A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults

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(R) (10mcg, 30mcg, or 100mcg) vaccine with or without AP 10-701 given as three doses administered on Days 1, 57, and 113.

Timeline

Start

2018-05-20

Primary completion

2019-11-14

Completion

2019-11-14

Publications

• Diemert DJ, Correa-Oliveira R, Fraga CG, Talles F, Silva MR, Patel SM, Galbiati S, Kennedy JK, Lundeen JS, Gazzinelli MF, Li G, Hoeweler L, Deye GA, Bottazzi ME, Hotez PJ, El Sahly HM, Keitel WA, Bethony J, Atmar RL. A randomized, controlled Phase 1b trial of the Sm-TSP-2 Vaccine for intestinal schistosomiasis in healthy Brazilian adults living in an endemic area. PLoS Negl Trop Dis. 2023 Mar 30;17(3):e0011236. doi: 10.1371/journal.pntd.0011236. eCollection 2023 Mar.

Drugs

Indications