West Nile Fever
Conditions
Keywords
West Nile Disease, Antibody response, Viremia, Safety, Tolerability, Prevention
Brief summary
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.
Detailed description
West Nile Disease has been carried across the United States by migrating birds since it was first identified in New York city in 1999. It is transmitted by mosquitoes from birds to humans and can cause severe disease in some individuals. There is no specific treatment for West Nile Disease. The target population for a West Nile vaccine is older people, as they are more susceptible to severe disease. This trial includes a dose-finding part with a placebo control in young healthy adults, followed by a placebo-controlled examination of the chosen dose in older healthy adults. Outcome measures include a comparison of adverse events between active treatment and placebo, a comparison of antibody and viremia measurements between dose levels and across age groups for the dose chosen for Part 2.
Interventions
BIOLOGICALChimeriVax-WN02 Low Dose
Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region.
BIOLOGICALChimeriVax-WN02 Medium Dose
Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
BIOLOGICALChimeriVax-WN02 High Dose
Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
BIOLOGICAL0.9% Saline solution
Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
BIOLOGICAL0.9 % NaCl solution
Single dose given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
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
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Part 1 * Healthy adult aged 18 to 40 years. * Women of child-bearing potential should be using hormonal contraception. * Subject had to be available for the study duration, including all planned follow-up visits.
Exclusion criteria
Part 1 * Previous vaccination against yellow fever or Japanese encephalitis * History of flavivirus infection * Any abnormalities of immune system, or using drugs that affect the immune system. * History of anaphylaxis to foods, bee stings, vaccines or drugs. * Receipt of blood or blood products within the preceding 6 months. * Receipt of any vaccine in the preceding 30 days * Seropositive to hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV) * Lactation or intended pregnancy in female subjects * Previous or current military service with overseas deployment * Travel to Mexico or other flavivirus endemic areas in the tropics for periods of four weeks or more in the previous ten years. Inclusion Criteria: Part 2 * Aged ≥ 41 years. * Subjects had to be in general good health. * Unimpaired cognitive performance as assessed by clock drawing test score * Subject had to be available for all required study visits, including all planned follow-up visits. * Women of child-bearing potential should be using hormonal contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Days 0, 14, and 28 post-vaccination |
Other
| Measure | Time frame |
|---|---|
| Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | Days 14 and 28 post-vaccination |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 09 December 2005 to 27 March 2006 in 5 clinical centers in the US.
Pre-assignment details
A total of 208 participants (Part 1 = 112; Part 2 = 96) who met the inclusion and exclusion criteria were enrolled, randomized, and vaccinated in the study. Report on Part 1 and Part 2 participants with valid data are presented in this report.
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Part 1) Participants in Part 1 of the study who received a single dose of saline on Day 0 | 17 |
| WN02 Low Dose (Part 1) Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0 | 24 |
| WN02 Medium Dose (Part 1) Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0 | 40 |
| WN02 High Dose (Part 1) Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0 | 31 |
| Placebo (Part 2) Participants in Part 2 of the study who received a placebo vaccine on Day 0 | 25 |
| WNO2 High Dose (Part 2) Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0 | 57 |
| Total | 194 |
Baseline characteristics
| Characteristic | WN02 Low Dose (Part 1) | WN02 Medium Dose (Part 1) | WN02 High Dose (Part 1) | Placebo (Part 1) | Placebo (Part 2) | WNO2 High Dose (Part 2) | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 14 Participants | 28 Participants | 42 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 40 Participants | 31 Participants | 17 Participants | 11 Participants | 29 Participants | 152 Participants |
| Age, Continuous | 25.4 Years STANDARD_DEVIATION 5.62 | 25 Years STANDARD_DEVIATION 5.43 | 25.1 Years STANDARD_DEVIATION 6.47 | 26.6 Years STANDARD_DEVIATION 6.41 | 61.4 Years STANDARD_DEVIATION 11.8 | 61.0 Years STANDARD_DEVIATION 11.3 | 25.7 Years STANDARD_DEVIATION 6.13 |
| Region of Enrollment United States | 24 Participants | 40 Participants | 31 Participants | 17 Participants | 25 Participants | 57 Participants | 194 Participants |
| Sex: Female, Male Female | 12 Participants | 19 Participants | 13 Participants | 8 Participants | 22 Participants | 40 Participants | 114 Participants |
| Sex: Female, Male Male | 12 Participants | 21 Participants | 18 Participants | 9 Participants | 3 Participants | 17 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 17 | 16 / 24 | 28 / 40 | 22 / 31 | 25 / 32 | 54 / 64 |
| serious Total, serious adverse events | 0 / 17 | 0 / 24 | 0 / 40 | 1 / 31 | 0 / 32 | 3 / 64 |
Outcome results
Primary
Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion).
Seroconversion was defined as a fourfold or greater rise in titer between pre- and post-immunization samples
Time frame: Day 28 post-vaccination
Population: Seroconversion was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part 1) | Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion). | 0 Participants |
| WN02 Low Dose (Part 1) | Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion). | 21 Participants |
| WN02 Medium Dose (Part 1) | Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion). | 36 Participants |
| WN02 High Dose (Part 1) | Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion). | 27 Participants |
| Placebo (Part 2) | Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion). | 0 Participants |
| WNO2 High Dose (Part 2) | Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion). | 53 Participants |
Primary
Number of Viremic Participants Post-vaccination
Viremic = detectable level of ≥ 10 plaque-forming units (PFU)/mL
Time frame: Day 21 post-vaccination
Population: Viremia was assessed in all participants in the safety population according to the vaccine actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part 1) | Number of Viremic Participants Post-vaccination | 2 Participants |
| WN02 Low Dose (Part 1) | Number of Viremic Participants Post-vaccination | 22 Participants |
| WN02 Medium Dose (Part 1) | Number of Viremic Participants Post-vaccination | 36 Participants |
| WN02 High Dose (Part 1) | Number of Viremic Participants Post-vaccination | 29 Participants |
| Placebo (Part 2) | Number of Viremic Participants Post-vaccination | 1 Participants |
| WNO2 High Dose (Part 2) | Number of Viremic Participants Post-vaccination | 55 Participants |
Primary
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Time frame: Days 0 to 28 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants according to the vaccine actually received, safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Malaise | 2 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Diarrhoea | 0 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Headache | 5 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Feeling Hot | 0 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site induration | NA Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Pharyngolaryngeal pain | 2 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Myalgia | 3 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Somnolence | 1 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site pain | 2 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Dizziness | 0 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site erythema | NA Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Chills | 1 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Fatigue | 4 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Arthralgia | 0 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Musculoskeletal stiffness | 0 Participants |
| Placebo (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Nausea | 1 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Musculoskeletal stiffness | 1 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Chills | 1 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Myalgia | 1 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Malaise | 1 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Dizziness | 0 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Feeling Hot | 1 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site induration | NA Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Diarrhoea | 1 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Arthralgia | 1 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Somnolence | 1 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Headache | 4 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Pharyngolaryngeal pain | 0 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Nausea | 1 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site pain | 0 Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site erythema | NA Participants |
| WN02 Low Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Fatigue | 1 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Diarrhoea | 1 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site pain | 1 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site erythema | NA Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site induration | NA Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Musculoskeletal stiffness | 1 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Pharyngolaryngeal pain | 2 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Feeling Hot | 1 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Fatigue | 8 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Headache | 5 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Malaise | 3 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Myalgia | 3 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Arthralgia | 1 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Nausea | 2 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Somnolence | 2 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Chills | 1 Participants |
| WN02 Medium Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Dizziness | 1 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site pain | 0 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Headache | 2 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Dizziness | 0 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Arthralgia | 0 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Myalgia | 1 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Fatigue | 2 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Nausea | 1 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Pharyngolaryngeal pain | 1 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Somnolence | 1 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Musculoskeletal stiffness | 0 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site erythema | NA Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Diarrhoea | 0 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site induration | NA Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Chills | 1 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Malaise | 2 Participants |
| WN02 High Dose (Part 1) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Feeling Hot | 2 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Headache | 5 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Somnolence | 0 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Fatigue | 5 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Musculoskeletal stiffness | 5 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Myalgia | 5 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Arthralgia | 3 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Chills | 0 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Feeling Hot | 5 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Pharyngolaryngeal pain | 2 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Dizziness | 1 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Malaise | 3 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Nausea | 2 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Diarrhoea | 1 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site induration | 6 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site pain | 5 Participants |
| Placebo (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site erythema | 6 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site induration | 4 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Diarrhoea | 3 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site pain | 4 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Pharyngolaryngeal pain | 4 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Headache | 11 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Malaise | 10 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Feeling Hot | 11 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Myalgia | 13 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Arthralgia | 8 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Nausea | 5 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Somnolence | 5 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Chills | 4 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Dizziness | 2 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Musculoskeletal stiffness | 4 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Injection site erythema | 9 Participants |
| WNO2 High Dose (Part 2) | Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. | Fatigue | 11 Participants |
Secondary
Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination.
Time frame: Days 0, 14, and 28 post-vaccination
Population: Geometric mean titers were assessed according to the vaccine actually received, in the As treat per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo (Part 1) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 14 | 5.0 Titers |
| Placebo (Part 1) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 28 | 5.0 Titers |
| Placebo (Part 1) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 0 | 5.0 Titers |
| WN02 Low Dose (Part 1) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 0 | 5.0 Titers |
| WN02 Low Dose (Part 1) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 28 | 1367.3 Titers |
| WN02 Low Dose (Part 1) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 14 | 16.8 Titers |
| WN02 Medium Dose (Part 1) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 14 | 35.7 Titers |
| WN02 Medium Dose (Part 1) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 0 | 5.0 Titers |
| WN02 Medium Dose (Part 1) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 28 | 2331.1 Titers |
| WN02 High Dose (Part 1) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 14 | 26.9 Titers |
| WN02 High Dose (Part 1) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 0 | 5.0 Titers |
| WN02 High Dose (Part 1) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 28 | 3309.3 Titers |
| Placebo (Part 2) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 14 | 5.0 Titers |
| Placebo (Part 2) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 0 | 5.0 Titers |
| Placebo (Part 2) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 28 | 5.0 Titers |
| WNO2 High Dose (Part 2) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 0 | 5 Titers |
| WNO2 High Dose (Part 2) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 28 | 922.4 Titers |
| WNO2 High Dose (Part 2) | Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. | Day 14 | 19.2 Titers |
Other Pre-specified
Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population
Time frame: Days 14 and 28 post-vaccination
Population: Immunoglobulin M (IgM) response was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (Part 1) | Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | IgM Positive at Day 14 | 0 Participants |
| Placebo (Part 1) | Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | IgM Positive at Day 28 | 0 Participants |
| WN02 Low Dose (Part 1) | Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | IgM Positive at Day 14 | 5 Participants |
| WN02 Low Dose (Part 1) | Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | IgM Positive at Day 28 | 20 Participants |
| WN02 Medium Dose (Part 1) | Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | IgM Positive at Day 14 | 22 Participants |
| WN02 Medium Dose (Part 1) | Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | IgM Positive at Day 28 | 36 Participants |
| WN02 High Dose (Part 1) | Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | IgM Positive at Day 14 | 10 Participants |
| WN02 High Dose (Part 1) | Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | IgM Positive at Day 28 | 27 Participants |
| Placebo (Part 2) | Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | IgM Positive at Day 14 | 0 Participants |
| Placebo (Part 2) | Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | IgM Positive at Day 28 | 0 Participants |
| WNO2 High Dose (Part 2) | Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | IgM Positive at Day 14 | 26 Participants |
| WNO2 High Dose (Part 2) | Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population | IgM Positive at Day 28 | 53 Participants |