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Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis

2014-08-27 03:12:31 | BioPortfolio

Summary

This is a phase I, open-label, single arm trial, which aims to assess the safety of the vaccine prepared sm14 in healthy subjects. The product immunogenicity will be evaluated by conducting serology (anti-sm14 antibodies) and testing of cellular response to the antigen by the method ELI-SPOT. Each participant will remain in the study for approximately 4 months. The total study duration is 10 months, considering a period of 6 months for inclusion. Will be included in the study subjects male and female, between 18 and 49 years, that manifest their will to participate in the research by signing an Informed Consent Form. Eligible population for the study are subjects who do not present at screening significant changes in renal, cardiac and liver functions, complete blood count, clotting, present no acute or chronic illnesses, are not in the chronic use of any medication, do not have HIV infection or other immunodeficiency. Pregnant or breastfeeding women will not be included. Volunteers will receive three doses of vaccine prepared sm14, in doses containing 50 mcg of the antigen, associated with adjuvant GLA-SE at a dose of 10 mcg, with an interval of 30 days between each application. Twenty volunteers will be included in the study. This is a convenience sample, established for the first test of the product in humans, for the initial safety assessment.

Study Design

Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Schistosomiasis

Intervention

sm14 antigen plus adjuvant GLA

Location

Instituto de Pesquisa Clínica Evandro Chagas (IPEC) - Fiocruz
Rio de Janeiro
Brazil
21040900

Status

Not yet recruiting

Source

Oswaldo Cruz Foundation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:31-0400

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