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COMPLETED
NCT05762393
PHASE1

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

Sponsor: International Vaccine Institute

View on ClinicalTrials.gov

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.

Official title: A Phase 1b, Multicenter, Randomized, Placebo-controlled, Observer-blinded, Dose-escalation 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

Key Details

Gender

All

Age Range

20 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-11-17

Completion Date

2025-05-19

Last Updated

2026-04-29

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

rSm-p80 + GLA-SE

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

Locations (2)

Groupe de Recherche Action en Santé (GRAS)

Ouagadougou, Burkina Faso

Madagascar Institute for Vaccine Research (University of Antananarivo)

Antananarivo, Madagascar