MedTrace Logo

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the rSm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar

NCT05762393 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-29

Study results available
· View outcomes & findings →

Summary

The goal of this phase 1b, multicenter, randomized, placebo-controlled, observer-blinded, dose-escalation study is to assess the safety, tolerability, and immunogenicity of a three-dose regimen, spaced four weeks apart, given intramuscularly in healthy adults (20-59 years old). Three different dose formulations of the study product with varying antigen contents will be investigated.

A total of 120 eligible participants will be recruited in 3 sequential cohorts (A, B, and C) in Burkina Faso (N=60) and in Madagascar (N=60). Cohort A will receive the low-dose antigen formulation (10 µg) or placebo, Cohort B will receive the medium-dose antigen formulation (30 µg) or placebo, and Cohort C will receive the high-dose antigen formulation (100 µg) or placebo; all antigens with 5 μg adjuvant (GLA-SE). In each cohort, volunteers will be randomized in a blinded manner into one of two arms, candidate vaccine or placebo, by a 3:1 ratio. A subset of five out of 20 subjects in each cohort will be sampled by convenience to enable us to further characterize the immune response using the peripheral blood mononuclear cells (PBMC). The Primary Objective of the study is to evaluate the safety and tolerability of 3 different dose formulations (low dose, medium dose, and high dose) of SchistoShield® vaccine given intramuscularly on D0, D28 and D56 to healthy participants 20 to 59 years of age in Burkina Faso and Madagascar.

Conditions

  • Schistosomiasis

Interventions

BIOLOGICAL

rSm-p80 + GLA-SE

Combination vaccine containing rSm-p80 antigen and GLA-SE adjuvant.

Sponsors & Collaborators

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Florian Marks · International Vaccine Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-17
Primary Completion
2025-05-19
Completion
2025-05-19
FDA Drug
Yes

Countries

  • Burkina Faso
  • Madagascar

Study Locations

More Related Trials

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 NCT05762393 on ClinicalTrials.gov