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NCT01385189 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01385189: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT01385189 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01385189, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Frequency of vaccine-related AEs, graded by severity, for each dose and formulation of Na-GST-1
Interventions
- BIOLOGICAL 10 μg Na-GST-1/Alhydrogel
- BIOLOGICAL 30 μg Na-GST-1/Alhydrogel
- BIOLOGICAL 100 μg Na-GST-1/Alhydrogel
- BIOLOGICAL 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
- BIOLOGICAL 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT01385189 record still lists
NCT01385189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 5 interventions - of which 10 μg Na-GST-1/Alhydrogel is the first listed.
NCT01385189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01385189 about?
NCT01385189 is a clinical study titled "Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant". 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.
What is the current status of trial NCT01385189?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-05. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01385189?
The interventions under investigation include: 10 μg Na-GST-1/Alhydrogel (BIOLOGICAL), 30 μg Na-GST-1/Alhydrogel (BIOLOGICAL), 100 μg Na-GST-1/Alhydrogel (BIOLOGICAL), 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) (BIOLOGICAL), 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01385189?
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 NCT01385189's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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