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NCT00374309 · ClinicalTrials.gov registry record · Phase 1
Experimental Vaccine for Prevention of Ebola Virus Infection
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT00374309 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants.
The verdict
NCT00374309, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study will determine if an experimental vaccine to prevent Ebola virus infection is safe and what side effects, if any, it causes. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can lead to death. The vaccine used in this study contains man-made genetic material similar to one part of the Ebola virus, which is designed to stimulate an immune response to the virus. The vaccine itself cannot cause Ebola virus infection because it does not contain any Ebola virus. Participants are assigned to one of three groups as they enter into the study. Of the first 16 people in the study, 12 receive the lowest study dose of vaccine and 4 receive placebo (an inactive substance). If this dose is safe, then of the next 16 people who enter the study, 12 receive a higher dose of the vaccine, and the remaining 4 receive placebo. If this dose is safe, the final 12 people in the last group of 16 receive the highest study dose, and 4 receive placebo. The vaccine is given as a single injection in the arm on the day of enrollment. Participants keep a diary for 5 days, recording their temperature, symptoms and any reaction at the injection site. They call a study nurse the day after vaccination to report how they feel, and they return to the clinic approximately six times for follow-up evaluations. These visits may include a check of vital signs, physical examination, blood and urine tests, or other medical tests if needed. ...
Interventions
- DRUG VRC-EBOADV018-00-VP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2006-09-05 |
| Est. Completion | 2009-05-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00374309
The ClinicalTrials.gov registry entry for NCT00374309 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which VRC-EBOADV018-00-VP is the first listed.
NCT00374309 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00374309 about?
NCT00374309 is a clinical study titled "Experimental Vaccine for Prevention of Ebola Virus Infection". This study will determine if an experimental vaccine to prevent Ebola virus infection is safe and what side effects, if any, it causes. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can lead to death. The vaccin...
What is the current status of trial NCT00374309?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2006-09-05. Estimated completion is 2009-05-05.
What interventions are being tested in trial NCT00374309?
The interventions under investigation include: VRC-EBOADV018-00-VP (DRUG).
Who is sponsoring clinical trial NCT00374309?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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