Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions (NCT03041766) | Clinical Trial Compass
CompletedPhase 2
Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions
Senegal30 participantsStarted 2016-12-06
Plain-language summary
The clinical trial phase 2a is designed to assess the safety of the active ingredient (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49 years of age with a history of infection with intestinal and urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis. Two arms in the study will test different doses of GLA-SE adjuvant (2.5 and 5 μg). This phase IIA in adults is considered to be a preliminary step in safety before starting trials in children in endemic areas to S. mansoni or S. haematobium, target population of the vaccine.
Who can participate
Age range
18 Years – 49 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Timeframe: within 7 days of the administration of the first dose
2
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: D30-D37: within 7 days of the administration of the second dose
3
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: D60-67 : within 7 days of the administration of the third dose
4
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: D90 : three months after the first injection
5
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: D120 : four months after the first injection