Clinical Trial: A Phase Ib Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel® With or Without GLA-AF for Intestinal Schistosomiasis in Healthy Exposed Adults

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional




Official Title: A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel® With or Without GLA-AF for Intestinal Schistosomiasis in Healthy Exposed Adults

Brief Summary: The study will be conducted as a randomized, controlled, double blind Phase 1b dose-escalating clinical trial in up to 60 healthy adult males and non-pregnant females living in the S. mansoni-endemic area of Americaninhas, Brazil. The primary objective of this trial is to assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel® (10mcg, 30mcg, or 100mcg) vaccine with or without GLA-AF given as three doses administered on Days 1, 57, and 113.