Clinical Trial: Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Oswaldo Cruz Foundation

Current Primary Outcome: Safety of the vaccine [ Time Frame: 4 months after the first dose ]

Safety and tolerability of the vaccine (sm14 antigen plus GLA adjuvant) against schistosomiasis in health adults


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of seroconversion [ Time Frame: 30 days after the third vaccine dose ]
    Proportion of seroconversion for sm14 antigen 30 days after the complete vaccinal schedule (3 doses, 30 days apart)
  • Cellular immune response to sm-14 vaccination in health adults [ Time Frame: 30 days after the third vaccine dose ]
    Determine the cellular immune responses and their correlation to the development and magnitude of humoral responses


Original Secondary Outcome: Same as current

Information By: Oswaldo Cruz Foundation

Dates:
Date Received: June 29, 2010
Date Started: March 2011
Date Completion:
Last Updated: August 9, 2016
Last Verified: August 2016