Phase 2 Study to Assess the Safety, Efficacy and Immunogenicity of Na-GST-1/Alhydrogel Co-administered With Different Toll-Like Receptor Agonists in Hookworm- Naïve Adults
Who is this study for? Adult patients with Hookworm Infection
What treatments are being studied? Na-GST-1 Hookworm Vaccine
Status: Completed
Location: See location...
Intervention Type: Biological, Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study evaluates the efficacy, safety and immunogenicity of different formulations of the Na-GST-1 hookworm vaccine using a controlled human hookworm infection model in healthy, hookworm-naive adults.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:
• Males and non-pregnant females between 18 and 45 years, inclusive.
• Good general health as determined by means of the screening procedures1.
• Available for the duration of individual subject study participation (14 months).
• Willingness to participate in the study as evidenced by signing the informed consent document.
• Able to understand and comply with planned study procedures.
Locations
United States
Washington, D.c.
George Washington University
Washington D.c.
Time Frame
Start Date: 2018-03-01
Completion Date: 2025-01-30
Participants
Target number of participants: 39
Treatments
Experimental: Na-GST-1/Alhydrogel
100 µg Na-GST-1/Alhydrogel administered intramuscularly in the deltoid on study days 0, 56 and 112 followed by controlled human hookworm infection with 50 infectious Necator americanus larvae on study day 140.
Experimental: Na-GST-1/Alhydrogel + CPG 10104
100 µg Na-GST-1/Alhydrogel co-administered with 500 µg CPG 10104 delivered intramuscularly in the deltoid on study days 0, 56 and 112 followed by controlled human hookworm infection with 50 infectious Necator americanus larvae on study day 140.
Experimental: Na-GST-1/Alhydrogel + GLA-AF
100 µg Na-GST-1/Alhydrogel co-administered with 5 µg GLA-AF delivered intramuscularly in the deltoid on study days 0, 56 and 112 followed by controlled human hookworm infection with 50 infectious Necator americanus larvae on study day 140.
Placebo_comparator: Saline Placebo
Sterile saline placebo delivered intramuscularly in the deltoid on study days 0, 56 and 112 followed by controlled human hookworm infection with 50 infectious Necator americanus larvae on study day 140.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), George Washington University
Leads: Baylor College of Medicine