Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults (NCT00746798) | Clinical Trial Compass
CompletedPhase 2
Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults
United States479 participantsStarted 2008-10
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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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 di…
What they're measuring
1
Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVaxâ„¢ WN02 or a Placebo Vaccine
Timeframe: Day 0 and Day 28 post-vaccination
2
Number of Participants With Seroconversion Following Vaccination With ChimeriVaxâ„¢ WN02 or a Placebo Vaccine.
Timeframe: Day 0 and Day 28 post-vaccination
3
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVaxâ„¢ WN02 or a Placebo Vaccine.