Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01717950 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01717950: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT01717950 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
NCT01717950, 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
Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has protected animals from infection in challenge studies. This study will evaluate the safety and immunogenicity of two formulations of Na-APR-1 (M74) in healthy adult volunteers when co-administered with different concentrations of the immunostimulant GLA-AF.
Primary Outcome
The frequency of immediate, systemic, and local injection site adverse events will be summarized. Adverse events will be assessed by study team members at 1 hour post-vaccination as well as 3, 7, 14, and 28 days following each vaccination. In addition, study participants will be asked to complete symptom diaries for the 7 days after each vaccination.
Interventions
- BIOLOGICAL Na-APR-1 (M74)/Alhydrogel®
- BIOLOGICAL Gluco-Pyranosylphospho-Lipid A Aqueous Formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT01717950 record still lists
NCT01717950 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 2 interventions - of which Na-APR-1 (M74)/Alhydrogel® is the first listed.
NCT01717950 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01717950 about?
NCT01717950 is a clinical study titled "Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults". Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has protected animals from infection in challenge studies. This study will evaluate the safety and immunogenicity of t...
What is the current status of trial NCT01717950?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2013-09. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01717950?
The interventions under investigation include: Na-APR-1 (M74)/Alhydrogel® (BIOLOGICAL), Gluco-Pyranosylphospho-Lipid A Aqueous Formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT01717950?
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 NCT01717950'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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia