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Randomized, Double-blind, Placebo Controlled Phase II Trial of the Safety, Tolerability and Immunogenicity of Lyophilized ChimeriVax-WN02 West Nile Vaccine in Healthy Adults
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.
Details
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 208 |
| Start date | 2005-12 |
| Completion | 2009-04 |
Conditions
- West Nile Fever
Interventions
- ChimeriVax-WN02 Low Dose
- ChimeriVax-WN02 Medium Dose
- ChimeriVax-WN02 High Dose
- 0.9% Saline solution
- ChimeriVax-WN02 High Dose
- 0.9 % NaCl solution
Primary outcomes
- Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion). — Day 28 post-vaccination
Seroconversion was defined as a fourfold or greater rise in titer between pre- and post-immunization samples - Number of Viremic Participants Post-vaccination — Day 21 post-vaccination
Viremic = detectable level of ≥ 10 plaque-forming units (PFU)/mL - 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
Countries
United States