MedTrace Logo

Sm-p80 Schistosomiasis Challenge Study

NCT05999825 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-10-17

No results posted yet for this study

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

OTHER

Placebo

0.9% Sterile Normal Saline

BIOLOGICAL

Schistosoma mansoni infection

20 viable male Schistosoma mansoni cercariae of the Puerto Rican strain

BIOLOGICAL

Sm-p80 + GLA-SE Vaccine

30 μg Sm-p80 + 5 μg GLA-SE

Sponsors & Collaborators

  • Texas Tech University Health Sciences Center

    collaborator OTHER

  • MRC/UVRI and LSHTM Uganda Research Unit

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Meta Roestenberg, Prof · LUMC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-04-30
Completion
2025-09-30
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05999825 on ClinicalTrials.gov