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

NCT03799510 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2019-12-09

No results posted yet for this study

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.

Conditions

  • Schistosomiasis

Interventions

BIOLOGICAL

Sm14

Three 0.5 mL intra-muscular injections of the vaccine solution (50μg Sm14) will be administered on D0, W4, W8 (D = day, W = week).

DRUG

GLA-SE solution

The lot concentration 10μg/mL for injection of 2.5μg GLA-SE/injection.

Sponsors & Collaborators

  • Orygen Biotecnologia SA

    collaborator UNKNOWN

  • Biomedical Research Center EPLS

    collaborator OTHER

  • Access to Advanced Health Institute (AAHI)

    collaborator OTHER

  • Oswaldo Cruz Foundation

    lead OTHER

Principal Investigators

  • Miriam Tendler, MD, PhD · Oswaldo Cruz Foundation

  • Modou DIOP, MD · Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS)

  • Gilles RIVEAU, PharmD, PhD · Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS).

  • Anne-Marie SCHACHT, CRA · Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS).

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-13
Primary Completion
2019-07-01
Completion
2019-08-07

Countries

  • Senegal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03799510 on ClinicalTrials.gov