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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 for West Nile Fever, a mosquito-borne infectious disease. It is currently in Phase 2 clinical development and has not been approved by the FDA. The vaccine is designed to prevent infection caused by the West Nile virus.
ChimeriVax-WN02 vaccine is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine for West Nile Fever.
ChimeriVax-WN02 vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 2 clinical trials have been completed, both evaluating the vaccine's safety and immunogenicity in healthy adults.
ChimeriVax-WN02 vaccine has completed two Phase 2 clinical trials. The first, NCT00442169, enrolled 208 healthy adults aged 18 years and older in the United States. The second, NCT00746798, enrolled 479 healthy adults aged 50 years and older in the United States. Both trials were randomized, double-blind, and placebo-controlled.
ChimeriVax-WN02 vaccine is also referred to as ChimeriVax West Nile vaccine in clinical trial records. The two names refer to the same investigational vaccine being developed by Sanofi for West Nile Fever. Both Phase 2 trials used this vaccine candidate.