Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis
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:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase 1 Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis|
- Safety of the vaccine [ Time Frame: 4 months after the first dose ] [ Designated as safety issue: Yes ]Safety and tolerability of the vaccine (sm14 antigen plus GLA adjuvant) against schistosomiasis in health adults
- Proportion of seroconversion [ Time Frame: 30 days after the third vaccine dose ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Determine the cellular immune responses and their correlation to the development and magnitude of humoral responses
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: single arm
3 doses of the vaccine, on days 0, 30 and 60.
Biological: sm14 antigen plus adjuvant GLA
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, Brazil, 21040900|
|Principal Investigator:||Marilia S Oliveira, MD, MsC||Instituto de Pesquisa Clínica Evandro Chagas (IPEC)|