CompletedPhase 2

Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children

Senegal95 participantsStarted 2018-12-13

Plain-language summary

The clinical trial phase 2b is designed to assess the safety and the specific immune response of the active ingredient (protein + adjuvant) in healthy and then in infected school children from 8 to 11 years of age with intestinal and/or urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis.

Who can participate

Age range

8 Years – 11 Years

Sex

ALL

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: * School children, of public schools in villages of Saint Louis region (Senegal), female or male, 8 to 11 years old (inclusive) at the time of inclusion. * Residence in the area during the period of the study. * Free of obvious/severe health problems except schistosomiasis, as established by clinical examination. * Written informed consent to participate obtained from subject's parents or legal guardian. * Free of obvious/severe health problems except schistosomiasis, established by blood analysis, i.e. hematological exams, liver and renal function tests. * Treated with 40mg/kg Praziquantel (PZQ) before inclusion (W-2 to W-4 before the first injection) in case of infection with S. mansoni and S. haematobium * Children of Group 1: not infected, no schistosomiasis history and living in area/village free of Sm and Sh transmission. * Children Groups 2 \& 3: infected with mansoni or/and haematobium schistosomiasis. Exclusion Criteria: * School child who does not respond to one of the inclusion criteria * Child under 20kg of body weight * Vaccination within 90 days preceding the first dose of Sm14 vaccine candidate, or planned use during the study period. * 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 * Known acute disease. * Other co…

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

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: within 2 days of the administration of the first dose (Day 0)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: Day 30-Day 32: within 2 days of the administration of the second dose (Week 4)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: Days 60-67 : within 7 days of the administration of the third dose (Week 8)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: Day 90: three months after the first injection (Week 12)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: Day 120: four months after the first injection (Week 16)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: Day 150: five months after the first injection (Week 21)

Trial details

NCT IDNCT03799510

SponsorOswaldo Cruz Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-01

View on ClinicalTrials.gov More Schistosomiasis trials