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 (Gama STAN S/D)

NCT00254826 Phase 1 COMPLETED

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.

Details

Lead sponsor	Emory University
Phase	Phase 1
Status	COMPLETED
Enrolment	80
Start date	2006-06
Completion	2008-11

Conditions

• Viremia

Interventions

• YF-VAX® plus saline
• 17D YF Vaccine plus Ig,

Primary outcomes

• Compare the proportion of participants developing viremia between the group receiving the yellow fever vaccine/saline and yellow fever vaccine with human immune globulin. — 91 Days

Countries

United States