Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults
Randomized, Double-blind, Placebo Controlled Phase II Trial of the Safety, Tolerability and Immunogenicity of Lyophilized ChimeriVax-WN02 West Nile Vaccine in Healthy Adults
1 other identifier
interventional
208
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2005
Typical duration for phase_2
5 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
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
February 14, 2011
CompletedApril 14, 2016
April 1, 2016
2.5 years
February 27, 2007
January 21, 2011
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion).
Seroconversion was defined as a fourfold or greater rise in titer between pre- and post-immunization samples
Day 28 post-vaccination
Number of Viremic Participants Post-vaccination
Viremic = detectable level of ≥ 10 plaque-forming units (PFU)/mL
Day 21 post-vaccination
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Days 0 to 28 post-vaccination
Secondary Outcomes (1)
Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination.
Days 0, 14, and 28 post-vaccination
Other Outcomes (1)
Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population
Days 14 and 28 post-vaccination
Study Arms (6)
Group 1: WN02 Low Dose (Part 1)
EXPERIMENTALLow Dose in healthy adults in Part 1 against a placebo control.
Group 2: WN02 Medium Dose (Part 1)
EXPERIMENTALMedium dose level in part one healthy subjects against a placebo control.
Group 3: WN02 High Dose (Part 1)
EXPERIMENTALHigh dose level in part one healthy subjects against a placebo control
Group 4: Placebo (Part 1)
PLACEBO COMPARATORParticipants will receive a single dose of saline in Part 1 on Day 0
Group 5: WNO2 High Dose (Part 2)
EXPERIMENTALParticipants enrolled in Part 2 and received a single dose of West Nile Virus vaccine.
Group 6: Placebo (part 2)
PLACEBO COMPARATORParticipants will receive a single dose of saline in Part 2 on Day 0
Interventions
Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region.
Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
Single dose given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
Eligibility Criteria
You may qualify if:
- Healthy adult aged 18 to 40 years.
- Women of child-bearing potential should be using hormonal contraception.
- Subject had to be available for the study duration, including all planned follow-up visits.
You may not qualify if:
- 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 hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (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.
- Aged ≥ 41 years.
- Subjects had to be in general good health.
- Unimpaired cognitive performance as assessed by clock drawing test score
- Subject had to be available for all required study visits, including all planned follow-up visits.
- Women of child-bearing potential should be using hormonal contraception.
- +47 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Idaho Infectious Diseases, PLLC
Idaho Falls, Idaho, 83404, United States
PRA International Clinical Pharmacology Center
Lenexa, Kansas, 66219, United States
Bio-Kinetic Clinical Applications, Inc.
Springfield, Missouri, 65802, United States
The Glennan Centre for Geriatrics and Gerontologyy, EVMS
Norfolk, Virginia, 23507, United States
Related Publications (1)
Biedenbender R, Bevilacqua J, Gregg AM, Watson M, Dayan G. Phase II, randomized, double-blind, placebo-controlled, multicenter study to investigate the immunogenicity and safety of a West Nile virus vaccine in healthy adults. J Infect Dis. 2011 Jan 1;203(1):75-84. doi: 10.1093/infdis/jiq003.
PMID: 21148499DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
February 27, 2007
First Posted
March 1, 2007
Study Start
December 1, 2005
Primary Completion
June 1, 2008
Study Completion
April 1, 2009
Last Updated
April 14, 2016
Results First Posted
February 14, 2011
Record last verified: 2016-04