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

Oswaldo Cruz Foundation

Status and phase: Completed; Phase 2

Conditions: Schistosomiasis

Treatments: Drug: GLA-SE solution; Biological: Sm14

Study type: Interventional

Funder types: Other

Identifiers

NCT03799510

Sm14 Phase 2b - Sn

Details and patient eligibility

About

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.

Full description

A phase 2b trial, self-contained, open-label, controlled, randomized study in three parallel arms, two of them formed by groups of healthy or infected school children, both receiving three (3) injections at D0, W4 (Week 4), W8; both groups receiving 50 μg Sm14 vaccine candidate solution, combined with 2.5μg GLA-SE. The third group is composed by non-vaccinated infected school children.

Sm14: recombinant protein produced in yeast following Good Manufacturing Practices (GMP) conditions, presented in vials containing 0.55 ml solution Sm14, 0.4 ml solution is diluted with 0.4 ml of GLA (Synthetic Glucopyranosyl lipid A) for intramuscular administration.

Medical examinations are performed at D0 (before injection, 1 hr and 4 hr after), and a safety evaluation at 24 hrs and 48 hrs, after each injection.

Blood analysis: Liver function tests - renal function tests - blood counts, at W-1 before inclusion, and at W9 and W21 during the follow-up.

Blood samples for immune response analysis at D0, W12 and W21.

Enrollment: 95 patients

Sex: All

Ages: 8 to 11 years old

Volunteers: Accepts Healthy Volunteers

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 conditions which in opinion of the PI may potentially represent a danger for the patient to be enrolled.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 3 patient groups

Group 1

Experimental group

Description:

Healthy school children with no infectious history of Schistosomiasis receiving three (3) intramuscular injections of 50 μg Sm14 with 2.5 μg GLA-SE solution at D0, W4, W8 (D=day; W=week). Three-month follow-up (W12, W20).

Treatment:

Biological: Sm14

Drug: GLA-SE solution

Group 2

Experimental group

Description:

School children with an infectious history of S. haematobium and-or S. mansoni and pretreated with 1 dose of Praziquantel (2-4 weeks prior to the first vaccine injection) receiving three (3) intramuscular injections of 50 μg Sm14 with 2.5 μg GLA-SE solution at D0, W4, W8 (D=day; W=week). Three-month follow-up (W12, W20).

Treatment:

Biological: Sm14

Drug: GLA-SE solution

Group 3

No Intervention group

Description:

School children with an infectious history of S. haematobium and S. mansoni and pretreated with 1 dose of Praziquantel (2-4 weeks prior to the first vaccine injection) not receiving vaccine. Control group.