Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05999825
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-17
First Post:
2023-08-11
Brief Title:
Sm-p80 Schistosomiasis Challenge Study
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Safety and Preliminary Efficacy of Sm-p80 GLA-SE SchistoShield Vaccine Against Controlled Human Schistosome Infection in Healthy Schistosoma-naïve Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None