Clinical Trial

Hookworm Vaccine Assessed by Controlled Challenge Infection

Study Description

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

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Biological - Na-GST-1/Alhydrogel

Recombinant ˆNecator americanusˆ Glutathione-S Transferase adjuvanted with Alhydrogel

Biological - Na-GST-1/Alhydrogel + CPG 10104

Recombinant ˆNecator americanusˆ Glutathione-S Transferase adjuvanted with Alhydrogel and co-administered with CPG 10104, a synthetic oligodeoxynucleotide

Biological - Na-GST-1/Alhydrogel + GLA-AF

Recombinant ˆNecator americanusˆ Glutathione-S Transferase adjuvanted with Alhydrogel and co-administered with an aqueous formulation of Glucopyranosyl-Lipid A (GLA-AF)

Biological - Placebo

Physiological sterile saline solution

Drug - Albendazole

Treatment with 3 daily oral doses of 400 mg albendazole at end of study.

Necator americanus Larval Inoculum

50 infectious Necator americanus larvae applied via dermal application (challenge infection).

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03172975

ParticipAid ID

YaOvpe