Who is sponsoring NCT02476773?

NCT02476773 is sponsored by Baylor College of Medicine.

What drugs are being tested in NCT02476773?

Interventions in NCT02476773: Na-GST-1/Alhydrogel plus GLA-AF, Na-APR-1 (M74)/Alhydrogel, Na-APR-1 (M74)/Alhydrogel plus GLA-AF, Sterile Saline Placebo.

What condition does NCT02476773 study?

NCT02476773 studies Hookworm Infection, Hookworm Disease.

Is NCT02476773 still recruiting?

NCT02476773 is currently completed. Last updated 29 November 2019.

Last reviewed 2019-11-29 · How we verify

NCT02476773

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

Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel® in Brazilian Adults

Completed Phase 1 Last updated 29 November 2019

What this trial tests

Phase 1 trial testing Na-GST-1/Alhydrogel plus GLA-AF in Hookworm Infection in 60 participants. Completed in 1 December 2017.

Timeline

1 January 2016

Primary endpoint
1 June 2017

1 December 2017

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 2016
Primary completion	1 June 2017
Estimated completion	1 December 2017
Sites	1 location across Brazil

Drugs / interventions tested

Na-GST-1/Alhydrogel plus GLA-AF — full drug profile →
Na-APR-1 (M74)/Alhydrogel — full drug profile →
Na-APR-1 (M74)/Alhydrogel plus GLA-AF — full drug profile →
Sterile Saline Placebo

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.

Frequency of solicited injection site and systemic reactogenicity, graded by severity, on the day of each study vaccination through 14 days after each study vaccination.
Time frame: 14 days post-vaccination
Frequency of study vaccine-related serious adverse events from the time of the first study vaccination through approximately 9 months after the last study vaccination.
Time frame: Day 380
Frequency of clinical safety laboratory adverse events.
Time frame: Day 380
Frequency of unsolicited adverse events, graded by severity, from the time of each study vaccination through approximately 1 month after each study vaccination.
Time frame: 30 days post-vaccination
Frequency of new-onset chronic medical conditions through approximately 9 months after the third study vaccination.
Time frame: Day 380
Frequency of Adverse Events of Special Interest through approximately 9 months after the third study vaccination.
Time frame: Day 380

Sponsor's own description

Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus hookworm life cycle that are thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination wtih recombinant GST-1 or APR-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Brazilian adults living in an area of endemic hookworm infection.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Baylor College of Medicine trials

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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 NCT02476773 (US National Library of Medicine, public domain)
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: 29 November 2019

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/NCT02476773.

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