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      Avaliação da proteção conferida pela vacina antimeningocócica BC no Estado de Santa Catarina, Brazil, 1990/92 Translated title: Evaluation of the protective efficacy of an antimeningococcal vaccine for serogroups B and C Neisseria meningitidis infections in Brazil, 1990/92

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          Abstract

          São apresentados os resultados da avaliação da vacina antimeningocócica BC de procedência cubana realizada com dados da vigilância epidemiológica de meningites do Estado de Santa Catarina, Brasil, dos anos de 1990-92. A eficácia para os casos confirmados por exames bacteriológicos foi de 59% (IC de 95%: 23 a 78%) para os menores de 4 anos e de 78% (IC de 95%: 54 a 90%) para as crianças de 4 a 7 anos. Com os casos confirmados como causados por sorogrupo B, as eficácias estimadas foram maiores, mas se ampliaram os intervalos de confiança. O efeito protetor da vacina em relação à mortalidade em crianças menores de 4 anos foi estimado em 76% (IC 95%: 41 a 91%). Outros dados apresentados sugerem que as mais baixas eficácias encontradas, quando se analisam os menores de 4 anos, decorrem da seletividade da confirmação diagnóstica que exclui os casos mais graves que morrem a poucas horas do início dos sintomas, associada à modificação do curso da doença (atenuação) em vacinados. Por isso, indica-se a vacinação, inclusive em menores de 4 anos, nas situações epidêmicas.

          Translated abstract

          Results of the evaluation of the anti-meningococcal BC Cuban vaccine based on routine epidemiological surveillance information of meningitis for the years 1990 to 1992, following mass-vaccination of 232,022 children aged between 3 months and 7 years in 1989/90 during an epidemic of serogroup B meningococcal disease in the State of Santa Catarina, Brazil, are presented. The protective efficacy of the vaccine was calculated from the incidence rates for the cohort of vaccinated and non-vaccinated children in 20 municipalities. Main results for cases confirmed by bacteriological tests were 59% (CI 95%: 23 to 78%) for children aged under 4 years and 78% (CI 95%: 54 to 90%) for children aged 4 to 7 years. Eighty-six percent of cases serogrouped (n=29) were B, and in these cases efficacy increased to 66% (<4 years) and 88% (4-7 years), but at 95% CI were wider. The protective efficacy based on death rates from the disease in children <4 years was 76% (CI 95%: 41 to 91%). There was no evidence of decreasing protective efficacy in the three year follow-up, as shown by the yearly An interesting hypothesis arising from the findings is that the lower protective efficacy for children aged <4 years, observed in studies in which only cases confirmed by laboratory tests are analysed, could be due to a selective effect of this procedure. More severe cases die shortly after the onset of the disease, often before medical care is provided. On the other hand, the attenuation of the disease by vaccination gives a better chance for medical intervention and collection of samples for laboratory analysis. Finally, the authors support the use of the vaccine in epidemics of serogroup B meningococcal disease. estimates. They also suggest that three, rather than two doses of vaccine should be tested in children under 2 years of age to further increase its efficacy.

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          Estimation of a common effect parameter from sparse follow-up data.

          Breslow (1981, Biometrika 68, 73-84) has shown that the Mantel-Haenszel odds ratio is a consistent estimator of a common odds ratio in sparse stratifications. For cohort studies, however, estimation of a common risk ratio or risk difference can be of greater interest. Under a binomial sparse-data model, the Mantel-Haenszel risk ratio and risk difference estimators are consistent in sparse stratifications, while the maximum likelihood and weighted least squares estimators are biased. Under Poisson sparse-data models, the Mantel-Haenszel and maximum likelihood rate ratio estimators have equal asymptotic variances under the null hypothesis and are consistent, while the weighted least squares estimators are again biased; similarly, of the common rate difference estimators the weighted least squares estimators are biased, while the estimator employing "Mantel-Haenszel" weights is consistent in sparse data. Variance estimators that are consistent in both sparse data and large strata can be derived for all the Mantel-Haenszel estimators.
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            Vaccine against group B Neisseria meningitidis: protection trial and mass vaccination results in Cuba.

            The Cuban vaccine, first in the world with proven efficacy against group B-caused disease, is based on outer membrane proteins from B meningococci capable of inducing long-lasting and high-titered bactericidal antibodies in humans. This bactericidal activity has a wide spectrum against all pathogenic group B Neisseria meningitidis tested. A randomized, double-blind controlled trial of the vaccine efficacy was performed during 1987-1989 with 106,000 10-14 years old students from 197 boarding schools in seven provinces. The efficacy obtained was 83% (chi 2, p less than 0.002; Fischer exact, p less than 0.001). In a second field trial including 133,600 persons from 5 months to 24 years of age in Ciego de Avila province (30 cases/10(5) inhabitants, the highest incidence rate in Cuba) by comparing vaccinated and non-vaccinated population after 2.5 years of observation and careful follow-up, the efficacy and safety was confirmed. Because of these results and because of the very low reactogenicity of the vaccine, the Ministry of Public Health took the advice of the Scientific Council to vaccinate all children between 3 months and 6 years of age in the most affected provinces. No severe or long lasting reactions to the vaccine were observed after the millions of doses administered. The efficacy of vaccination varied in the provinces between 83% and 94%, among age groups ranging from 3 months and 20 years. After 3 years of massive application no severe reactions occurred and one of the most severe epidemics has been practically eradicated.
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              Protective efficacy of a serogroup B meningococcal vaccine in Sao Paulo, Brazil

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                Author and article information

                Journal
                rsp
                Revista de Saúde Pública
                Rev. Saúde Pública
                Faculdade de Saúde Pública da Universidade de São Paulo (São Paulo, SP, Brazil )
                0034-8910
                1518-8787
                October 1996
                : 30
                : 5
                : 460-470
                Affiliations
                [02] Florianópolis SC orgnameSecretaria de Saúde do Estado de Santa Catarina orgdiv1Serviço de Vigilância Epidemiológica Brasil
                [01] Rio de Janeiro RJ orgnameEscola Nacional de Saúde Pública orgdiv1Departamento de Epidemiologia e Métodos Quantitativos Brasil
                Article
                S0034-89101996000500009 S0034-8910(96)03000509
                10.1590/S0034-89101996000500009
                4e2a5aa4-a5f7-4b3d-9c79-f3788010d292

                This work is licensed under a Creative Commons Attribution 4.0 International License.

                History
                : 09 November 1995
                : 23 April 1996
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 10, Pages: 11
                Product

                SciELO Brazil

                Self URI: Texto completo somente em PDF (PT)
                Categories
                Artigos Originais

                Evaluation of public health interventions (process and outcome),Avaliação de ações de saúde pública ( processo e resultado),Bacterial vaccines,Vacinas bacterianas,Meningite meningocócica,Meningitis

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