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PHASE 1 STUDY OF AN INACTIVATED VACCINE AGAINST AMERICAN TEGUMENTARY LEISHMANIASIS IN NORMAL VOLUNTEERS IN BRAZIL
Vacina
Estudo de fase I
Efeitos colaterais
Teste cutâneo de Montenegro
Author
Affilliation
Fundação 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 afiliação
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.
WHO/TDRHQ. Geneva.
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 afiliação
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.
WHO/TDRHQ. Geneva.
Abstract
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.
Keywords in Portuguese
LeishmanioseVacina
Estudo de fase I
Efeitos colaterais
Teste cutâneo de Montenegro
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