Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00746798 | Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults | PHASE2 | COMPLETED | 479 | — | — | Oct 1, 2008 | Dec 1, 2009 | Apr 3, 2015 | 15 | United States |
| NCT00442169 | Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults | PHASE2 | COMPLETED | 208 | — | — | Dec 1, 2005 | Apr 1, 2009 | Apr 14, 2016 | 5 | United States |
Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.
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.
Seroconversion was defined as a fourfold or greater rise in titer between pre- and post-immunization samples
Viremic = detectable level of ≥ 10 plaque-forming units (PFU)/mL
| Arm | Type | Description |
|---|---|---|
| ChimeriVax WN02 vaccine, low dose | EXPERIMENTAL | Participants randomized to receive ChimeriVax WN02 vaccine, low dose |
| ChimeriVax-WN02 vaccine, medium dose | EXPERIMENTAL | Participants randomized to receive ChimeriVax-WN02 vaccine, medium dose |
| ChimeriVax-WN02 vaccine, high dose | EXPERIMENTAL | Participants randomized to receive ChimeriVax-WN02 vaccine, high dose |
| Placebo | PLACEBO_COMPARATOR | Participants randomized to receive Placebo (Saline) |
| Group 1: WN02 Low Dose (Part 1) | EXPERIMENTAL | Low Dose in healthy adults in Part 1 against a placebo control. |
| Group 2: WN02 Medium Dose (Part 1) | EXPERIMENTAL | Medium dose level in part one healthy subjects against a placebo control. |
| Group 3: WN02 High Dose (Part 1) | EXPERIMENTAL | High dose level in part one healthy subjects against a placebo control |
| Group 4: Placebo (Part 1) | PLACEBO_COMPARATOR | Participants will receive a single dose of saline in Part 1 on Day 0 |
| Group 5: WNO2 High Dose (Part 2) | EXPERIMENTAL | Participants enrolled in Part 2 and received a single dose of West Nile Virus vaccine. |
| Group 6: Placebo (part 2) | PLACEBO_COMPARATOR | Participants will receive a single dose of saline in Part 2 on Day 0 |
| Name | Type | Description |
|---|---|---|
| ChimeriVax-WN02 vaccine | BIOLOGICAL | low dose, approximately 4 x 3log10, given one time subcutaneously |
| Placebo | BIOLOGICAL | 0.9%Normal Saline for Injection, given one time subcutaneously |
| ChimeriVax-WN02 Low Dose | BIOLOGICAL | Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region. |
| ChimeriVax-WN02 Medium Dose | BIOLOGICAL | Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region |
| ChimeriVax-WN02 High Dose | BIOLOGICAL | Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region |
| 0.9% Saline solution | BIOLOGICAL | Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region |
| 0.9 % NaCl solution | BIOLOGICAL | Single dose given in a volume of 0.5 mL by subcutaneous injection to the deltoid region |
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: * ...