drugset / Trial / NCT01261130

Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With or Without Additional Adjuvant in Brazilian Adults

NCT01261130

Phase 1 Completed 102 enrolled Baylor College of Medicine
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This two part study will evaluate the safety and immunogenicity of two formulations of Na-GST-1, first in hookworm-naïve individuals using an open-label design, and then in adults living in an area of endemic hookworm infection using a randomized, double-blind design. The two formulations to be evaluated are Na-GST-1 adsorbed to an adjuvant, Alhydrogel®, and Na-GST-1 adsorbed to Alhydrogel® and administered with GLA-AF.

Timeline

Start
2011-11
Primary completion
2014-08
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Butang® Vaccine Intramuscular
Subject Na-GST-1 Protein / enzyme biologic 10 ug Intramuscular
Subject Na-GST-1 Protein / enzyme biologic 30 ug Intramuscular
Subject Na-GST-1 Protein / enzyme biologic 100 ug Intramuscular