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NCT00605514 · ClinicalTrials.gov registry record · Phase 1
Ebola and Marburg Virus Vaccines
A Phase 1 study of Marburg Virus Disease and Ebola Virus Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00605514 is a Phase 1 study of Marburg Virus Disease and Ebola Virus Disease that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00605514, a Phase 1 study of Marburg Virus Disease and Ebola Virus Disease, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine if experimental vaccines to prevent Ebola virus infection and Marburg virus infection are safe and what side effects, if any, they cause. 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. Marburg virus infection causes an illness similar to that caused by the Ebola virus. The vaccines used in this study contain genetic material produced in the laboratory that causes the body to make a small amount of either Ebola or Marburg virus proteins. No Ebola or Marburg virus is in the vaccines. Normal healthy volunteers between 18 and 60 years of age may be eligible for this study. Participants are assigned to receive injections of either the Marburg or the Ebola vaccine. The first group of participants will receive the Marburg vaccine and the second group will receive the Ebola vaccine. The injections are given at 4-week intervals (study weeks 0, 4 and 8). They are given into a muscle with a needleless system called the Biojector(Registered Trademark) 2000. Participants keep a diary at home (on paper or electronically) for 5 days, in which they record 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 return to the clinic for follow-up 2 weeks after each injection (weeks 2, 6 and 10). The visits include a check of vital signs, blood and urine tests, medical history and review of medications taken. Additional visits at weeks 12, 24 and 32 include a check of vital signs, medical history and blood tests.
Conditions Studied
Interventions
- DRUG VRC-EBODNA023-00-VP
- DRUG VRC-MARDNA025-00-VP
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-01-25 |
| Est. Completion | 2010-06-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00605514
The ClinicalTrials.gov registry entry for NCT00605514 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 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 5 conditions, with Marburg Virus Disease appearing as the primary indexed condition, and to 2 interventions - of which VRC-EBODNA023-00-VP is the first listed.
NCT00605514 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00605514 about?
NCT00605514 is a clinical study titled "Ebola and Marburg Virus Vaccines". This study will determine if experimental vaccines to prevent Ebola virus infection and Marburg virus infection are safe and what side effects, if any, they cause. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, kidney problems and shock that c...
What is the current status of trial NCT00605514?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2008-01-25. Estimated completion is 2010-06-21.
What conditions does trial NCT00605514 study?
This clinical trial studies the following conditions: Marburg Virus Disease, Ebola Virus Disease, Ebola Vaccines, Marburgvirus, Ebolavirus.
What interventions are being tested in trial NCT00605514?
The interventions under investigation include: VRC-EBODNA023-00-VP (DRUG), VRC-MARDNA025-00-VP (DRUG).
Who is sponsoring clinical trial NCT00605514?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00605514 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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