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Immunogenicidad, inocuidad y eficacia de una vacuna tetravalente obtenida por recombinación genética de rotavirus aislados de monos rhesus y seres humanos en Belém, Brasil

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1998
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Immunogenicidad, inocuidad y eficacia de una vacuna tetravalente obtenida por recombinación genética de rotavirus aislados de monos rhesus y seres humanos en Belém, Brasil.pdf (327.6xmlui.dri2xhtml.METS-1.0.size-kilobytes)
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http://patua.iec.gov.br//handle/iec/3224
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Linhares, Alexandre da Costa
Gabbay, Yvone Benchimol
Mascarenhas, Joana D'Arc Pereira
Freitas, Ronaldo Barros de
Oliveira, Consuelo Silva de
Bellesi, Newton
Monteiro, Talita Antônia Furtado
Lins-Lainson, Zéa Constante
Ramos, Francisco Lúzio de Paula
Valente, Sebastião Aldo da Silva
xmlui.dri2xhtml.METS-1.0.item-abstract
A tetravalent rhesus-human reassortant rotavirus (RRV-TV) vaccine (4 x 10(4) plaque-forming units/dose) was evaluated for safety, immunogenicity and efficacy in a prospective, randomized, double-blind, placebo-controlled trial involving 540 Brazilian infants. Doses of vaccine or placebo were given at ages, 1, 3 and 5 months. No significant differences were noted in the occurrence of diarrhoea or vomiting in vaccine and placebo recipients following each dose. Low-grade fever occurred on days 35 in 23% of vaccinees after the first dose, but not after the second or third doses of vaccine. An IgA antibody response to rhesus rotavirus (RRV) occurred in 58% of vaccinees and 33% of placebo recipients. Neutralizing antibody responses to individual serotypes did not exceed 20% when measured by fluorescent focus reduction, but exceeded 40% when assayed by plaque reduction neutralization. There were 91 cases of rotavirus diarrhoea among the 3-dose (vaccine or placebo) recipients during two years of follow-up, 36 of them among children given the vaccine. Overall vaccine efficacy was 8% (P = 0.005) against any diarrhoea and 35% (P = 0.03) against any rotavirus diarrhoea. Protection during the first year of follow-up, when G serotype 1 rotavirus predominated, was 57% (P = 0.008), but fell to 12% in the second year. Similar results were obtained when analysis was restricted to episodes in which rotavirus was the only identified pathogen. There was a tendency for enhanced protection by vaccine against illness associated with an average of 6 or more stools per day. These results are sufficiently encouraging to warrant further studies of this vaccine in developing countries using a higher dosage in an attempt to improve its immunogenicity and efficacy.
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LINHARES, Alexandre da Costa et al. Immunogenicidad, inocuidad y eficacia de una vacuna tetravalente obtenida por recombinación genética de rotavirus aislados de monos rhesus y seres humanos en Belém, Brasil Pan American Journal of Public Health, v. 3, n. 5, p. 326-336, 1998.
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Rotavirus / patogenicidade
Rotavirus / imunologia
Vacinas contra Rotavirus / administração & dosagem
Vacinas contra Rotavirus / imunologia
Vacinas / imunologia
Vacina contra Difteria, Tétano e Coqueluche / imunologia
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Instituto Evandro Chagas - SVS - MS - 2007-2018 Rodovia BR316 km 7 sn - Levilandia - 67030-000 - Ananindeua - Para - Brasil.
Licença Creative CommonsEste trabalho está licenciado com uma Licença Creative Commons - Atribuição-NãoComercial 4.0 Internacional
Tel: (55 91) 3214-2191
Email: biblioteca@iec.gov.br / clariceneta@iec.gov.br
 

 

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Instituto Evandro Chagas - SVS - MS - 2007-2018 Rodovia BR316 km 7 sn - Levilandia - 67030-000 - Ananindeua - Para - Brasil.
Licença Creative CommonsEste trabalho está licenciado com uma Licença Creative Commons - Atribuição-NãoComercial 4.0 Internacional
Tel: (55 91) 3214-2191
Email: biblioteca@iec.gov.br / clariceneta@iec.gov.br