Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults

NCT ID: NCT00746798

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 479 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-12-31

Brief Summary

The purpose of this study is to determine if ChimeriVax West Nile vaccine is safe and effective in preventing West Nile disease in adults over 50 years of age.

Detailed Description

Currently, the only method of prevention of West Nile infection is control of the mosquito vectors associated or avoidance of mosquito bites, which has proven largely ineffective. Developing a safe, effective vaccine and making it widely available will enhance the prospects of prevention and control of this disease. In addition, natural infections with the YF virus and WN virus are more severe in the elderly. Therefore, a study among healthy older subjects or those with well controlled chronic diseases will provide data to determine a ChimeriVax-WN02 vaccine dose that is immunogenic and well tolerated.

Conditions

West Nile Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

ChimeriVax WN02 vaccine, low dose

Participants randomized to receive ChimeriVax WN02 vaccine, low dose

Group Type: EXPERIMENTAL

ChimeriVax-WN02 vaccine

Intervention Type: BIOLOGICAL

low dose, approximately 4 x 3log10, given one time subcutaneously

ChimeriVax-WN02 vaccine, medium dose

Participants randomized to receive ChimeriVax-WN02 vaccine, medium dose

Group Type: EXPERIMENTAL

ChimeriVax-WN02 vaccine

Intervention Type: BIOLOGICAL

medium dose, approximately 4 x 4log10, given one time

ChimeriVax-WN02 vaccine, high dose

Participants randomized to receive ChimeriVax-WN02 vaccine, high dose

Group Type: EXPERIMENTAL

ChimeriVax-WN02 vaccine

Intervention Type: BIOLOGICAL

high dose, approximately 4 x 5log10, given one time subcutaneously

Placebo

Participants randomized to receive Placebo (Saline)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

0.9%Normal Saline for Injection, given one time subcutaneously

Interventions

ChimeriVax-WN02 vaccine

low dose, approximately 4 x 3log10, given one time subcutaneously

Intervention Type: BIOLOGICAL

ChimeriVax-WN02 vaccine

medium dose, approximately 4 x 4log10, given one time

Intervention Type: BIOLOGICAL

ChimeriVax-WN02 vaccine

high dose, approximately 4 x 5log10, given one time subcutaneously

Intervention Type: BIOLOGICAL

Placebo

0.9%Normal Saline for Injection, given one time subcutaneously

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Medically stable, ambulatory male or female ≥ 50 years of age.
• Attend all scheduled visits and to comply with all study procedures.
• Negative serum pregnancy test at Screening, and a negative urine pregnancy test on Day 0.

Exclusion Criteria

• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg of prednisone or equivalent), or depot preparation within the previous 3 months. Topical steroids are allowed.
• Administration of immunoglobulins and/or any blood products within 3 months before enrollment or planned administration during treatment period of study.
• Presence of acute or chronic illness associated with an oral temperature of >38.0 °C or requiring hospitalization at time of enrollment.
• Any of the following serological findings at Screening:

positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C (anti-HCV), or positive human immunodeficiency virus (HIV).

• Personal or family history of thymic pathology (e.g., thymoma), thymectomy, or myasthenia.
• History of significant allergic reaction to the vaccine components
• Asplenia, functional asplenia, or any condition resulting in the absence or removal of the spleen.
• Active or potentially progressive neurologic disease or injury including but not limited to: Parkinson's, Guillain Barré, epilepsy, seizures (except febrile seizures under the age of 2), cerebrovascular accident, head trauma requiring hospitalization within the preceding 3 years, or any other neurologic condition thought to impact the integrity of the blood brain barrier.
• Clinically significant abnormal ECG findings at Screening
• Impaired hepatic function, and/or clinically significant or unexplained elevations of alanine aminotransferase (ALT, SGPT), or aspartate aminotransferase (AST, SGOT) > 3X the upper limit of normal.
• Impaired renal function, as shown by but not limited to, serum creatinine >2.0 mg/dL.
• Impaired hematopoietic function and/or clinically significant hematological laboratory abnormalities.
• A history of alcohol or drug abuse within 12 months prior to study entry.
• Pregnant or lactating women and women of childbearing potential who are not using an acceptable method of contraception at least 28 days prior to enrollment. Post menopausal women will be considered not of childbearing potential 1 year after last menstrual period.
• Behavioral, cognitive, or psychiatric disease that, in the opinion of the Investigator affects the ability of the subject to understand the scope of the study and/or unlikely to be able to be compliant with the study procedures and visits.
• Any other condition, which in the Investigator's judgment, might result in an increased risk to the subject, or would affect the subject's participation in the study.
• Participation in another clinical trial investigating a vaccine, drug or medical procedure in the 30 days preceding informed consent.
• Any vaccine administered within 30 days prior to study vaccination. Note: Influenza vaccine can be administered 1 week preceding study vaccination.
• Planned participation in another clinical trial during the present trial period.
• Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
• Research site personnel or their family members cannot be enrolled as subjects in this trial.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc

Locations

Advanced Clinical Research Inst.

Anaheim, California, United States

Lynn Health Science Institute

Colorado Springs, Colorado, United States

Miami Research

South Miami, Florida, United States

Advanced Clinical Research- Idaho

Boise, Idaho, United States

Idaho Falls Infectious diseases

Idaho Falls, Idaho, United States

Johnson County Clinical Trials

Lenexa, Kansas, United States

Vince & Associates

Overland Park, Kansas, United States

Bio-Kinetic

Springfield, Missouri, United States

Big Sky Clinical Research

Butte, Montana, United States

Infectious Disease Specialists, PC

Missoula, Montana, United States

Odyssey Research

Fargo, North Dakota, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Research Across America

Dallas, Texas, United States

Benchmark

Fort Worth, Texas, United States

Radiant Research

Salt Lake City, Utah, United States

Countries

United States

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

H-244-004

Identifier Type: -

Identifier Source: org_study_id