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 range8 Years – 11 Years

SexALL

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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…

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