Clinical trial NCT00746798: Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults
Official title: Randomized, Modified, Double-blind, Placebo-controlled, Phase II, Dose-ranging Study of the Safety and Immunogenicity of Single Dose ChimeriVax-WN02 Vaccine in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: West Nile Fever
Keywords: West Nile Fever
ChimeriVax
West Nile Virus Vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 479
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine
timeFrame: Day 0 and Day 28 post-vaccination
measure: Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
timeFrame: Day 0 and Day 28 post-vaccination
measure: Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
timeFrame: Day 0 up to Day 14 post-vaccination
Secondary outcomes:
measure: Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
timeFrame: Day 2 up to Day 14 post-vaccination
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Inst.
state: California
city: Colorado Springs
country: United States
facility: Lynn Health Science Institute
state: Colorado
city: South Miami
country: United States
facility: Miami Research
state: Florida
city: Boise
country: United States
facility: Advanced Clinical Research- Idaho
state: Idaho
city: Idaho Falls
country: United States
facility: Idaho Falls Infectious diseases
state: Idaho
city: Lenexa
country: United States
facility: Johnson County Clinical Trials
state: Kansas
city: Overland Park
country: United States
facility: Vince & Associates
state: Kansas
city: Springfield
country: United States
facility: Bio-Kinetic
state: Missouri
city: Butte
country: United States
facility: Big Sky Clinical Research
state: Montana
city: Missoula
country: United States
facility: Infectious Disease Specialists, PC
state: Montana
city: Fargo
country: United States
facility: Odyssey Research
state: North Dakota
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Fort Worth
country: United States
facility: Benchmark
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research
state: Utah
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Director
role: STUDY_DIRECTOR
References: