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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
479
low dose, approximately 4 x 3log10, given one time subcutaneously
medium dose, approximately 4 x 4log10, given one time
high dose, approximately 4 x 5log10, given one time subcutaneously
Advanced Clinical Research Inst.
Anaheim, California, United States
Lynn Health Science Institute
Colorado Springs, Colorado, United States
Miami Research
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0 up to Day 14 post-vaccination
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Viremia is defined as number of subjects in the analysis population dose group with detected (≥ 20 Plaque forming units \[pfu\]/mL) viremia at the reported visit.
Time frame: Day 2 up to Day 14 post-vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
0.9%Normal Saline for Injection, given one time subcutaneously
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
...and 5 more locations