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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 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01385189
The ClinicalTrials.gov registry entry for NCT01385189 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which 10 μg Na-GST-1/Alhydrogel is the first listed.
NCT01385189 reports 0 study locations.
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.
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