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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
Healthy adults will receive 3 doses of the vaccine, on days 0, 30 and 60.
Instituto de Pesquisa Clínica Evandro Chagas (IPEC) - Fiocruz
Rio de Janeiro, Rio de Janeiro, Brazil
Safety of the vaccine
Safety and tolerability of the vaccine (sm14 antigen plus GLA adjuvant) against schistosomiasis in health adults
Time frame: 4 months after the first dose
Proportion of seroconversion
Proportion of seroconversion for sm14 antigen 30 days after the complete vaccinal schedule (3 doses, 30 days apart)
Time frame: 30 days after the third vaccine dose
Cellular immune response to sm-14 vaccination in health adults
Determine the cellular immune responses and their correlation to the development and magnitude of humoral responses
Time frame: 30 days after the third vaccine dose
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