NCT05999825

Sm-p80 Schistosomiasis Challenge Study

Safety and Preliminary Efficacy of Sm-p80 + GLA-SE (SchistoShield®) Vaccine Against Controlled Human Schistosome Infection in Healthy, Schistosoma-naïve Adults

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn about the Sm-p80 + GLA-SE (Schistoshield®) vaccine in healthy participants who have not had schistosomiasis before. The main questions it aims to answer are: * if the vaccine is safe * if after vaccinated people start producing antibodies * if the vaccine works against schistosomiasis. Participants will receive three vaccines (or placebo) and are then exposed to 20 male Schistosoma cercariae. Afterwards they are treated with praziquantel to cure the infection. Researchers will compare the group vaccinated with Schistoshield® and placebo (fake vaccination) to see if the vaccine has worked.

Conditions

• Schistosoma Mansoni
• Schistosomiasis

Interventions

Type	Name	Description
BIOLOGICAL	Sm-p80 + GLA-SE Vaccine	30 μg Sm-p80 + 5 μg GLA-SE
OTHER	Placebo	0.9% Sterile Normal Saline
BIOLOGICAL	Schistosoma mansoni infection	20 viable male Schistosoma mansoni cercariae of the Puerto Rican strain

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-04-01
• Completion: 2025-09-01
• First posted: 2023-08-21
• Last updated: 2023-10-17

Regulatory

• FDA-regulated drug study