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Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions

NCT03041766 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-12-14

No results posted yet for this study

Summary

The clinical trial phase 2a is designed to assess the safety of the active ingredient (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49 years of age with a history of infection with intestinal and urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis. Two arms in the study will test different doses of GLA-SE adjuvant (2.5 and 5 μg). This phase IIA in adults is considered to be a preliminary step in safety before starting trials in children in endemic areas to S. mansoni or S. haematobium, target population of the vaccine.

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

Two (2) adjuvant concentrations will be made and packaged at 0.4 mL/vial, per GMP standards. One lot at the concentration of 10µg/mL for injection in the first cohort at 2.5µg GLA-SE/injection and one lot at the concentration of 20µg/mL for the second cohort intended to receive 5.0µg of 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

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

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-06
Primary Completion
2017-04-06
Completion
2017-06-02

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 NCT03041766 on ClinicalTrials.gov