Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant

Phase 1 Completed 40 enrolled Baylor College of Medicine Children's National Research Institute · collab George Washington University · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study is designed to evaluate the safety, reactogenicity, and immunogenicity of Na-GST-1 adsorbed to Alhydrogel® with or without two different dose concentrations of a novel adjuvant, GLA-AF (1 µg or 5 μg) among healthy adult volunteers.

Timeline

Start: 2012-05
Primary completion: 2015-01
Completion: 2015-06

Publications

Diemert DJ, Freire J, Valente V, Fraga CG, Talles F, Grahek S, Campbell D, Jariwala A, Periago MV, Enk M, Gazzinelli MF, Bottazzi ME, Hamilton R, Brelsford J, Yakovleva A, Li G, Peng J, Correa-Oliveira R, Hotez P, Bethony J. Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults. PLoS Negl Trop Dis. 2017 May 2;11(5):e0005574. doi: 10.1371/journal.pntd.0005574. eCollection 2017 May.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GLA-AF	Other / unclassified	1 ug	Intramuscular
Subject	GLA-AF	Other / unclassified	5 ug	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
Background	Aluminum hydroxide	Unknown	—	Intramuscular

Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant

Summary

Timeline

Publications

Drugs

Indications