Yellow Fever Virus Vaccine and Immune Globulin Study - Full Text View

Sponsor:	Emory University
Collaborators:	Sanofi Pasteur MSD Centers for Disease Control and Prevention
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00254826

Purpose

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.

Condition	Intervention	Phase
Viremia Immune Response to Yellow Fever Virus Vaccination	Biological: YF-VAX and Gama STAN S/D	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Randomized Controlled Double-Blind Trial of the Comparative Viremia, Immunogenicity and Safety of a 17-D Live Attenuated Yellow Fever Vaccine (YF-VAX)Given Alone or in Combination With Human Immune Globulin (GamaSTAN S/D)

Resource links provided by NLM:

MedlinePlus related topics: Fever

Drug Information available for: Immunoglobulins Yellow Fever Vaccine Globulin, Immune

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

Compare the proportion of participants developing viremia between the group receiving the yellow fever vaccine/saline and yellow fever vaccine with human immune globulin.
Characterize the dynamics of T cell activation, cytokine response and dendritic cell response in vaccinees during primary response to the yellow fever vaccine and yellow fever vaccine in combination with human immune globulin.
Compare the proportion of subjects in each group that seroconverts in the group of vaccinees without prior yellow fever immunity.

Secondary Outcome Measures:

Compare the viremia levels between the group of vaccinees receiving yellow fever vaccine with the group receiving yellow fever vaccine with human immune globulin.
Compare the dynamics of T cell activation, cytokine response and dendritic cell response in vaccinees during primary response to yellow fever vaccine to vaccinees given yellow fever vaccine given in combination with human immune globulin.
Compare the geometric mean neutralizing antibody titer in the group of yellow fever vaccinees with the group of vaccinees receiving yellow fever vaccine in combination with human immune globulin.

Estimated Enrollment:	80
Study Start Date:	June 2006
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

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Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254826

Locations

United States, Georgia
Emory Vaccine Center-The Hope Clinic and The Pediatric ID Clinic
Decatur, Georgia, United States, 30030

Sponsors and Collaborators

Emory University

Sanofi Pasteur MSD

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Carlos del Rio, MD

Emory University

More Information

Additional Information:

Emory Vaccine Center-The Hope Clinic This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00254826 History of Changes
Other Study ID Numbers:	085-2004
Study First Received:	November 15, 2005
Last Updated:	December 8, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emory University:

Yellow Fever Virus Vaccination

Additional relevant MeSH terms:

Fever
Viremia
Yellow Fever
Body Temperature Changes
Signs and Symptoms
Virus Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012