Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil

Detalhes bibliográficos
Autor(a) principal: Linhares, Alexandre da Costa
Data de Publicação: 1996
Outros Autores: Gabbay, Yvone Benchimol, Mascarenhas, Joana D'Arc Pereira, Freitas, Ronaldo Barros de, Oliveira, C. S, Bellesi, Newton, Monteiro, Talita Antônia Furtado, Lins-Lainson, Zéa Constante, Ramos, Francisco Lúzio de Paula, Valente, Sebastião Aldo da Silva
Tipo de documento: Artigo
Idioma: por
Título da fonte: Repositório Digital do Instituto Evandro Chagas (Patuá)
Texto Completo: http://patua.iec.gov.br//handle/iec/3218
Resumo: 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 3-5 in 2-3 per cent 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 per cent of vaccinees and 33 per cent of placebo recipients. Neutralizing antibody responses to individual serotypes did not exceed 20 per cent when measured by fluorescent focus reduction, but exceeded 40 per cent 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 per cent (P = 0.005) against any diarrhoea and 35 per cent (P = 0.03) against any rotavirus diarrhoea. Protection during the first year of follow-up, when G serotype 1 rotavirus predominated, was 57 per cent (P = 0.008), but fell to 12 per cent 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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spelling Linhares, Alexandre da CostaGabbay, Yvone BenchimolMascarenhas, Joana D'Arc PereiraFreitas, Ronaldo Barros deOliveira, C. SBellesi, NewtonMonteiro, Talita Antônia FurtadoLins-Lainson, Zéa ConstanteRamos, Francisco Lúzio de PaulaValente, Sebastião Aldo da Silva2018-07-12T18:22:52Z2018-07-12T18:22:52Z1996LINHARES, Alexandre da Costa et al. Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil. Bulletin of The World Health Organization, v. 74, n. 5, p. 491-500, 1996.http://patua.iec.gov.br//handle/iec/3218A 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 3-5 in 2-3 per cent 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 per cent of vaccinees and 33 per cent of placebo recipients. Neutralizing antibody responses to individual serotypes did not exceed 20 per cent when measured by fluorescent focus reduction, but exceeded 40 per cent 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 per cent (P = 0.005) against any diarrhoea and 35 per cent (P = 0.03) against any rotavirus diarrhoea. Protection during the first year of follow-up, when G serotype 1 rotavirus predominated, was 57 per cent (P = 0.008), but fell to 12 per cent 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.This study was supported by the WHO Division of Diarrhoeal and Acute Aespiratory Disease Control.Ministério da Saúde. Fundação Nacional de Saúde. Instituto Evandro Chagas. Belém, PA, Brasil..Ministério da Saúde. Fundação Nacional de Saúde. Instituto Evandro Chagas. Belém, PA, Brasil..Ministério da Saúde. Fundação Nacional de Saúde. Instituto Evandro Chagas. Belém, PA, Brasil.Ministério da Saúde. Fundação Nacional de Saúde. Instituto Evandro Chagas. Belém, PA, Brasil..Ministério da Saúde. Fundação Nacional de Saúde. Instituto Evandro Chagas. Belém, PA, Brasil.Clinica de Medicina Preventiva do Pará. Belém, PA, Brazil.Ministério da Saúde. Fundação Nacional de Saúde. Instituto Evandro Chagas. Belém, PA, Brasil..Ministério da Saúde. Fundação Nacional de Saúde. Instituto Evandro Chagas. Belém, PA, Brasil.Ministério da Saúde. Fundação Nacional de Saúde. Instituto Evandro Chagas. Belém, PA, Brasil.Ministério da Saúde. Fundação Nacional de Saúde. Instituto Evandro Chagas. Belém, PA, Brasil.porImmunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazilinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleVacinas contra Rotavirus / uso terapêuticoVacinas contra Rotavirus / análiseVacinas contra Rotavirus / imunologiainfo:eu-repo/semantics/openAccessreponame:Repositório Digital do Instituto Evandro Chagas (Patuá)instname:Instituto Evandro Chagas (IEC)instacron:IECORIGINALImmunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil.pdfImmunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil.pdfapplication/pdf1050535https://patua.iec.gov.br/bitstreams/0fbf187b-d9be-4653-bb62-07925562d135/downloade679f1c8665c0ed1e9b8f816614f1b9fMD51LICENSElicense.txtlicense.txttext/plain; charset=utf-871https://patua.iec.gov.br/bitstreams/4e46d0e3-73de-44eb-9db1-73b9f8a89dde/download52f1732ea66fbd1123abe39f5373b797MD52TEXTImmunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil.pdf.txtImmunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil.pdf.txtExtracted texttext/plain46326https://patua.iec.gov.br/bitstreams/543ff721-d013-46a5-9429-1ef825318d38/download6d83076d74d81206a9f2ea3cf82b4f0eMD55THUMBNAILImmunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil.pdf.jpgImmunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil.pdf.jpgGenerated Thumbnailimage/jpeg5431https://patua.iec.gov.br/bitstreams/3aec23fd-9481-475b-b436-889c8dc75496/downloadf4767b955f6c5f6b5e91ca3ac4816237MD56iec/32182022-10-20 21:05:57.536oai:patua.iec.gov.br:iec/3218https://patua.iec.gov.brRepositório InstitucionalPUBhttps://patua.iec.gov.br/oai/requestclariceneta@iec.gov.br || Biblioteca@iec.gov.bropendoar:2022-10-20T21:05:57Repositório Digital do Instituto Evandro Chagas (Patuá) - Instituto Evandro Chagas (IEC)falseVG9kb3Mgb3MgZG9jdW1lbnRvcyBkZXNzYSBjb2xlw6fDo28gc2VndWVtIGEgTGljZW7Dp2EgQ3JlYXRpdmUgY29tbW9ucy4=
dc.title.pt_BR.fl_str_mv Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil
title Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil
spellingShingle Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil
Linhares, Alexandre da Costa
Vacinas contra Rotavirus / uso terapêutico
Vacinas contra Rotavirus / análise
Vacinas contra Rotavirus / imunologia
title_short Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil
title_full Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil
title_fullStr Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil
title_full_unstemmed Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil
title_sort Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil
author Linhares, Alexandre da Costa
author_facet Linhares, Alexandre da Costa
Gabbay, Yvone Benchimol
Mascarenhas, Joana D'Arc Pereira
Freitas, Ronaldo Barros de
Oliveira, C. S
Bellesi, Newton
Monteiro, Talita Antônia Furtado
Lins-Lainson, Zéa Constante
Ramos, Francisco Lúzio de Paula
Valente, Sebastião Aldo da Silva
author_role author
author2 Gabbay, Yvone Benchimol
Mascarenhas, Joana D'Arc Pereira
Freitas, Ronaldo Barros de
Oliveira, C. S
Bellesi, Newton
Monteiro, Talita Antônia Furtado
Lins-Lainson, Zéa Constante
Ramos, Francisco Lúzio de Paula
Valente, Sebastião Aldo da Silva
author2_role author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Linhares, Alexandre da Costa
Gabbay, Yvone Benchimol
Mascarenhas, Joana D'Arc Pereira
Freitas, Ronaldo Barros de
Oliveira, C. S
Bellesi, Newton
Monteiro, Talita Antônia Furtado
Lins-Lainson, Zéa Constante
Ramos, Francisco Lúzio de Paula
Valente, Sebastião Aldo da Silva
dc.subject.decsPrimary.pt_BR.fl_str_mv Vacinas contra Rotavirus / uso terapêutico
Vacinas contra Rotavirus / análise
Vacinas contra Rotavirus / imunologia
topic Vacinas contra Rotavirus / uso terapêutico
Vacinas contra Rotavirus / análise
Vacinas contra Rotavirus / imunologia
description 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 3-5 in 2-3 per cent 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 per cent of vaccinees and 33 per cent of placebo recipients. Neutralizing antibody responses to individual serotypes did not exceed 20 per cent when measured by fluorescent focus reduction, but exceeded 40 per cent 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 per cent (P = 0.005) against any diarrhoea and 35 per cent (P = 0.03) against any rotavirus diarrhoea. Protection during the first year of follow-up, when G serotype 1 rotavirus predominated, was 57 per cent (P = 0.008), but fell to 12 per cent 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.
publishDate 1996
dc.date.issued.fl_str_mv 1996
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dc.identifier.uri.fl_str_mv http://patua.iec.gov.br//handle/iec/3218
identifier_str_mv LINHARES, Alexandre da Costa et al. Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil. Bulletin of The World Health Organization, v. 74, n. 5, p. 491-500, 1996.
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