Yellow Fever Virus Vaccine and Immune Globulin Study

NCT00254826 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-12-04

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00254826 on ClinicalTrials.gov