Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00442169

Purpose

The purpose of this study is to determine whether a single subcutaneous injection of ChimeriVax-WN02 vaccine is well tolerated, safe and induces protective antibodies against West Nile Disease. The study is divided into two parts; in the first part, a comparison of 3 dose levels of the vaccine will be made, with an inactive control. In the second part, the optimum dose level chosen after the first part will be given to older volunteers.

Condition	Intervention	Phase
West Nile Fever	Biological: ChimeriVax-WN02 Drug: Placebo	Phase II

MedlinePlus related topics: Fever West Nile Virus

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Double-Blind, Placebo Controlled Phase II Trial of the Safety, Tolerability and Immunogenicity of Lyophilized ChimeriVax-WN02 West Nile Vaccine in Healthy Adults

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Comparison of adverse event incidence rates between treatment groups (dose levels) and against placebo. [ Time Frame: 28 days following vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To measure adverse event incidence rates and viremia between each age group. [ Time Frame: 28 days following vaccination. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	208
Study Start Date:	December 2005
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Dose ranging in healthy adults between the ages of 18-40, against a placebo control.	Biological: ChimeriVax-WN02 Single dose formulation given in a volume of .5 mL by subcutaneous injection to the deltoid region. Drug: Placebo .9% Saline for injection
2: Active Comparator Dose level selected from part one in healthy subjects ages 41-64, against a placebo control.	Biological: ChimeriVax-WN02 Single dose formulation given in a volume of .5 mL by subcutaneous injection to the deltoid region. Drug: Placebo .9% Saline for injection
3: Active Comparator Dose level selected from part one in healthy subjects ages 65 and above, against a placebo control.	Biological: ChimeriVax-WN02 Single dose formulation given in a volume of .5 mL by subcutaneous injection to the deltoid region. Drug: Placebo .9% Saline for injection

Detailed Description:

West Nile Disease has been carried across the United States by migrating birds since it was first identified in New York city in 1999. It is transmitted by mosquitoes from birds to humans and can cause severe disease in some individuals. There is no specific treatment for West Nile Disease. The target population for a West Nile vaccine is older people, as they are more susceptible to severe disease. This trial includes a dose-finding part with a placebo control in young healthy adults, followed by a placebo-controlled examination of the chosen dose in older healthy adults.

Outcome measures include a comparison of adverse events between active treatment and placebo, a comparison of antibody and viremia measurements between dose levels and across age groups for the dose chosen for Part 2.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adult
Women of child-bearing potential should be using hormonal contraception.

Exclusion Criteria:

Previous vaccination against yellow fever or Japanese encephalitis
History of flavivirus infection
Any abnormalities of immune system, or using drugs that affect the immune system.
History of anaphylaxis to foods, bee stings, vaccines or drugs.
Receipt of blood or blood products within the preceding 6 months.
Receipt of any vaccine in the preceding 30 days
Seropositive to HCV, HBsAg or HIV
Lactation or intended pregnancy in female subjects
Previous or current military service with overseas deployment
Travel to Mexico or other flavivirus endemic areas in the tropics for periods of four weeks or more in the previous ten years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442169

Locations

United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
United States, Idaho
Idaho Infectious Diseases, PLLC
Idaho Falls, Idaho, United States, 83404
United States, Kansas
PRA International Clinical Pharmacology Center
Lenexa, Kansas, United States, 66219
United States, Missouri
Bio-Kinetic Clinical Applications, Inc.
Springfield, Missouri, United States, 65802
United States, Virginia
The Glennan Centre for Geriatrics and Gerontologyy, EVMS
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Michael Watson, MD

Sanofi-Aventis

More Information

Responsible Party:	Sanofi Pasteur Inc ( Medical Director )
Study ID Numbers:	H-244-003
Study First Received:	February 27, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00442169
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

West Nile Disease
Antibody response
Viremia

Safety
Tolerability
Prevention

Study placed in the following topic categories:

Virus Diseases
Fever
Antibodies
Central Nervous System Infections
West Nile Fever
Central Nervous System Diseases

Healthy
Arbovirus Infections
Viremia
Encephalitis
Immunoglobulins

Additional relevant MeSH terms:

Encephalitis, Viral
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections

Nervous System Diseases
Central Nervous System Viral Diseases
Encephalitis, Arbovirus

ClinicalTrials.gov processed this record on January 16, 2009