NCT02337855 - A Phase I Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel® With or Without GLA-AF for Intestinal Schistosomiasis in Healthy Adults | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 4, 2015

Primary Completion Date

January 27, 2017

Study Completion Date

January 27, 2017

Conditions

Schistosomiasis

Interventions

OTHER

Placebo

Placebo: normal saline for parenteral administration. Group C. Group F, and Group I: single dose intramuscular (IM) Placebo (normal saline (0.9% NaCl) on Day 1, 57 and 113.

BIOLOGICAL

Sm-TSP-2/Alhydrogel

Sm-TSP-2/Alhydrogel. Group A: single dose IM 10mcg Sm-TSP-2/Alhydrogel® on Day1, 57 and 113. Group D: single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113. Group G: single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113.

BIOLOGICAL

Sm-TSP-2/Alhydrogel/GLA-AF

Sm-TSP-2/Alhydrogel/GLA-AF. Group B: single dose intramuscular (IM) 10mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113. Group E: single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113. Group H: single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113.

Trial Locations (1)

77030-3411

Baylor College of Medicine - Molecular Virology and Microbiology, Houston

All Listed Sponsors

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH