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Sustainable Development Goals
03 Saúde e Bem-EstarCollections
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DEVELOPMENT OF THE SM14/GLA-SE SCHISTOSOMIASIS VACCINE CANDIDATE: AN OPEN, NON-PLACEBO-CONTROLLED, STANDARDIZED- DOSE IMMUNIZATION PHASE IB CLINICAL TRIAL TARGETING HEALTHY YOUNG WOMEN
Esquistossomose
Ensaio clínico de Fase Ib
Toxicologia
Coelhas grávidas
Proteína Sm14
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Affilliation
Abstract
We report the successful closure of Phase I clinical trials, comprising Phases Ia and Ib, of the
vaccine candidate against human schistosomiasis: the Schistosoma mansoni 14 kDa fatty acid-binding
protein (Sm14) + glucopyranosyl lipid A in squalene emulsion (GLA-SE). Shown here are the results of
Phase Ib, an open, non-placebo-controlled, standardized-dose immunization trial involving 10 healthy
18–49-year-old women. Fifty micrograms of the Sm14 protein plus 10 g GLA-SE per dose was given
intramuscularly thrice at 30-day intervals. Participants were assessed clinically, biochemically, and
immunologically for up to 120 days. In preambular experiments involving vaccinated pregnant
female rabbits, we did not find any toxicological features in either the offspring or mothers, and the
vaccine induced adaptive immunity in the animals. In women, no adverse events were observed,
and vaccination induced high titers of anti-Sm14 serum IgG antibody production. Vaccination also
elicited robust cytokine responses, with increased TNF , IFN
, and IL-2 profiles in all vaccinees
on days 90 and 120. The completion of Phase I clinical trials, which were performed to the highest
standards set by Good Clinical Research Practice (GCP) standards, and preclinical data in pregnant
rabbits enabled the vaccine candidate to proceed to Phase II clinical trials in endemic areas.
Keywords in Portuguese
VacinaEsquistossomose
Ensaio clínico de Fase Ib
Toxicologia
Coelhas grávidas
Proteína Sm14
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