Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil
Autor(a) principal: | |
---|---|
Data de Publicação: | 1996 |
Outros Autores: | , , , , , , , , |
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. |
id |
IEC-2_6ff84f9e699a6dd85883508e9c8a9f1b |
---|---|
oai_identifier_str |
oai:patua.iec.gov.br:iec/3218 |
network_acronym_str |
IEC-2 |
network_name_str |
Repositório Digital do Instituto Evandro Chagas (Patuá) |
repository_id_str |
|
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 |
dc.date.accessioned.fl_str_mv |
2018-07-12T18:22:52Z |
dc.date.available.fl_str_mv |
2018-07-12T18:22:52Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.citation.fl_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. |
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. |
url |
http://patua.iec.gov.br//handle/iec/3218 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.source.none.fl_str_mv |
reponame:Repositório Digital do Instituto Evandro Chagas (Patuá) instname:Instituto Evandro Chagas (IEC) instacron:IEC |
instname_str |
Instituto Evandro Chagas (IEC) |
instacron_str |
IEC |
institution |
IEC |
reponame_str |
Repositório Digital do Instituto Evandro Chagas (Patuá) |
collection |
Repositório Digital do Instituto Evandro Chagas (Patuá) |
bitstream.url.fl_str_mv |
https://patua.iec.gov.br/bitstreams/0fbf187b-d9be-4653-bb62-07925562d135/download https://patua.iec.gov.br/bitstreams/4e46d0e3-73de-44eb-9db1-73b9f8a89dde/download https://patua.iec.gov.br/bitstreams/543ff721-d013-46a5-9429-1ef825318d38/download https://patua.iec.gov.br/bitstreams/3aec23fd-9481-475b-b436-889c8dc75496/download |
bitstream.checksum.fl_str_mv |
e679f1c8665c0ed1e9b8f816614f1b9f 52f1732ea66fbd1123abe39f5373b797 6d83076d74d81206a9f2ea3cf82b4f0e f4767b955f6c5f6b5e91ca3ac4816237 |
bitstream.checksumAlgorithm.fl_str_mv |
MD5 MD5 MD5 MD5 |
repository.name.fl_str_mv |
Repositório Digital do Instituto Evandro Chagas (Patuá) - Instituto Evandro Chagas (IEC) |
repository.mail.fl_str_mv |
clariceneta@iec.gov.br || Biblioteca@iec.gov.br |
_version_ |
1809190032960913408 |