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Also known as ChimeriVax-WN02 Low Dose
ChimeriVax-WN02 vaccine · 2 trials · 1 indication
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: * ...
ChimeriVax-WN02 vaccine is an investigational vaccine being developed to prevent West Nile Fever, an infectious disease. It is a Phase 2 candidate developed by Sanofi, which trades under the ticker SNY. The vaccine has been studied in two completed clinical trials that together enrolled 687 participants.
ChimeriVax-WN02 vaccine is intended for the prevention of West Nile Fever. It is being evaluated in healthy adult volunteers rather than in patients already infected. Both completed Phase 2 trials listed West Nile Fever as the condition under study, and the program has not reported an approved indication.
ChimeriVax-WN02 vaccine is developed by Sanofi, the French pharmaceutical company whose shares trade on the New York Stock Exchange under the ticker SNY. Sanofi sponsored both Phase 2 trials of the vaccine, which were conducted in the United States.
ChimeriVax-WN02 vaccine is in Phase 2 development. Two Phase 2 trials have been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA for any use.
ChimeriVax-WN02 vaccine has been studied in two completed Phase 2 trials. NCT00442169 enrolled 208 healthy adults aged 18 and older, and NCT00746798 enrolled 479 healthy adults aged 50 and older. Both were randomized, double-blind, placebo-controlled safety and immunogenicity studies conducted in the United States.
Yes. ChimeriVax-WN02 Low Dose is an alternative name for ChimeriVax-WN02 vaccine, so searches for either term refer to the same Sanofi West Nile Fever vaccine candidate. Both names describe the same Phase 2 program studied in the two completed trials.