NCT02839161 is a Phase 1 clinical trial of Na-GST-1/Alhydrogel in Hookworm Disease, sponsored by Baylor College of Medicine.

Who is sponsoring NCT02839161?

NCT02839161 is sponsored by Baylor College of Medicine.

What drugs are being tested in NCT02839161?

Interventions in NCT02839161: Na-GST-1/Alhydrogel, Na-APR-1 (M74)/Alhydrogel, Hepatitis B Vaccine.

What condition does NCT02839161 study?

NCT02839161 studies Hookworm Disease, Hookworm Infection.

Is NCT02839161 still recruiting?

NCT02839161 is currently completed. Last updated 2 January 2025.

Are results published for NCT02839161?

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

NCT02839161

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

Randomized, Controlled, Phase 1 Study to Assess Safety and Immunogenicity of Co-administered Hookworm Vaccine Candidates Na-APR-1 (M74)/Alhydrogel® and Na-GST-1/ Alhydrogel® in Gabonese Children

Completed Phase 1 Results posted Last updated 2 January 2025

What this trial tests

Phase 1 trial testing Na-GST-1/Alhydrogel in Hookworm Disease in 60 participants. Completed in 28 March 2019.

Timeline

1 January 2017

Primary endpoint
13 December 2018

28 March 2019

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	60
Start date	1 January 2017
Primary completion	13 December 2018
Estimated completion	28 March 2019
Sites	1 location across Gabon

Drugs / interventions tested

Na-GST-1/Alhydrogel — full drug profile →
Na-APR-1 (M74)/Alhydrogel — full drug profile →
Hepatitis B Vaccine — full drug profile →

Conditions studied

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

Sponsor

Baylor College of Medicine

Who can join

Adults 6 to 10, any sex, with Hookworm Disease or Hookworm Infection. Healthy volunteers can join.

What's being measured

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

Vaccine-Related Adverse Events
Time frame: Day 380
To evaluate the safety and reactogenicity of three different dose concentrations of Na-APR-1 (M74)/Alhydrogel® co-administered with Na-GST-1/Alhydrogel® in healthy Gabonese children.

Sponsor's own description

Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm-exposed children aged 6 to 10 years living in the area of Lambaréné, Gabon. Children will receive three doses of the Na-GST-1/Alhydrogel hookworm vaccine co-administered with the Na-APR-1 (M74)/Alhydrogel hookworm vaccine or the hepatitis B vaccine co-administered with sterile saline. All injections will be delivered intramuscularly (deltoid) on approximately Days 0, 56, and 112 or 180.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety and immunogenicity of the co-administered Na-APR-1 and Na-GST-1 hookworm vaccines in school-aged children in Gabon: a randomised, controlled, observer-blind, phase 1, dose-escalation trial.
Zinsou JF, Diemert DJ, Dejon-Agobé JC, Adégbité BR, et al · · 2024 · cited 10× · PMID 38513684 · DOI 10.1016/s1473-3099(24)00104-x

Verify or expand the search:

Other trials of Na-GST-1/Alhydrogel

Trials testing the same drug.

NCT03172975 — Efficacy of Na-GST-1/Alhydrogel Hookworm Vaccine Assessed by Controlled Challenge Infection · Phase 2 · completed

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 NCT02839161 (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/NCT02839161.

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