Yellow Fever Virus Vaccine and Immune Globulin Study
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.
Immune Response to Yellow Fever Virus Vaccination
Biological: YF-VAX and Gama STAN S/D
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
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)|
- 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.
- 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.
|Study Start Date:||June 2006|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
|United States, Georgia|
|Emory Vaccine Center-The Hope Clinic and The Pediatric ID Clinic|
|Decatur, Georgia, United States, 30030|
|Principal Investigator:||Carlos del Rio, MD||Emory University|