NCT00254826

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2005

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

2.4 years

First QC Date

November 15, 2005

Last Update Submit

December 3, 2013

Conditions

Viremia

Keywords

Yellow Fever Virus Vaccination

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Compare the viremia levels between the group of vaccinees receiving yellow fever vaccine with the group receiving yellow fever vaccine with human immune globulin.

    91 days

  • 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.

    91 days

  • 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.

    91 days

Study Arms (2)

YF-VAX® plus saline

OTHER

Drug: YF-VAX® plus saline

Biological: YF-VAX® plus saline

17D YF Vaccine plus Ig

EXPERIMENTAL

Drug: 17D YF Vaccine plus Ig; one vaccine on day 0

Biological: 17D YF Vaccine plus Ig,

Interventions

YF-VAX® plus salineBIOLOGICAL

YF-VAX® plus saine

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

17D YF Vaccine plus Ig, one vaccine on day 0

17D YF Vaccine plus Ig

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Vaccine Center-The Hope Clinic and The Pediatric ID Clinic

Decatur, Georgia, 30030, United States

Location

Related Publications (1)

  • Edupuganti S, Eidex RB, Keyserling H, Akondy RS, Lanciotti R, Orenstein W, del Rio C, Pan Y, Querec T, Lipman H, Barrett A, Ahmed R, Teuwen D, Cetron M, Mulligan MJ; YF-Ig Study Team. A randomized, double-blind, controlled trial of the 17D yellow fever virus vaccine given in combination with immune globulin or placebo: comparative viremia and immunogenicity. Am J Trop Med Hyg. 2013 Jan;88(1):172-7. doi: 10.4269/ajtmh.2012.12-0179. Epub 2012 Dec 3.

    PMID: 23208880DERIVED

Related Links

MeSH Terms

Conditions

Viremia

Interventions

Yellow Fever VaccineSodium Chloride

Condition Hierarchy (Ancestors)

Virus DiseasesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mark J. Mulligan, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 17, 2005

Study Start

June 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

US(1)