Anti-Schistosomiasis Sm14-vaccine in Senegal (NCT05658614) | Clinical Trial Compass
UnknownPhase 2
Anti-Schistosomiasis Sm14-vaccine in Senegal
Senegal120 participantsStarted 2022-07-01
Plain-language summary
Previous clinical trials have already demonstrated the safety of the candidate vaccine in adults as well as in children, in good health or infected with schistosomiasis. Regarding the induced immune response, more than 80% of vaccinated subjects were seroconverted after three vaccine injections. The induced immune response was substantial but transient. In order to obtain a more lasting immune response, the investigator will experiment with a new vaccination schedule (2 injections 1-month interval and the 3rd injection 5 months after the first dose), versus the vaccine schedule initially used (3 injections at 1-month interval).
This trial will be the last phase 2 before testing the efficacy of the rSm14 vaccine candidate.
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:
* Man living in villages in the Saint Louis region where schistosomiasis is endemic.
* Having an infectious history of schistosomiasis.
* Adult between 18 and 49 years old at the time of the first injection.
* Have received pre-treatment with PZQ four to eight weeks before inclusion.
* Consent signed by the volunteer after information.
* Satisfactory state of health, confirmed on clinical examination and following biological assessment (Vpi / W-1).
* Available for the duration of the trial.
* To be negative to the Covid-19 antigenic test
Exclusion Criteria (Non inclusion criteria) :
* Subject not meeting one of the inclusion criteria.
* Participation to a previous anti-schistosomiasis vaccine clinical trial.
* Participation in another ongoing clinical research
* Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immune modulating drugs.
* Known hypersensitivity to any component present in the Sm14 vaccine, or to any given vaccine, and / or history of allergic disease.
* Acute illness at the time of inclusion.
* Other conditions which, according to the PI, can potentially represent a danger to the subject to be included.
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.