West Nile Fever
Conditions
Keywords
West Nile Fever, ChimeriVax, West Nile Virus Vaccine
Brief 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.
Detailed description
Currently, the only method of prevention of West Nile infection is control of the mosquito vectors associated or avoidance of mosquito bites, which has proven largely ineffective. Developing a safe, effective vaccine and making it widely available will enhance the prospects of prevention and control of this disease. In addition, natural infections with the YF virus and WN virus are more severe in the elderly. Therefore, a study among healthy older subjects or those with well controlled chronic diseases will provide data to determine a ChimeriVax-WN02 vaccine dose that is immunogenic and well tolerated.
Interventions
BIOLOGICALChimeriVax-WN02 vaccine
low dose, approximately 4 x 3log10, given one time subcutaneously
BIOLOGICALPlacebo
0.9%Normal Saline for Injection, given one time subcutaneously
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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 disease or injury including but not limited to: Parkinson's, Guillain Barré, epilepsy, seizures (except febrile seizures under the age of 2), cerebrovascular accident, head trauma requiring hospitalization within the preceding 3 years, or any other neurologic condition thought to impact the integrity of the blood brain barrier. * Clinically significant abnormal ECG findings at Screening * Impaired hepatic function, and/or clinically significant or unexplained elevations of alanine aminotransferase (ALT, SGPT), or aspartate aminotransferase (AST, SGOT) \> 3X the upper limit of normal. * Impaired renal function, as shown by but not limited to, serum creatinine \>2.0 mg/dL. * Impaired hematopoietic function and/or clinically significant hematological laboratory abnormalities. * A history of alcohol or drug abuse within 12 months prior to study entry. * Pregnant or lactating women and women of childbearing potential who are not using an acceptable method of contraception at least 28 days prior to enrollment. Post menopausal women will be considered not of childbearing potential 1 year after last menstrual period. * Behavioral, cognitive, or psychiatric disease that, in the opinion of the Investigator affects the ability of the subject to understand the scope of the study and/or unlikely to be able to be compliant with the study procedures and visits. * Any other condition, which in the Investigator's judgment, might result in an increased risk to the subject, or would affect the subject's participation in the study. * Participation in another clinical trial investigating a vaccine, drug or medical procedure in the 30 days preceding informed consent. * Any vaccine administered within 30 days prior to study vaccination. Note: Influenza vaccine can be administered 1 week preceding study vaccination. * Planned participation in another clinical trial during the present trial period. * Planned receipt of any vaccine in the 4 weeks following the trial vaccination. * Research site personnel or their family members cannot be enrolled as subjects in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine | Day 0 and Day 28 post-vaccination | Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test. |
| Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 0 and Day 28 post-vaccination | 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. |
| Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 0 up to Day 14 post-vaccination | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 2 up to Day 14 post-vaccination | Viremia is defined as number of subjects in the analysis population dose group with detected (≥ 20 Plaque forming units \[pfu\]/mL) viremia at the reported visit. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 03 October 2008 to 08 December 2008 in 15 clinical centers in the US.
Pre-assignment details
A total of 498 of the 479 randomized participants who met the inclusion and exclusion criteria were vaccinated. 1 subject was withdrawn from the study before receiving any study vaccine and was excluded from analysis and this report.
Participants by arm
| Arm | Count |
|---|---|
| ChimeriVax WN02 Vaccine Low Dose Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously | 122 |
| ChimeriVax WN02 Vaccine Medium Dose Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously | 124 |
| ChimeriVax WN02 Vaccine High Dose Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously | 113 |
| Placebo Participants who received placebo (saline) given one time subcutaneously | 120 |
| Total | 479 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 2 | 0 |
| Overall Study | Participant unable to return for visit | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | ChimeriVax WN02 Vaccine Medium Dose | ChimeriVax WN02 Vaccine High Dose | ChimeriVax WN02 Vaccine Low Dose | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 49 Participants | 51 Participants | 50 Participants | 44 Participants | 194 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants | 62 Participants | 72 Participants | 76 Participants | 285 Participants |
| Age, Continuous | 62.9 Years STANDARD_DEVIATION 8.1 | 63.4 Years STANDARD_DEVIATION 9.01 | 63.1 Years STANDARD_DEVIATION 9.39 | 62.2 Years STANDARD_DEVIATION 8.28 | 62.9 Years STANDARD_DEVIATION 8.69 |
| Region of Enrollment United States | 124 Participants | 113 Participants | 122 Participants | 120 Participants | 479 Participants |
| Sex: Female, Male Female | 65 Participants | 63 Participants | 76 Participants | 64 Participants | 268 Participants |
| Sex: Female, Male Male | 59 Participants | 50 Participants | 46 Participants | 56 Participants | 211 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 51 / 122 | 56 / 124 | 42 / 112 | 54 / 120 |
| serious Total, serious adverse events | 4 / 122 | 1 / 124 | 3 / 112 | 5 / 120 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine
Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.
Time frame: Day 0 and Day 28 post-vaccination
Population: Serum antibody levels were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ChimeriVax WN02 Vaccine Low Dose | Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine | Day 28 | 688 Titers |
| ChimeriVax WN02 Vaccine Low Dose | Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine | Day 0 | 5.00 Titers |
| ChimeriVax WN02 Vaccine Medium Dose | Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine | Day 0 | 5.76 Titers |
| ChimeriVax WN02 Vaccine Medium Dose | Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine | Day 28 | 600 Titers |
| ChimeriVax WN02 Vaccine High Dose | Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine | Day 28 | 674 Titers |
| ChimeriVax WN02 Vaccine High Dose | Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine | Day 0 | 5.06 Titers |
| Placebo | Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine | Day 28 | 5.93 Titers |
| Placebo | Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine | Day 0 | 5.22 Titers |
Primary
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Time frame: Day 0 up to Day 14 post-vaccination
Population: Safety assessments were on the Safety, intend-to-treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Fever (≥ 39.0 ºC or ≥ 102.1 ºF) | 0 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Erythema [N = 122, 123, 112, 120] | 2 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Myalgia [N = 122, 123, 112, 120] | 28 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Swelling [N = 121, 123, 112, 120] | 1 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Myalgia (Prevents daily activities) | 2 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Pain (Prevents daily activities) | 0 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Headache (prevents daily activities) | 2 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Swelling (> 10 cm) | 0 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Malaise [N = 122, 123, 112, 120] | 26 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Pain [N = 122, 123, 112, 120] | 14 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Malaise (Prevents daily activities) | 2 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Fever [N = 122, 123, 111, 120] | 0 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Headache [N = 122, 123, 112, 120] | 31 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Erythema (> 10 cm) | 0 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Pain [N = 122, 123, 112, 120] | 29 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Fever (≥ 39.0 ºC or ≥ 102.1 ºF) | 0 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Headache [N = 122, 123, 112, 120] | 34 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Headache (prevents daily activities) | 3 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Erythema [N = 122, 123, 112, 120] | 4 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Myalgia [N = 122, 123, 112, 120] | 25 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Erythema (> 10 cm) | 0 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Myalgia (Prevents daily activities) | 2 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Swelling [N = 121, 123, 112, 120] | 0 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Malaise (Prevents daily activities) | 4 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Swelling (> 10 cm) | 0 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Pain (Prevents daily activities) | 1 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Fever [N = 122, 123, 111, 120] | 0 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Malaise [N = 122, 123, 112, 120] | 26 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Myalgia (Prevents daily activities) | 1 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Pain [N = 122, 123, 112, 120] | 10 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Pain (Prevents daily activities) | 0 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Erythema [N = 122, 123, 112, 120] | 0 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Erythema (> 10 cm) | 0 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Swelling [N = 121, 123, 112, 120] | 0 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Swelling (> 10 cm) | 0 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Fever [N = 122, 123, 111, 120] | 3 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Fever (≥ 39.0 ºC or ≥ 102.1 ºF) | 1 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Headache [N = 122, 123, 112, 120] | 33 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Headache (prevents daily activities) | 3 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Malaise [N = 122, 123, 112, 120] | 27 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Malaise (Prevents daily activities) | 3 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Myalgia [N = 122, 123, 112, 120] | 22 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Fever [N = 122, 123, 111, 120] | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Pain (Prevents daily activities) | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Malaise [N = 122, 123, 112, 120] | 25 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Swelling (> 10 cm) | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Swelling [N = 121, 123, 112, 120] | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Pain [N = 122, 123, 112, 120] | 12 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Malaise (Prevents daily activities) | 2 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Erythema (> 10 cm) | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Erythema [N = 122, 123, 112, 120] | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Headache [N = 122, 123, 112, 120] | 31 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Any Myalgia [N = 122, 123, 112, 120] | 20 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Headache (prevents daily activities) | 1 Participants |
| Placebo | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Grade 3 Fever (≥ 39.0 ºC or ≥ 102.1 ºF) | 0 Participants |
Primary
Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
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.
Time frame: Day 0 and Day 28 post-vaccination
Population: Serum antibody levels and seroconversion were assessed in the per-protocol population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | 105 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | 110 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | 103 Participants |
| Placebo | Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | 3 Participants |
Secondary
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Viremia is defined as number of subjects in the analysis population dose group with detected (≥ 20 Plaque forming units \[pfu\]/mL) viremia at the reported visit.
Time frame: Day 2 up to Day 14 post-vaccination
Population: Viremia concentrations were assessed in a randomly selected subset of the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 2 | 1 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 12 | 7 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 10 | 15 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 4 | 33 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 14 | 2 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 6 | 21 Participants |
| ChimeriVax WN02 Vaccine Low Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 8 | 19 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 12 | 5 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 8 | 19 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 6 | 33 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 10 | 18 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 14 | 0 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 4 | 28 Participants |
| ChimeriVax WN02 Vaccine Medium Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 2 | 0 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 8 | 21 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 2 | 1 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 4 | 15 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 6 | 29 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 10 | 8 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 12 | 7 Participants |
| ChimeriVax WN02 Vaccine High Dose | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 14 | 2 Participants |
| Placebo | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 6 | 0 Participants |
| Placebo | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 14 | 0 Participants |
| Placebo | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 12 | 0 Participants |
| Placebo | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 4 | 0 Participants |
| Placebo | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 2 | 0 Participants |
| Placebo | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 10 | 1 Participants |
| Placebo | Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Day 8 | 0 Participants |