A Phase 1, Randomized, Placebo Controlled Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Vaccine in Healthy Adults
DMID Protocol Number: 18-0018
DMID Funding Mechanism: Vaccine and Treatment Evaluation Units
The study is a Phase 1, randomized, blinded, placebo controlled, dose escalation clinical trial to evaluate the safety, tolerability, and immunogenicity of the Sm-p80 + GLA-SE vaccine candidate in 48 healthy adults. Four treatment groups will be evaluated: A) 100 μg Sm-p80 (unadjuvanted), B) 10 μg Sm-p80 + 5 μg GLA-SE, C) 30 μg Sm-p80 + 5 μg GLA-SE, and D) 100 μg Sm-p80 + 5 μg GLA-SE. Each group will include nine subjects randomized to receive the Sm-p80 product and three subjects to receive placebo and all subjects will receive three intramuscular (IM) injections of 0.5 mL of the designated study product, on Days 1, 29, and 57 (28 days apart).