Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
NCT ID:
NCT03041766
Eligibility Criteria:
Inclusion Criteria:
* Adults, male, 18 to 49 years old (inclusive) at the time of inclusion.
* Living in one of selected villages in Saint-Louis Region (Senegal).
* Free of obvious/severe health problems except schistosomiasis, as established by clinical examination and blood analysis, i.e. hematological exams, liver and renal function tests.
* Written informed consent to participate obtained
* Treated with 40mg/kg Praziquantel (PZQ) before inclusion (W-5 to W-4 before the first injection) in case of infection with S. mansoni and S. haematobium
* Residence in the area during the period of the study.
Exclusion Criteria:
* Adult who does not respond to one of the inclusion criteria
* Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immuno-modifying drugs.
* Known hypersensitivity to any component in the Sm14 vaccine or history of allergic disease.
* Knowledge of non-infectious chronic disease
* Acute disease at time of enrollment.
* Other conditions which in opinion of the PI may potentially represent a danger for the patient to be enrolled.
* Non residence in the study area or intent to move during the study period
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT03041766
Study Brief:
Protocol Section:
NCT03041766