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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

About this trial record page

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Public field values for ClinicalTrials.gov record NCT00099463, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.

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Last update posted Jul 1, 2017 · Synced Sep 22, 2026

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