Covid 19 Research using Clinical Trials (Home Page)
VRC-SRSDNA015-00-VPWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (5)
Correlated MeSH Terms (9)
Correlated HPO Terms (0)
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There is one clinical trial.
Clinical Trials
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 examination (day 0 and weeks 2, 4, 6, 8, 10 and 12)
- Blood draw (study day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32)
- Pregnancy test for women (day 0 and weeks 4, 8 and 32)
- Urine sample (day 0 and weeks 2, 4, 6, 8, 10)
NCT00099463 Healthy Procedure: Blood Test Procedure: Urine Test Procedure: Physical Exam Drug: Vaccine Drug: VRC-SRSDNA015-00-VP
No related HPO nodes (Using clinical trials)