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

NCT03172975 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-03-12

Study results available
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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.

Conditions

  • Hookworm Infections

Interventions

BIOLOGICAL

Na-GST-1/Alhydrogel

Recombinant Necator americanus Glutathione-S Transferase adjuvanted with Alhydrogel

BIOLOGICAL

Na-GST-1/Alhydrogel + CPG 10104

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

BIOLOGICAL

Na-GST-1/Alhydrogel + GLA-AF

Recombinant Necator americanus 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.

OTHER

Necator americanus Larval Inoculum

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

Sponsors & Collaborators

  • George Washington University

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • David Diemert, MD · George Washington University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2024-12-31
Completion
2025-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03172975 on ClinicalTrials.gov