Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults
WinVax004
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.
1 other identifier
interventional
479
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2008
Shorter than P25 for phase_2
15 active sites
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
September 2, 2008
CompletedFirst Posted
Study publicly available on registry
September 4, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
November 2, 2011
CompletedApril 3, 2015
March 1, 2015
8 months
September 2, 2008
September 27, 2011
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine
Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.
Day 0 and Day 28 post-vaccination
Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Antibodies to vaccine were measured by the Plaque Reduction Neutralization Test. Seroconversion was defined as a four-fold or greater rise in titer between pre- and post-injection samples; or a post-vaccination (Day 28) titers of ≥ 1:20 in participants with baseline titer ≤ 1:10.
Day 0 and Day 28 post-vaccination
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Day 0 up to Day 14 post-vaccination
Secondary Outcomes (1)
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Day 2 up to Day 14 post-vaccination
Study Arms (4)
ChimeriVax WN02 vaccine, low dose
EXPERIMENTALParticipants randomized to receive ChimeriVax WN02 vaccine, low dose
ChimeriVax-WN02 vaccine, medium dose
EXPERIMENTALParticipants randomized to receive ChimeriVax-WN02 vaccine, medium dose
ChimeriVax-WN02 vaccine, high dose
EXPERIMENTALParticipants randomized to receive ChimeriVax-WN02 vaccine, high dose
Placebo
PLACEBO COMPARATORParticipants randomized to receive Placebo (Saline)
Interventions
low dose, approximately 4 x 3log10, given one time subcutaneously
Eligibility Criteria
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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Advanced Clinical Research Inst.
Anaheim, California, 92801, United States
Lynn Health Science Institute
Colorado Springs, Colorado, 80909, United States
Miami Research
South Miami, Florida, 33143, United States
Advanced Clinical Research- Idaho
Boise, Idaho, 83642, United States
Idaho Falls Infectious diseases
Idaho Falls, Idaho, 83404, United States
Johnson County Clinical Trials
Lenexa, Kansas, 66219, United States
Vince & Associates
Overland Park, Kansas, 66211, United States
Bio-Kinetic
Springfield, Missouri, 65802, United States
Big Sky Clinical Research
Butte, Montana, 59701, United States
Infectious Disease Specialists, PC
Missoula, Montana, 59802, United States
Odyssey Research
Fargo, North Dakota, 88104, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Research Across America
Dallas, Texas, 75234, United States
Benchmark
Fort Worth, Texas, 76135, United States
Radiant Research
Salt Lake City, Utah, 84107, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2008
First Posted
September 4, 2008
Study Start
October 1, 2008
Primary Completion
June 1, 2009
Study Completion
December 1, 2009
Last Updated
April 3, 2015
Results First Posted
November 2, 2011
Record last verified: 2015-03