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Phase I Study of a Vaccine for Severe Acute Respiratory Syndrome (SARS)

NCT00099463 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-07-02

No results posted yet for this 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 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)

Conditions

  • Healthy

Interventions

PROCEDURE

Blood Test

PROCEDURE

Urine Test

PROCEDURE

Physical Exam

DRUG

Vaccine

DRUG

VRC-SRSDNA015-00-VP

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-12-09
Completion
2007-08-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00099463 on ClinicalTrials.gov