Yellow Fever Virus Vaccine and Immune Globulin Study

Completed · Phase 1

Conditions studied: Viremia

In brief

The purpose of this study is to determine whether immune globulin can limit the amount of yellow fever vaccine virus present in the blood after vaccination without compromising the immunity associated with the yellow fever vaccine. The study will enroll 80 participants in two groups of 40 each. The first group will receive the yellow fever vaccine with salt-water placebo. The second group will receive yellow fever vaccine with immune globulin. The amount of vaccine virus and immune response in both groups will be compared. Yellow fever vaccine has been used to protect humans against Yellow Fever Vaccine disease since the 1930s.

Key facts

Study ID

NCT00254826

Run by

Emory University

People needed

80

Starts

2006-06-01

Expected to finish

2008-11-01

Last updated by the study team

2013-12-04

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to understand and give informed consent
• Age 18-40 years old
• No medical contraindications to participation discovered at the screening visit
• Negative serologic test for HIV, HCV and Hepatitis B surface antigen at the screening visit
• Female volunteers of childbearing potential must agree to use effective birth control throughout the duration of the study. A negative urine pregnancy test must be documented prior to any injection.
• Must weigh at least 110 lbs

You may not qualify if…

• Any history of allergy or history of anaphylaxis to any of the vaccine components
• Any history of allergic reaction to human immune globulin or a history of IgA deficiency
• History of hypersensitivity to ingestion of eggs or allergic reaction to vaccines prepared in eggs or chick embryo cell cultures (e.g. influenza, measles)
• Known or suspected immunodeficiency (e.g. HIV infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (corticosteroids> 10 mg prednisolone/prednisone, or equivalent, for mare than 14 days in the last three months). Persons with previous skin cancer or cured non-lymphatic tumors are not excluded from the study.
• Any clinically significant chronic medical condition that is considered progressive including: hypertension, diabetes, gastrointestinal abnormalities (e.g. active peptic ulcer disease), cardiac, pulmonary, hepatic, renal, or neurologic disease.
• History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions, or occupational requirements that in the opinion of the investigator would preclude compliance with the trial
• Receipt of any live or inactivated vaccine between the screening visit and the day 0 visit, or any vaccine within 30 days of a vaccination visit
• Any subject found to be HIV positive, hepatitis B surface antigen positive, or hepatitis C antibody positive at the time of screening
• Any contraindication to intramuscular injection
• Women who are pregnant, nursing or expect to become pregnant during the study period
• Administration of a blood product or immune globulin product within 6 months of injection
• History of previous yellow fever, West Nile, dengue, St. Louis encephalitis, Japanese encephalitis or tick-borne encephalitis vaccination or infection
• Serologic evidence of previous yellow fever, West Nile, dengue, St. Louis encephalitis, Japanese encephalitis or tick-borne encephalitis vaccination or infection
• History of travel to a yellow fever endemic zone as defined by the Centers for Disease Control and Prevention. Health Information for International Travel, 2005-2006
• History of thymus disorder or dysfunction, including myasthenia gravis, thymoma, thymectomy, or DiGeorge syndrome
• History of an autoimmune disorder

Where it is running

• Emory Vaccine Center-The Hope Clinic and The Pediatric ID Clinic — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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