Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil.

BACKGROUND: Because postlicensure surveillance determined that a previous rotavirus vaccine, RotaShield, caused intussusception in 1 of every 10,000 recipients, we assessed the association of the new monovalent rotavirus vaccine (RV1) with intussusception after routine immunization of infants in Mexico and Brazil. METHODS: We used case-series and case-control methods to assess the association between RV1 and intussusception. Infants with intussusception were identified through active surveillance at 69 hospitals (16 in Mexico and 53 in Brazil), and age-matched infants from the same neighborhood were enrolled as controls. Vaccination dates were verified by a review of vaccination cards or clinic records. RESULTS: We enrolled 615 case patients (285 in Mexico and 330 in Brazil) and 2050 controls. An increased risk of intussusception 1 to 7 days after the first dose of RV1 was identified among infants in Mexico with the use of both the case-series method (incidence ratio, 5.3; 95% confidence interval [CI], 3.0 to 9.3) and the case-control method (odds ratio, 5.8; 95% CI, 2.6 to 13.0). No significant risk was found after the first dose among infants in Brazil, but an increased risk, albeit smaller than that seen after the first dose in Mexico--an increase by a factor of 1.9 to 2.6 - was seen 1 to 7 days after the second dose. A combined annual excess of 96 cases of intussusception in Mexico (approximately 1 per 51,000 infants) and in Brazil (approximately 1 per 68,000 infants) and of 5 deaths due to intussusception was attributable to RV1. However, RV1 prevented approximately 80,000 hospitalizations and 1300 deaths from diarrhea each year in these two countries. CONCLUSIONS: RV1 was associated with a short-term risk of intussusception in approximately 1 of every 51,000 to 68,000 vaccinated infants. The absolute number of deaths and hospitalizations averted because of vaccination far exceeded the number of intussusception cases that may have been associated with vaccination. (Funded in part by the GAVI Alliance and the U.S. Department of Health and Human Services.).

Performance of rubella suspect case definition: implications for surveillance.

OBJECTIVE: To assess the performance of the rubella suspect case definition among patients with rash diseases seen at primary care units. METHODS: From January 1994 to December 2002, patients with acute rash, with or without fever, were seen at two large primary health care units and at a public general hospital in the municipality of Niterói, metropolitan area of Rio de Janeiro, Brazil. Data from clinical and serologic assessment were used to estimate the positive predictive values of the definition of rubella suspect case from the Brazilian Ministry of Health and other combination of signs/symptoms taking serologic status as the reference. Serum samples were tested for anti-rubella virus IgM using commercially available enzyme immunoassays. Positive predictive values and respective 95% confidence intervals were calculated. RESULTS: A total of 1,186 patients with an illness characterized by variable combinations of rash with fever, arthropathy and lymphadenopathy were studied. Patients with rash, regardless of other signs and symptoms, had 8.8% likelihood of being IgM-positive for rubella. The Brazilian suspect case definition (fever and lymphadenopathy in addition to rash) had low predictive value (13.5%). This case definition would correctly identify 42.3% of the IgM-positive cases, and misclassify 26.1% of the IgM-negative cases. CONCLUSIONS: These results support the recommendation to investigate and collect clinical specimens for laboratory diagnosis of all cases of rash, for surveillance purposes. Although this strategy may increase costs, the benefits of interrupting the circulation of rubella virus and preventing the occurrence of congenital rubella syndrome should pay off.

Performance of rubella suspect case definition: implications for surveillance

OBJETIVO: Avaliar a acurácia da definição de caso suspeito de rubéola entre pacientes com doenças exantemáticas atendidos em unidades de saúde pública.MÉTODOS: A população de estudo foi constituída de pacientes com doença exantemática, com ou sem febre, atendidos em serviços de saúde pública, de janeiro de 1994 a dezembro de 2002 no município de Niterói, RJ. Dados clínicos e sorológicos foram utilizados para estimar os valores preditivos positivos da definição de caso suspeito de rubéola do Ministério da Saúde do Brasil e outras combinações de sinais e sintomas, considerando o resultado da sorologia como referência. A detecção de IgM específica para rubéola em amostras sangüíneas foi realizada por ensaio imunoenzimático. Foram calculados os valores preditivos positivos e respectivos intervalos de confiança de 95 por cento. RESULTADOS: Foram estudados 1.186 pacientes com uma doença caracterizada por uma variada combinação de rash com ou sem febre, artropatia e linfoadenopatia. Pacientes com exantema, independentemente da presença de outros sinais e sintomas, apresentaram uma probabilidade de 8,8 por cento de serem IgM positivos para rubéola. A definição de caso suspeito de rubéola utilizada no Brasil apresentou baixo valor preditivo positivo (13,5 por cento). Esta definição de caso identificou corretamente 42,3 por cento dos casos IgM positivos, e classificou de forma incorreta 26,1 por cento dos IgM negativos. CONCLUSÕES: Os resultados indicam que as doenças exantemáticas devem ser investigadas em conjunto para fins de vigilância epidemiológica e coleta de espécimens clínicos para o diagnóstico laboratorial. Esta estratégia aumenta os custos, mas gera benefícios na interrupção da circulação do vírus e na prevenção da síndrome da rubéola congênita.