Efficacy of Na-GST-1/Alhydrogel Hookworm Vaccine Assessed by Controlled Challenge Infection

Phase 2 Completed 39 enrolled Baylor College of Medicine George Washington University · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2018-03-01
Primary completion: 2024-12-31
Completion: 2025-01-30

Outcome

Missed primary endpoint

paper Na-GST-1/Al (five [56%] of nine), and Na-GST-1/Al-AP (six [60%] of ten) groups, although differences were not significant. PMID 41861834 ↗

Publications

DiRosato CK, Malkin EM, Lee SM, Erwin G, Hoeweler L, Scholte L, Bottazzi ME, Pritchard DI, Hotez PJ, Bethony JM, Diemert DJ. Na-GST-1 adsorbed on Alhydrogel co-administered with different Toll-like receptor agonists in hookworm-naive adults using a controlled human infection model in the USA: a phase 2, double-blind, randomised controlled trial. Lancet Infect Dis. 2026 Mar 17:S1473-3099(26)00018-6. doi: 10.1016/S1473-3099(26)00018-6. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GLA-AF	Other / unclassified	5 ug	Intramuscular
Subject	Na-GST-1	Protein / enzyme biologic	100 ug	Intramuscular
Subject	agatolimod	Oligonucleotide (other)	500 ug	Intramuscular
Background	Albendazole	Small molecule	400 mg	Oral