Phase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazil

Detalhes bibliográficos
Autor(a) principal: Marzochi, Keyla B. F.
Data de Publicação: 1998
Outros Autores: Marzochi, Mauro C A, Silva, Aline F., Grativol, Neiva, Duarte, Rosemere, Confort, Eliame Mouta, Modabber, Farrokh
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/43926
Resumo: Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Hospital Evandro Chagas. Rio de Janeiro, RJ, Brasil.
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spelling Marzochi, Keyla B. F.Marzochi, Mauro C ASilva, Aline F.Grativol, NeivaDuarte, RosemereConfort, Eliame MoutaModabber, Farrokh2020-10-11T20:49:00Z2020-10-11T20:49:00Z1998MARZOCHI, Keyla B. F. et al. Phase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazil. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 93, n. 2, p. 205-212, Mar./Apr. 1998.0074-0276https://www.arca.fiocruz.br/handle/icict/4392610.1590/S0074-027619980002000141678-8060engFundação Oswaldo Cruz. Instituto Oswaldo Cruz.LeishmanioseVacinaEstudo de fase IEfeitos colateraisTeste cutâneo de MontenegroLeishmaniaVaccinePhase I studySide effectsMontenegro skin testPhase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazilinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Instituto Oswaldo Cruz. Hospital Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Departamento de Ciências Biológicas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Departamento de Ciências Biológicas. Rio de Janeiro, RJ, Brasil.Sem afiliaçãoFundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Departamento de Ciências Biológicas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Departamento de Ciências Biológicas. Rio de Janeiro, RJ, Brasil.WHO/TDRHQ. Geneva.A Phase 1 double-blind placebo-controlled study was performed to evaluate a vaccine against American tegumentary leishmaniasis in 61 healthy male volunteers. Side effects and the immune response to the vaccine were evaluated, with 1- and 2- dose schemes, with intervals of 7 or 21 days, each dose containing 1440 mg of protein N antigen of a single strain of Leishmania amazonensis (PH 8) diluted in merthiolated saline (1:10,000). Merthiolated saline and an inert substance were used as placebos. No significant clinical alterations were found following the respective injections in the vaccinated individuals as compared to the placebos, except for local pain, which was associated significantly with injection of the vaccine. The laboratory alterations we observed bore no association with the clinical findings and were unimportant. We observed no differences between the groups with regard to seroconversion or the Montenegro skin test. However, the group that received a single dose of the vaccine and the one that received two doses with a 21-day interval displayed cutaneous induration significantly larger than in the control group, with 100%, 100%, and 66% conversion in the skin test, respectively. We concluded that the vaccine does not present any major side effect that would contraindicate its use in healthy individuals.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/43926/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALKeila_Marzochi_etal_IOC_1998.pdfKeila_Marzochi_etal_IOC_1998.pdfapplication/pdf98227https://www.arca.fiocruz.br/bitstream/icict/43926/2/Keila_Marzochi_etal_IOC_1998.pdf535da9b1b6f684a74734afe289a68dd9MD52TEXTKeila_Marzochi_etal_IOC_1998.pdf.txtKeila_Marzochi_etal_IOC_1998.pdf.txtExtracted texttext/plain34455https://www.arca.fiocruz.br/bitstream/icict/43926/3/Keila_Marzochi_etal_IOC_1998.pdf.txt641dfa0efc1522bf981cd961d947d400MD53icict/439262020-10-12 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dc.title.pt_BR.fl_str_mv Phase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazil
title Phase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazil
spellingShingle Phase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazil
Marzochi, Keyla B. F.
Leishmaniose
Vacina
Estudo de fase I
Efeitos colaterais
Teste cutâneo de Montenegro
Leishmania
Vaccine
Phase I study
Side effects
Montenegro skin test
title_short Phase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazil
title_full Phase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazil
title_fullStr Phase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazil
title_full_unstemmed Phase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazil
title_sort Phase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazil
author Marzochi, Keyla B. F.
author_facet Marzochi, Keyla B. F.
Marzochi, Mauro C A
Silva, Aline F.
Grativol, Neiva
Duarte, Rosemere
Confort, Eliame Mouta
Modabber, Farrokh
author_role author
author2 Marzochi, Mauro C A
Silva, Aline F.
Grativol, Neiva
Duarte, Rosemere
Confort, Eliame Mouta
Modabber, Farrokh
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Marzochi, Keyla B. F.
Marzochi, Mauro C A
Silva, Aline F.
Grativol, Neiva
Duarte, Rosemere
Confort, Eliame Mouta
Modabber, Farrokh
dc.subject.other.pt_BR.fl_str_mv Leishmaniose
Vacina
Estudo de fase I
Efeitos colaterais
Teste cutâneo de Montenegro
topic Leishmaniose
Vacina
Estudo de fase I
Efeitos colaterais
Teste cutâneo de Montenegro
Leishmania
Vaccine
Phase I study
Side effects
Montenegro skin test
dc.subject.en.pt_BR.fl_str_mv Leishmania
Vaccine
Phase I study
Side effects
Montenegro skin test
description Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Hospital Evandro Chagas. Rio de Janeiro, RJ, Brasil.
publishDate 1998
dc.date.issued.fl_str_mv 1998
dc.date.accessioned.fl_str_mv 2020-10-11T20:49:00Z
dc.date.available.fl_str_mv 2020-10-11T20:49:00Z
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 MARZOCHI, Keyla B. F. et al. Phase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazil. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 93, n. 2, p. 205-212, Mar./Apr. 1998.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/43926
dc.identifier.issn.pt_BR.fl_str_mv 0074-0276
dc.identifier.doi.none.fl_str_mv 10.1590/S0074-02761998000200014
dc.identifier.eissn.none.fl_str_mv 1678-8060
identifier_str_mv MARZOCHI, Keyla B. F. et al. Phase 1 Study of an Inactivated Vaccine against American Tegumentary Leishmaniasis in Normal Volunteers in Brazil. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 93, n. 2, p. 205-212, Mar./Apr. 1998.
0074-0276
10.1590/S0074-02761998000200014
1678-8060
url https://www.arca.fiocruz.br/handle/icict/43926
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Fundação Oswaldo Cruz. Instituto Oswaldo Cruz.
publisher.none.fl_str_mv Fundação Oswaldo Cruz. Instituto Oswaldo Cruz.
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
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