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

Completed · Phase 2 · Has a placebo group

Conditions studied: West Nile Fever

In brief

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.

Key facts

Study ID

NCT00746798

Run by

Sanofi Pasteur, a Sanofi Company

People needed

479

Starts

2008-10-01

Expected to finish

2009-12-01

Last updated by the study team

2015-04-03

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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