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| Name | Class |
|---|---|
| Financiadora de Estudos e Projetos | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | 3 doses of the vaccine, on days 0, 30 and 60. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sm14 antigen plus adjuvant GLA | Biological | Healthy adults will receive 3 doses of the vaccine, on days 0, 30 and 60. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the vaccine | Safety and tolerability of the vaccine (sm14 antigen plus GLA adjuvant) against schistosomiasis in health adults | 4 months after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of seroconversion | Proportion of seroconversion for sm14 antigen 30 days after the complete vaccinal schedule (3 doses, 30 days apart) | 30 days after the third vaccine dose |
| Cellular immune response to sm-14 vaccination in health adults |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marilia S Oliveira, MD, MsC | Instituto de Pesquisa ClĂnica Evandro Chagas (IPEC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Pesquisa ClĂnica Evandro Chagas (IPEC) - Fiocruz | Rio de Janeiro | Rio de Janeiro | 21040900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26571311 | Derived | Santini-Oliveira M, Coler RN, Parra J, Veloso V, Jayashankar L, Pinto PM, Ciol MA, Bergquist R, Reed SG, Tendler M. Schistosomiasis vaccine candidate Sm14/GLA-SE: Phase 1 safety and immunogenicity clinical trial in healthy, male adults. Vaccine. 2016 Jan 20;34(4):586-594. doi: 10.1016/j.vaccine.2015.10.027. Epub 2015 Nov 10. |
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| ID | Term |
|---|---|
| D012552 | Schistosomiasis |
| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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Determine the cellular immune responses and their correlation to the development and magnitude of humoral responses
| 30 days after the third vaccine dose |
| D000079426 |
| Vector Borne Diseases |