Who is sponsoring NCT03041766?

NCT03041766 is sponsored by Oswaldo Cruz Foundation.

What condition does NCT03041766 study?

NCT03041766 studies Schistosomiasis.

What drugs are being tested in NCT03041766?

Interventions: Sm14, GLA-SE solution.

What is the status of NCT03041766?

NCT03041766 is currently COMPLETED.

Last reviewed 2017-12-14 · How we verify

Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions

NCT03041766 PHASE2 COMPLETED

The clinical trial phase 2a is designed to assess the safety of the active ingredient (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49 years of age with a history of infection with intestinal and urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis. Two arms in the study will test different doses of GLA-SE adjuvant (2.5 and 5 μg). This phase IIA in adults is considered to be a preliminary step in safety before starting trials in children in endemic areas to S. mansoni or S. haematobium, target population of the vaccine.

Details

Lead sponsor	Oswaldo Cruz Foundation
Phase	PHASE2
Status	COMPLETED
Enrolment	30
Start date	Tue Dec 06 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Jun 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Schistosomiasis

Interventions

Sm14
GLA-SE solution

Countries

Senegal