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Anti-Schistosomiasis Sm14-vaccine in Senegal

NCT05658614 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-12-21

No results posted yet for this study

Summary

Previous clinical trials have already demonstrated the safety of the candidate vaccine in adults as well as in children, in good health or infected with schistosomiasis. Regarding the induced immune response, more than 80% of vaccinated subjects were seroconverted after three vaccine injections. The induced immune response was substantial but transient. In order to obtain a more lasting immune response, the investigator will experiment with a new vaccination schedule (2 injections 1-month interval and the 3rd injection 5 months after the first dose), versus the vaccine schedule initially used (3 injections at 1-month interval).

This trial will be the last phase 2 before testing the efficacy of the rSm14 vaccine candidate.

Conditions

  • Schistosomiasis Mansoni
  • Schistosomiasis Haematobium
  • Vaccination; Infection

Interventions

BIOLOGICAL

Sm14 recombinant vaccine+ GLA-SE adjuvant

rSm14 - recombinant protein (GMP produced) - 50ug / injection GLA-SE- synthetic Glucopyranosyl lipid A in stable emulsion: 2.5ug / injection

Sponsors & Collaborators

  • Oswaldo Cruz Foundation

    lead OTHER

Principal Investigators

  • Gilles RIVEAU, PharmD PhD · Biomedical Research Center 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
2022-07-01
Primary Completion
2023-09-15
Completion
2023-12-31

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 NCT05658614 on ClinicalTrials.gov