante enfermedad, haciendo énfasis en el diagnóstico y el tratamiento.El tétanos es una enfermedad aguda de distribución mundial y presentación esporádica, infrecuente en países industrializados. Por su elevada tasa de letalidad aún representa un problema de salud pública, en especial en regiones con programas preventivos deficientes.

Tetanus is an immune-preventable disease which still causes ravages in nations without protective vaccination coverage. Its lethality rate is almost 50%. It is necessary that healthpersonnel are familiarized with its prevention, diagnosis, treatment and rehabilitation. Tetanus is an acute illness of worldwide distribution, sporadic occurrence and low frequency inindustrialized countries. Due to its high lethality rate it still is a public health problem, especially in regions with deficient preventive programs. This review presents up to date knowledge on different aspects of this important disease, with emphasis on its diagnosis and treatment.

Determination of low tetanus or diphtheria antitoxin titers in sera by a toxin neutralization assay and a modified toxin-binding inhibition test

A method for the screening of tetanus and diphtheria antibodies in serum using anatoxin (inactivated toxin) instead of toxin was developed as an alternative to the in vivo toxin neutralization assay based on the toxin-binding inhibition test (TOBI test). In this study, the serum titers (values between 1.0 and 19.5 IU) measured by a modified TOBI test (Modi-TOBI test) and toxin neutralization assays were correlated (P < 0.0001). Titers of tetanus or diphtheria antibodies were evaluated in serum samples from guinea pigs immunized with tetanus toxoid, diphtheria-tetanus or triple vaccine. For the Modi-TOBI test, after blocking the microtiter plates, standard tetanus or diphtheria antitoxin and different concentrations of guinea pig sera were incubated with the respective anatoxin. Twelve hours later, these samples were transferred to a plate previously coated with tetanus or diphtheria antitoxin to bind the remaining anatoxin. The anatoxin was then detected using a peroxidase-labeled tetanus or diphtheria antitoxin. Serum titers were calculated using a linear regression plot of the results for the corresponding standard antitoxin. For the toxin neutralization assay, L+/10/50 doses of either toxin combined with different concentrations of serum samples were inoculated into mice for anti-tetanus detection, or in guinea pigs for anti-diphtheria detection. Both assays were suitable for determining wide ranges of antitoxin levels. The linear regression plots showed high correlation coefficients for tetanus (r² = 0.95, P < 0.0001) and for diphtheria (r² = 0.93, P < 0.0001) between the in vitro and the in vivo assays. The standardized method is appropriate for evaluating titers of neutralizing antibodies, thus permitting the in vitro control of serum antitoxin levels.

Intrathecal tetanus immunoglobulins in the management of tetanus.

OBJECTIVE: To study the clinical profile, treatment and outcome of tetanus in children treated with intrathecal tetanus immunoglobulin. (TIG) METHODS: Retrospective analysis of hospital records of tetaus cases admitted to the pediatric ICU during the five year period between 1999 to 2004 was done. RESULTS: There were 66 cases of tetanus treated with intrathecal TIG. Children below 5 years formed 53% of cases and 47% were above 5 years. Totally unimmunized children constituted 82% of cases and 18% partially immunized children. The portal of entry was otogenic in 58% of cases and injury in30% of cases. The common complications observed included thrombophlebitis, aspiration pneumonia, laryngospasm and autonomic system involvement. There were no complications specific to intrathecal administration of TIG. The mortality due to tetanus was 9%. DISCUSSION: Mortality and morbidity due to tetanus was less in the present study compared to other centers where TIG is given intramuscularly. CONCLUSION: Intrathecal TIG is effective in the treatment of mild and moderate tetanus. Randomized controlled clinical trials are needed to evaluate the efficacy of intrathecal TIG in the management of severe tetanus.

Antitoxin response to tetanus toxoid [TT] versus combined tetanus -reduced diphtheria [TD] vaccination in pregnant women: clinical trial

Outbreaks of diphtheria in 1990s primarily involved adults. This reflects the decline of immunity with age. It is recommended to use the combined tetanus-diphtheria toxoid [Td] instead of the monovalent tetanus toxoid [TT] whenever tetanus toxoid is indicated. The protective efficacy following the new vaccinations schedule needs to be tested. The present study aimed to compare serum levels of diphtheria and tetanus antitoxin in pregnant women receiving [Td] vaccine and those receiving [TT] tetanus toxoid vaccine. As well as, to compare the frequency of adverse events following immunization between both groups. randomized, double blind controlled trial strategy was adopted. The reference population was pregnant women attending four rural health units in Abu Homos District, Egypt. A simple randomized procedure was used to allocate enrolled subjects [n = 130] to a study group [receiving Td vaccine] and a control group [receiving TT group] in a ratio of 1:1. The study revealed that before the vaccine administration, the mean values of tetanus antitoxin level in the experimental group [who received two doses of Td vaccine] and the control group [who received two doses of TT vaccine] did not differ significantly. After the first dose of vaccination, the mean tetanus antibody level was significantly lower in the Td group than in the TT group [t = 5.51, p < 0.001]. However, after the second dose, the mean tetanus antibody liter for Td group rise to 5.83 +/- 3.99 lU/ml and was still lower than that for the TT group [6.9 +/- 3.27 IU/ml] but this difference was not statistically significant, [t = 1.68, P = 0.096]. There were no significant differences between the two groups as regards the occurrence of systemic adverse events following either the first dose or second dose of Td or TT vaccine. On the other hand, the frequency of local adverse events following the first dose and second dose of Td vaccine were higher than that following TT vaccine. However, the difference was not statistically significant except for occurrence of local pain. The study concluded that tetanus-diphtheria toxoid [Td] can be used instead of single tetanus toxoid [TT] to protect against both tetanus and diphtheria. The local reactions associated with Td are usually self limited and require no therapy

Tetanus antitoxin levels and cutaneous anergy in hemodialysis patients in two University Hospitals in Iran

The global incidence of tetanus is about I million cases annually. Tetanus antibody values decrease with age. Some patients with humoral immune deficiencies may not respond adequately to tetanus toxoid vaccination. The incidence of infectious disease is increased in patients with chronic renal failure. The purpose of this study was to determine tetanus antitoxin level and cutaneous anergy test in hemodiaksis patients. A cross sectional study was performed on 44 hemodialysis patients who had been on dialysis thrice a week for at least 2 months. Quantitation of tetanus-specific antibodies was achieved by ELISA technique. Then, for Manteaux test 0.1 ml of 1/10 saline diluted solution of tetanus and diphtheria toxoid was injected intradermally to the volar surface of the shunt-free arm. Induration was recorded 48 - 72h and 7 - 9 days after the injection. Twenty-eight [64%] patients had induration /= 0.1 IU/ml. There was no significant correlation between age, sex, duration of dialysis, frequencies of dialysis history of tetanus-diphtheria vaccination, and tetanus antitoxin levels. There was a significant difference between induration size of anergy test results recorded on two separate observations [48 - 72h and 7 - 9 days after the test] [p < 0.05]. Our results indicate that immunization history was not consistent with protective antibody level, so monitoring immunization status and administering the tetanus vaccine in hemodialysis patients are required. Keywords: Anergy test, Anti-tetanus antibody, Hemodialysis

Apply the accelerated stability test to predict the self-life of national standard serum tetanus antitoxin

Accelerated stability test has been applied for predicting self-life of national standard serum tetanus anti-toxin (SAT). Samples of the tetanus antitoxin were kept at - 20°C, 4°C, 22°C, 37°C and 45°C for 6 months and their potency was estimated by using the toxin neutralization method on mice. There was relationship between the potency change and the self- life of serum tetanus antitoxin by using Arrhenius equation. The results demonstrated that the self-life of the national standard serum tetanus antitoxin was 9 years and 6 months when stored at -20°C.

Improvement of purification process of serum tetanus antitoxin

The diagram of immune system with antigene was the toxic extract from the repeating stage, making the rough serum up to the lowest of 150 Lf/ml (or 210IU/ml) and applied the method of taking horse’s blood and giving back red blood cells to increase the the rough serum two times. The new process did reduce the level fN-protein, time and increase the quantity and productivity of the purified serum. The purified serum was of high quality: clear color, low level of N-protein to 30% compared with registered standard (150mg/ml).

?mprovement of purification procedure of tetanus antitoxin

The decoloration of purified sera was achieved by using 0.1% caprylic acid solution with pH 4.2 at 56oC. The technique can shorten the duration of purification processes

Production of purified tetanus antitoxin for thrapeutic purpose

The Institute of Vaccine and Biologicals has recently released on market a purified tetanus antitoxin. The average potency of the product reached  3.000 IU/ml. The N-protein content is  70mg/ml

Recently Occurring Adult Tetanus in Korea: Emphasis on Immunization and Awareness of Tetanus

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.

Immunogenicity test of tetanus component in adsorbed vaccines by toxin binding inhibition test

Samples from 20 lots of diphtheria-tetanus (adult use dT) vaccine and from 20 lots of diphtheria-tetanus-pertussis (DTP) vaccine were used to standardize and validate the in vitro toxin binding inhibition (ToBI) test for the immunogenicity test of the tetanus component. The levels of tetanus antitoxin obtained by ToBI test were compared to those obtained using the toxin neutralization (TN) test in mice routinely employed to perform the quality control of the tetanus component in adsorbed vaccines. The results ranged from 1.8 to 3.5 IU/ml for dT and 2 to 4 IU/ml for DTP by ToBI test and 1.4 to 3 IU/ml for dT and 1.8 to 3.5 IU/ml for DTP by TN in mice. These results were significantly correlated. From this study, it is concluded that the ToBI test is an alternative to the in vivo neutralization procedure in the immunogenicity test of the tetanus component in adsorbed vaccines. A substantial refinement and a reduction in use of animals can be achieved

Chemical quality of purified tetanus antitoxin and anti-rabies serum produced at the Institute of Vaccine (IVAC), from 1997-2001

59 batches of purified tetanus antitoxin and 20 batches of anti-rabies serum (1997-2001) produced at IVAC Nha Trang were tested for: pH, total nitrogen, merthiolate content, sodium chloride content. In general, all the batches met the minimum requirements of the manufacture. However in order to improve the quality of the sera additional requirements should be set up