Ocorrência de eventos adversos após o uso da vacina adsorvida difteria, tétano e pertussis (acelular) - dTpa -, São Paulo, SP, 2015-2016 / Aparecimiento de eventos adversos después del uso de la vacuna adsorbida difteria, tétanos y tosferina (acelular) - dTpa -, São Paulo, SP, Brasil, 2015-2016 / Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine - Tdap -, São Paulo, SP, Brazil, 2015-2016

Objetivo: descrever a ocorrência de eventos adversos pós-vacinação (EAPV) com a vacina dTpa durante a gestação. Métodos: estudo descritivo, com dados de relatos das participantes de estudo de efetividade e imunogenicidade realizado em dois hospitais de São Paulo, SP, Brasil, entre 2015 e 2016. Resultados: das 201 mães incluídas no estudo, 48 (23,9%) apresentaram pelo menos um EAPV; foram identificados 60 sintomas relacionados ao uso da dTpa - dor (22,4%), inchaço (2,5%), febre (1,5%), sono (1,0%), vermelhidão (0,5%), vômito (0,5%), dor de cabeça (0,5%), reação local (0,5%) e cansaço (0,5%); não foram registrados eventos adversos raros, muito raros ou extremamente raros; todos os eventos foram considerados esperados e estão descritos em bula; todos tiveram desfecho para cura sem sequelas. Conclusão: a dTpa, na forma adotada pelo Programa Nacional de Imunizações (PNI), é segura; não foram identificados eventos adversos inesperados entre as gestantes imunizadas com a vacina.

Objetivo: describir el aparecimiento de eventos adversos posvacunación (EAPV) con la vacuna dTpa durante el embarazo. Métodos: estudio descriptivo con datos de relatos de las participantes del estudio de efectividad e inmunogenicidad realizado en dos hospitales de São Paulo, SP, Brasil, entre 2015 y 2106. Resultados: de las 201 madres del estudio, 48 (23,9%) tuvieron al menos un EAPV; se identificaron 60 síntomas relacionados al uso de dTpa - dolor (22.4%), hinchazón (2.5%), fiebre (1.5%), somnolencia (1.0%), enrojecimiento (0.5%), vómitos (0.5 %), dolor de cabeza (0.5%), reacción local (0.5%) y cansancio (0.5%) -; no se informaron eventos adversos raros, muy raros o extremadamente raros; todos los eventos se consideraron esperados y se describen en el prospecto; todos tuvieron resultados curativos sin secuelas. Conclusión: el estudio mostró que la vacuna dTpa utilizada por el Programa Nacional de Inmunización (PNI) es segura y no se identificaron eventos adversos inesperados entre las mujeres embarazadas vacunadas.

Objective: to describe occurrence of adverse events following immunization (AEFI) with Tdap vaccine during pregnancy. Methods: this was a descriptive study using data from reports by participants in an effectiveness and immunogenicity study conducted in two hospitals in São Paulo, SP, Brazil, from 2015 to 2016. Results: of the 201 mothers included in the study, 48 (23.9%) had at least one AEFI; 60 symptoms related to Tdap use were identified - pain (22.4%), swelling (2.5%), fever (1.5%), somnolence (1.0%), redness (0.5%), vomiting (0.5%), headache (0.5%), local reaction (0.5%), and fatigue (0.5%); no rare, very rare, or extremely rare adverse events were reported; all events were considered to be expected, as they are described in the vaccine package insert; outcome of all events was recovery without sequelae. Conclusion: Tdap vaccine in the form adopted by the National Immunization Program is safe; no unexpected adverse events were identified among vaccinated pregnant women.

Assessment of Serologic Immunity to Diphtheria-Tetanus-Pertussis After Treatment of Korean Pediatric Hematology and Oncology Patients

The aim of this study was to investigate the diphtheria-tetanus-pertussis antibody titers after antineoplastic treatment and to suggest an appropriate vaccination approach for pediatric hemato-oncologic patients. A total of 146 children with either malignancy in remission after cessation of therapy or bone marrow failure were recruited. All children had received routine immunization including diphtheria-tetanus-acellular pertussis vaccination before diagnosis of cancer. The serologic immunity to diphtheria, tetanus and pertussis was classified as: completely protective, partially protective, or non-protective. Non-protective serum antibody titer for diphtheria, tetanus and pertussis was detected in 6.2%, 11.6%, and 62.3% of patients, respectively, and partial protective serum antibody titer for diphtheria, tetanus and pertussis was seen in 37%, 28.1%, and 8.9% of patients. There was no significant correlation between the severity of immune defect and age, gender or underlying disease. Revaccination after antineoplastic therapy showed significantly higher levels of antibody for each vaccine antigen. Our data indicates that a large proportion of children lacked protective serum concentrations of antibodies against diphtheria, tetanus, and pertussis. This suggests that reimmunization of these patients is necessary after completion of antineoplastic treatment. Also, prospective studies should be undertaken with the aim of devising a common strategy of revaccination.

Diphtheria toxin IgG levels in military and civilian blood donors in Rio de Janeiro, Brazil

Serologic data on diseases that are preventable by vaccines are necessary to evaluate the success of immunization programs and to identify susceptible subgroups. In the present study, we determined serum IgG levels against diphtheria toxin of military and civilian blood donors (N = 75; 69.3 percent males and 30.7 percent females) aged 18-64 years, from the Brazilian Army Biology Institute, Rio de Janeiro, using a commercial diphtheria kit (Diphtheria IgG ELISA; IBL, Germany). Most (63 percent) unprotected military donors were from the older age group of 41 to 64 years. In contrast, the majority (71 percent) of young military donors (18 to 30 years) were fully protected. About half of the military donors aged 31 to 40 years were protected against diphtheria. Among the civilians, about 50 percent of persons aged 18 to 30 years and 31 to 40 years had protective antibody levels against diphtheria as also did 64 percent of individuals aged 41 to 64 years. All civilians had a similar antibody response (geometric mean = 0.55 IU/mL) independent of age group. Military donors aged 18-30 years had higher IgG levels (geometric mean = 0.82 IU/mL) than military donors of 41-64 years (geometric mean = 0.51 IU/mL; P > 0.05). In conclusion, the existence of a considerable proportion of susceptible adults supports the position that reliable data on the immune status of the population should be maintained routinely and emphasizes the importance of adequate immunization during adulthood.

A study on determinants of occurrence of complications and fatality among diphtheria cases admitted to ID & BG Hospital of Kolkata.

This was a hospital-based case series study of diphtheria patients admitted to ID & BG Hospital of Kolkata from May 2004 to April 2005. A total of 107 patients were included in the study. Report of follow up of admitted patients and interview of family members were done. The study results showed that the highest number of cases (31) were among the 6-10 year age group, while the lowest was among the 16-20 year age group (12). Overall case fatality was high (12.1%). Lowest case fatality (5%) among 21 years and above age group. Case fatality was less among those patients who were admitted to the hospital within 48 hours of occurrence of clinical features. Majority of the patients (72) developed complications. Among them, only Myocarditis occurred in 51, Myocarditis with Palatal palsy in 11, only Palatal palsy in 7, while Respiratory distress occurred in 3. Most of the admitted patients were non-immunized (84). Majority of the respondents (73) have no idea regarding the mode of spread of the disease. Only one respondent had correct knowledge about the benefit of the DPT vaccine. The main reason for non-immunization was ignorance (44%). IEC for full immunization coverage and early admission with proper management are indispensable for the reduction of diphtheria morbidity and mortality.

Prevalence of diphtheria and tetanus antibodies and circulation of Corynebacterium diphtheriae in São Paulo, Brazil

The introduction of routine vaccination against tetanus and diphtheria in Brazil has decreased the incidence and changed the epidemiology of both diseases. We then investigated the prevalence of Corynebacterium diphtheriae carrier status and diphtheria and tetanus immunity in São Paulo, Brazil. From November 2001 to March 2003, 374 individuals were tested for the presence of C. diphtheriae in the naso-oropharynx and of serum diphtheria and tetanus antibodies. Participants were all healthy individuals without acute or chronic pathologies and they were stratified by age as follows: 0-12 months and 1-4, 5-9, 10-14, 15-24, 25-39, 40-59, and ³60 years. Antibodies were assessed using a double-antigen ELISA. C. diphtheriae species were identified by biochemical analysis and toxigenicity was assessed by the Elek test. For diphtheria, full protection (antibodies ³0.1 IU/mL) was present in 84 percent of the individuals, 15 percent had basic protection (antibodies ³0.01 and <0.1 IU/mL) and 1 percent were susceptible (antibodies <0.01 IU/mL). Full tetanus protection (antibodies ³0.1 IU/mL) was present in 79 percent of the participants, 18 percent had basic protection (antibodies ³0.01 and <0.1 IU/mL) and 3 percent were susceptible (antibodies <0.01 IU/mL). The geometric mean of diphtheria and tetanus antibodies reached the highest values at 5-9 years and decreased until the 40-59-year age range, increasing again in individuals over 60 years. Three participants (0.8 percent) were carriers of C. diphtheriae, all non-toxigenic strains. The present results demonstrate the clear need of periodic booster for tetanus and diphtheria vaccine in adolescents and adults after primary immunization in childhood.

Tetanus and diphtheria immunity in adolescents from São Paulo, Brazil

Tetanus and diphtheria vaccines are of special concern in adolescents because boosters are necessary for adequate maintenance of protection and are often omitted. We assessed serum levels of tetanus and diphtheria antibodies in adolescents and their association with vaccination status. From May to October 2001, we evaluated the vaccination records of 208 adolescents aged 10 to 20 years in São Paulo, Brazil. Antibodies to tetanus and diphtheria were detected using double-antigen ELISA and vaccination records were analyzed according to the guidelines of the Brazilian National Immunization Program. All adolescents had received complete primary vaccinations against tetanus and diphtheria, but 23.1 percent of them had not received a booster dose in the last 10 years. All adolescents were immune to tetanus and 88.9 percent were fully protected (antibodies ³0.1 IU/mL). One individual (0.5 percent) was non-immune to diphtheria and 86 percent were fully protected against the disease. Adolescents with up-to-date vaccination records had higher antibody levels than those with not up-to-date records for tetanus (0.763 vs 0.239 IU/mL, t-test: P < 0.0001) and diphtheria (0.366 vs 0.233 IU/mL, t-test: P = 0.014). Full immunity against tetanus (antibodies ³0.1 IU/mL) was higher among individuals with up-to-date vaccination (93.1 percent) when compared to those with not up-to-date records (75 percent, Fisher's exact test: P = 0.001). All adolescents had received basic immunization in childhood and were protected against tetanus and diphtheria. However, these data indicate that more emphasis should be placed on the tetanus-diphtheria booster in order to avoid a decay in antibody levels.

Diphtheria-neutralizing antibody levels in healthy adults from Rio de Janeiro, Brazil

In Brazil, until 2004, the immunization policy against diphtheria involved childhood vaccination with no official routine booster dose administered after 15 years of age. This study assessed functional antibody levels against diphtheria among blood donors. A total of 140 blood samples were collected, and diphtheria antitoxin levels were evaluated by Vero cell neutralization test. The mean age of the population was 34 years old (range: 18-61 years); 37.8 percent females and 62.2 percent males. Overall, 30.7 percent (95 percent, CI: 23.4-38.7) individuals presented neutralizing antitoxin antibody titers < 0.01 IU/ml; 42.1 percent (95 percent, CI: 34.1-50.4) showed values between 0.01-0.09 IU/ml and, 27.1 percent (95 percent, CI: 20.2-34.9) had ³ 0.1 IU/ml. In the subgroup of individuals with history of diphtheria immunization during childhood (85 percent), a number of 28.5 percent showed unprotective levels of circulating neutralizing antibody (< 0.01 IU/ml). Despite the continuous progress of immunization programs directed to Brazilian population, currently healthy adults remain susceptible to diphtheria.

Effect of a single tetanus-diphtheria vaccine dose on the immunity of elderly people in São Paulo, Brazil

Epidemiological data regarding tetanus and diphtheria immunity in elderly people in Brazil are scarce. During the First National Immunization Campaign for the Elderly in Brazil in April 1999, 98 individuals (median age: 84 years) received one tetanus-dyphtheria (Td) vaccine dose (Butantan Institute, lot number 9808079/G). Inclusion criteria were elderly individuals without a history of severe immunosuppressive disease, acute infectious disease or use of immunomodulators. Blood samples were collected immediately before the vaccine and 30 days later. Serum was separated and stored at -20°C until analysis. Tetanus and diphtheria antibodies were measured by the double-antigen ELISA test. Tetanus and diphtheria antibody concentrations lower than 0.01 IU/mL were considered to indicate the absence of protection, between 0.01 and 0.09 IU/mL were considered to indicate basic immunity, and values of 0.1 IU/mL or higher were considered to indicate full protection. Before vaccination, 18 percent of the individuals were susceptible to diphtheria and 94 percent were susceptible to tetanus. After one Td dose, 78 percent became fully immune to diphtheria, 13 percent attained basic immunity, and 9 percent were still susceptible to the disease. In contrast, 79 percent remained susceptible to tetanus, 4 percent had basic immunity and 17 percent were fully immune. Although one Td dose increases immunity to diphtheria in many elderly people who live in Brazil, a complete vaccination series appears to be necessary for the prevention of tetanus.

Experience of combined tetravalent diphtheria, tetanus, whole-cell pertussis and hepatitis B vaccine in Thailand.

In 1992, hepatitis B (HB) vaccination of all newborns was officially included in the national expanded program on immunization (EPI), since satisfactory levels of immunity had been attained among the target populations of Chiang Mai and Chon Buri Province during the trial period, 1989 and 1992. In order to facilitate this process and to reduce the administrative costs created by integration of the additional vaccine, the option of combining HB vaccine with the DTP vaccine was investigated. Thus, in 1991 our group performed a clinical study of Smith Kline Beecham Biological's DTP-HB vaccine, administering it to 160 infants of HBsAg negative mothers at the age of 2, 4 and 6 months, respectively. We found the evoked immune responses to be at least equal to, if not higher, than those achieved with the monovalent vaccine. Likewise, any adverse reactions were comparable to those observed after administering either DTP or HB vaccine separately. According to our additional data, we consider HB vaccination at birth, followed by the combined DTP-HB vaccine at the ages of 2, 4, 6 and 18 months, respectively, most advantageous and we would recommend integrating this regimen into the basic immunization service. Thus, the possibility of eradicating hepatitis B infection altogether might eventually be provided.

Programa de inmunización para adultos / Program of immunization for adults

Mediante estudios epidemiológicos realizados por la Dirección General de Epidemiología SSA México, se ha detectado el resurgimiento de enfermedades virales o bacterianas en poblaciones fuera de la edad pediátrica, las cuales considerábamos superadas con la edad adulta, identificándose la necesidad de planterar un esquema de inmunizaciones para el adulto, desafortunadamente por nuestras propias limitantes no es posible llevar a cabo planteamientos más ambiciosos que obviamente originarían una cobertura más amplia en padecimientos susceptibles a prevención por medio de inmunización activa. La sugerencia de un programa básico de inmunización ofrece prevención a los siete padecimientos más frecuentes en nuestro medio (tétanos, difteria, sarampión, rubéola, parotiditis, neumonía neumocócica, hepatitis B), además presenta la ventaja de modificar o ampliar la aplicación de inmunógenos de acuerdo a las necesidades especifícas del individuo a tratar, la obtención de estos inmunógenos es posible ya sea por medio de las autoridades sanitarias o bien por su compra en laboratorios de productos médicos. En el presente trabajo se incluye: información general de cada padecimiento, datos epidemiológicos actualizados, indicaciones de inmunización, tipos de inmunógenos, vía de administración y dosis recomendadas, finalmente se propone en un esquema básico de inmunización para adultos y un formato que puede ser aplicado a la población en general con fines preventivos. Diseño del programa: basado en información bibliográfica y programas establecidos en las Instituciones de Salud. Estrategia: Inmunizaciones específicas a la población adulta en general con el fin de reactivar el programa vacunal efectuado en la etapa pediátrica

Immunity to diphtheria in women of childbearing age in Delhi in 1994: evidence of continued Corynebacterium diphtheriae circulation.

Blood samples from 171 full-term pregnant women (aged 18-38 years) of middle socioeconomic status from Delhi were tested for diphtheria antitoxins by indirect hemagglutination (IHA) test. History of primary immunization/clinical diphtheria during childhood was not ascertainable, but none had been revaccinated against diphtheria at any time. About 94% women had very high antitoxin titers (> or = 0.125 IU/ ml); none had antitoxin titer less than 0.015 IU/ml, the minimum protective level. The titers were uniformly high in all age groups. However, women having 2 or more children had significantly higher antitoxin titers than those having no or one child (p < 0.01). The results from this study and historical data on diphtheria in Delhi are compatible with continued transmission of C. diphtheriae in recent times in Delhi which is of sufficient magnitude to boost the antitoxin levels in adults, especially mothers having two or more children. The study highlights the need of increasing the immunization coverage with DPT among children to reduce the transmission of Corynebacterium diphtheriae.

Programa Nacional de imunizaçöes - 20 anos / Nacional Program of Immunizations - 20 years

O Programa Nacional de Imunizaçôes(PNI) foi formulado em 1973, pode determinaçäo do Ministro da Saúde, como parte de um conjunto de medidadas que se destinavam a redirecionar a atuaçäo governamental no setor. A proposta básica para o programa, constante de documento elaborado por técnicos do Departamento Nacional de Profilaxia e Controle de Doenças(Ministério da Saúde) e da Central de Medicamentos (CEME- Presidência da República), foi aprovada em reuniäo realizada em Brasília, no dia 18 de setembro de 1973, presidida pelo próprio Ministro e que contou com a participaçäo de renomados sanitaristas e infectologistas, bem como de representantes de diversas instituiçôes. A institucionalizaçäo do PNI foi resultante de um somatório de fatores, de âmbito nacional e internacional, que convergiam para estimular e expandir a utilizaçäo de agentes imunizantes no País

Immunity against diphtheria in the age group 15 to 25 years.

Levels of diphtheria antitoxin in 254 serum samples were estimated in subjects in the age group 15 to 25 years with no previous history of immunisation against diphtheria using indirect haemagglutination test. All the individuals showed more than 0.03 IU/ml of diphtheria antitoxin level. This indicates that the age group studied was not susceptible to diphtheria. No significant relationship could be, however, ascertained between diphtheria antitoxin level and epidemiological factors like age, area (rural/urban), socioeconomic status, family size, education status and religion.

Efectos secunarios de la vacuna contra la difteria, tétanos y tosferina / Secondary effects of the vaccine against diphteria, tetanus and whooping cough

Se investigaron las reacciones sistémicas y locales posteriores a la inmunización con vacuna contra la difteria, tétanos y tosferina (DPT). Se determinaron los efectos secundarios en 730 niños entre 2 meses y 5 años con 11 meses, en las 48 horas siguientes. Se encontró a 13% de niños libres de efectos adversos. El 87% inmunizados presentó efecto colateral, siendo la incidencia: fiebre, 66.03% ; malestar, 37.81%; disminución del apetito, 25.07%; transtornos del sueño, 20.41%; vómitos, 7.94% y llanto contínuo, 7.67%. En relación a efectos locales: dolor, 41.64%; enrojecimiento, 20.08% y nódulos subcutáneos, 20.14%. Ninguno de los niños presentó convulsiones, episodios hipotónicos o daño neurológico inmediato. Se colocaron dos tipos de vacuna DPT: la del Laboratorio Connaught (canadiense) y la del Instituto de Higiene (venezolana). No hubo direrencia significativa en la aparición de efectos secundarios entre ambas, excepto para el dolor logal (P<0.0s) con la vacuna nacional. Efectos obtenidos en relación con la edad y número de dosis: hubo aumento significativo de vómitos con la menor edad (P<0.01) así como incremento del dolor local a mayor edad (p<0.01). A pesar de las diversas controversias originadas por el uso de la vacuna DPT, consideramos que los beneficios derivados de la vacuna supran ampliamente los riesgos atribuibles a ella, por esto, apoyamos la recomendación de inmunizar rutinariamene a la población susceptible.