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

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 6, 2016

Primary Completion Date

April 6, 2017

Study Completion Date

June 2, 2017

Conditions
Schistosomiasis
Interventions
BIOLOGICAL

Sm14

Three 0.5 mL intra-muscular injections of the vaccine solution (50µg Sm14) will be administered on D0, W4, W8 (D = day, W = week).

DRUG

GLA-SE solution

Two (2) adjuvant concentrations will be made and packaged at 0.4 mL/vial, per GMP standards. One lot at the concentration of 10µg/mL for injection in the first cohort at 2.5µg GLA-SE/injection and one lot at the concentration of 20µg/mL for the second cohort intended to receive 5.0µg of GLA-SE/injection

Trial Locations (1)

BP226

Biomedical Research Center EPLS, Saint-Louis

All Listed Sponsors
collaborator

Orygen Biotecnologia SA

UNKNOWN

collaborator

Biomedical Research Center EPLS

OTHER

collaborator

Access to Advanced Health Institute (AAHI)

OTHER

lead

Oswaldo Cruz Foundation

OTHER

NCT03041766 - Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions | Biotech Hunter | Biotech Hunter