NCT01385189 is a Phase 1 clinical trial of 10 μg Na-GST-1/Alhydrogel in Hookworm Infection, sponsored by Baylor College of Medicine.

Who is sponsoring NCT01385189?

NCT01385189 is sponsored by Baylor College of Medicine.

What drugs are being tested in NCT01385189?

Interventions in NCT01385189: 10 μg Na-GST-1/Alhydrogel, 30 μg Na-GST-1/Alhydrogel, 100 μg Na-GST-1/Alhydrogel, 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg), 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg), 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg), 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg).

What condition does NCT01385189 study?

NCT01385189 studies Hookworm Infection, Hookworm Disease.

Is NCT01385189 still recruiting?

NCT01385189 is currently completed. Last updated 2 January 2025.

Are results published for NCT01385189?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-01-02 · How we verify

NCT01385189

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I Study of the Safety and Immunogenicity of Na-GST-1/Alhydrogel® With Different Doses of the Novel Immunostimulant GLA-AF in Healthy Adults

Completed Phase 1 Results posted Last updated 2 January 2025

What this trial tests

Phase 1 trial testing 10 μg Na-GST-1/Alhydrogel in Hookworm Infection in 40 participants. Completed in 1 June 2015.

Timeline

1 May 2012

Primary endpoint
1 January 2015

1 June 2015

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	40
Start date	1 May 2012
Primary completion	1 January 2015
Estimated completion	1 June 2015
Sites	1 location across United States

Drugs / interventions tested

10 μg Na-GST-1/Alhydrogel — full drug profile →
30 μg Na-GST-1/Alhydrogel — full drug profile →
100 μg Na-GST-1/Alhydrogel — full drug profile →
10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) — full drug profile →
30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) — full drug profile →

Conditions studied

Hookworm Infection — all drugs for Hookworm Infection →
Hookworm Disease — all drugs for Hookworm Disease →

Sponsor

Baylor College of Medicine

Who can join

Adults 18 to 45, any sex, with Hookworm Infection or Hookworm Disease. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Immediate Vaccine Related Adverse Events
Time frame: 2 hours post vaccination
Frequency of vaccine-related AEs, graded by severity, for each dose and formulation of Na-GST-1

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults.
Diemert DJ, Freire J, Valente V, Fraga CG, et al · · 2017 · cited 60× · PMID 28464026 · DOI 10.1371/journal.pntd.0005574
Advances in neglected tropical disease vaccines: Developing relative potency and functional assays for the Na-GST-1/Alhydrogel hookworm vaccine.
Brelsford JB, Plieskatt JL, Yakovleva A, Jariwala A, et al · · 2017 · cited 11× · PMID 28192438 · DOI 10.1371/journal.pntd.0005385
Advances in vaccine adjuvant development and future perspectives.
Sinani G, Şenel S. · · 2025 · cited 10× · PMID 40536024 · DOI 10.1080/10717544.2025.2517137

Verify or expand the search:

Other Baylor College of Medicine trials

Trials by the same sponsor.

NCT07513194 — GPC3 CAR T Cells With IL-15 and IL-21 for Recurrent ATRT and CNS Rhabdoid Tumors (RADIANT) · Phase 1 · not yet recruiting
NCT05855824 — Toddler Biomarker of Nutrition Study · NA · not yet recruiting
NCT06738628 — Disposable Endoscope Platform in Third Space Endoscopic Procedures · not yet recruiting
NCT06834997 — Dronabinol As an Adjunct for Reducing Pain (DARP)-Texas Children's Hospital · Phase 2 · withdrawn
NCT07387614 — WEB-BASED SUPPORT PROGRAM FOR CAREGIVERS OF VETERANS WITH DEMENTIA DISCHARGED FROM SKILLED NURSING FACILITIES TO HOME · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01385189 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Baylor College of Medicine
Last refreshed: 2 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01385189.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing