NCT01154049

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

Phase 1 Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Oswaldo Cruz Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Schistosomiasis

Interventions

Type	Name	Description
BIOLOGICAL	sm14 antigen plus adjuvant GLA	Healthy adults will receive 3 doses of the vaccine, on days 0, 30 and 60.

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2010-06-30
• Last updated: 2016-08-10

Locations

1 site across 1 country: Brazil