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NCT02143518 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity Study of Na-GST-1 With or Without CpG
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02143518: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT02143518 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02143518, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Na-GST-1 is a protein expressed during the adult stage of the hookworm life cycle that is thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant GST-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of two formulations of Na-GST-1 in healthy adult volunteers when co-administered with the immunostimulant CpG 10104, a Toll-like Receptor-9 agonist.
Primary Outcome
The frequency of immediate, systemic, and local injection site adverse events, graded by severity, for Na-GST-1/Alhydrogel administered alone or in combination with CpG 10104
Interventions
- BIOLOGICAL Na-GST-1/Alhydrogel®
- BIOLOGICAL CpG 10104
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
What the finished NCT02143518 record still lists
NCT02143518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Na-GST-1/Alhydrogel® is the first listed.
NCT02143518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02143518 about?
NCT02143518 is a clinical study titled "Safety and Immunogenicity Study of Na-GST-1 With or Without CpG". Na-GST-1 is a protein expressed during the adult stage of the hookworm life cycle that is thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant GST-1 has protected dogs and hamsters from infection in challenge studies. This ...
What is the current status of trial NCT02143518?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2014-10. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02143518?
The interventions under investigation include: Na-GST-1/Alhydrogel® (BIOLOGICAL), CpG 10104 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02143518?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02143518's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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