Yellow Fever Virus Vaccine and Immune Globulin Study
NCT00254826 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2013-12-04
Summary
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.
Conditions
- Viremia
Interventions
- BIOLOGICAL
-
YF-VAX® plus saline
YF-VAX® plus saine
- BIOLOGICAL
-
17D YF Vaccine plus Ig,
17D YF Vaccine plus Ig, one vaccine on day 0
Sponsors & Collaborators
-
Sanofi Pasteur, a Sanofi Company
collaborator INDUSTRY -
Centers for Disease Control and Prevention
collaborator FED -
Emory University
lead OTHER
Principal Investigators
-
Mark J. Mulligan, MD · Emory University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-06-30
- Primary Completion
- 2008-11-30
- Completion
- 2008-11-30
Countries
- United States
Study Locations
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