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NCT00099463 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of a Vaccine for Severe Acute Respiratory Syndrome (SARS)
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00099463 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants.
The verdict
NCT00099463, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will test whether an experimental vaccine to protect against severe acute respiratory syndrome (SARS) is safe, causes any side effects, and causes an immune response. SARS affects the respiratory system, usually starting with fever and muscle aches. Patients may get a dry cough and have difficulty breathing. Infection may be mild, but it can lead to death. Vaccines contain substances from an infectious agent, such as a virus, that, when injected into a person's body, stimulates production of antibodies that create resistance, or immunity, to that agent. The vaccine in this study contains genetic material (DNA) that codes for a protein found in the virus that causes SARS. Injected into a muscle, it instructs the body to make a small amount of a SARS protein. The vaccine is made from just one small part of the code for one SARS protein; a person cannot get SARS from the vaccine. Normal volunteers between 18 and 50 years of age who are in general good health may be eligible for this 32-week study. Candidates are screened with a physical examination and blood and urine tests. Participants have nine clinic visits during the study. They receive three vaccine injections, given with a system called the Bioinjector 2000® (Registered Trademark), which delivers the vaccine through the skin without the use of a needle. Following each injection, participants take home a diary card, on which they record their temperature and any vaccine side effects daily for 5 days. Participants must immediately report any symptoms to a study physician, and, if necessary, go to the clinic for an examination. Participants have the following tests and procedures: * Vaccine injections (study day 0, around week 4, and around week 8, with at least 21 days between injections) * Medical history and, if needed, physical examination (study day 0 and weeks 2, 4, 6, 8, 10, 12, 24, and 32) * Check of vital signs and weight (study day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32) * Lymph node exa
Interventions
- PROCEDURE Blood Test
- PROCEDURE Urine Test
- PROCEDURE Physical Exam
- DRUG Vaccine
- DRUG VRC-SRSDNA015-00-VP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2004-12-09 |
| Est. Completion | 2007-08-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00099463
The ClinicalTrials.gov registry entry for NCT00099463 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 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 5 interventions - of which Blood Test is the first listed.
NCT00099463 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00099463 about?
NCT00099463 is a clinical study titled "Phase I Study of a Vaccine for Severe Acute Respiratory Syndrome (SARS)". This study will test whether an experimental vaccine to protect against severe acute respiratory syndrome (SARS) is safe, causes any side effects, and causes an immune response. SARS affects the respiratory system, usually starting with fever and muscle aches. Patients may get a dry cough and have d...
What is the current status of trial NCT00099463?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2004-12-09. Estimated completion is 2007-08-22.
What interventions are being tested in trial NCT00099463?
The interventions under investigation include: Blood Test (PROCEDURE), Urine Test (PROCEDURE), Physical Exam (PROCEDURE), Vaccine (DRUG), VRC-SRSDNA015-00-VP (DRUG).
Who is sponsoring clinical trial NCT00099463?
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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