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

Completed · Phase 1

Conditions studied: Healthy

In brief

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)

Key facts

Study ID

NCT00099463

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

10

Starts

2004-12-09

Expected to finish

2007-08-22

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• A volunteer will be excluded if one or more of the following conditions apply:
• Women:
• Woman who is breast-feeding or planning to become pregnant during the 32 weeks of study participation.
• Volunteer has received any of the following substances:
• Immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis).
• Blood products within 120 days prior to HIV screening.
• Immunoglobulin within 60 days prior to HIV screening.
• Investigational research agents within 30 days prior to initial study vaccine administration.
• Live attenuated vaccines within 30 days prior to initial study vaccine administration.
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration.
• Current anti-TB prophylaxis or therapy.
• Volunteer has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.
• Autoimmune disease or immunodeficiency.
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.
• Diabetes mellitus (type I or II), with the exception of gestational diabetes.
• History of thyroidectomy or thyroid disease that required medication within the past 12 months.
• Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.
• Hypertension that is not well controlled by medication or is more than 145/95 at enrollment.
• Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
• Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study.
• Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years.
• Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen.
• Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment.
• Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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