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.
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Proportion of Participants With of Any Serious Adverse Events (SAEs)/ Adverse Events of Special Interest (AESI) From the Time of the First Study Vaccination Through the Final Study Visit.
Timeframe: Day 1 through Day 224
Proportion of Participants With Immediate Adverse Events (Reactogenicity Events) Within 60 Min From the Time of Each Study Vaccination
Timeframe: Day 1 through Day 56
Proportion of Participants With Solicited Local and Solicited Systemic AEs as Measured for 7 Days (Inclusive) Following Immunization With the Three Different Dose Formulations.
Timeframe: Day 1 through Day 63
Proportion of Participants With Unsolicited AEs From the Time of Vaccination Until 28 Days Post Immunization With the Three Different Dose Formulations.
Timeframe: Day 1 through Day 84
Proportion of Participants With Clinical Safety Laboratory Adverse Events Measured at 7 Days and 28 Days After Each Study Vaccination.
Timeframe: Day 1 through Day 84