Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChimeriVax-WN02 vaccine | Biological | low dose, approximately 4 x 3log10, given one time subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 and Day 28 post-vaccination |
| 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. | Day 0 and Day 28 post-vaccination |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 2 up to Day 14 post-vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C (anti-HCV), or positive human immunodeficiency virus (HIV).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Inst. | Anaheim | California | 92801 | United States | ||
| Lynn Health Science Institute |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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 were enrolled from 03 October 2008 to 08 December 2008 in 15 clinical centers in the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | ChimeriVax WN02 Vaccine Medium Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ChimeriVax-WN02 vaccine | Biological | medium dose, approximately 4 x 4log10, given one time |
|
| ChimeriVax-WN02 vaccine | Biological | high dose, approximately 4 x 5log10, given one time subcutaneously |
|
| Placebo | Biological | 0.9%Normal Saline for Injection, given one time subcutaneously |
|
| Colorado Springs |
| Colorado |
| 80909 |
| United States |
| Miami Research | South Miami | Florida | 33143 | United States |
| Advanced Clinical Research- Idaho | Boise | Idaho | 83642 | United States |
| Idaho Falls Infectious diseases | Idaho Falls | Idaho | 83404 | United States |
| Johnson County Clinical Trials | Lenexa | Kansas | 66219 | United States |
| Vince & Associates | Overland Park | Kansas | 66211 | United States |
| Bio-Kinetic | Springfield | Missouri | 65802 | United States |
| Big Sky Clinical Research | Butte | Montana | 59701 | United States |
| Infectious Disease Specialists, PC | Missoula | Montana | 59802 | United States |
| Odyssey Research | Fargo | North Dakota | 88104 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Benchmark | Fort Worth | Texas | 76135 | United States |
| Radiant Research | Salt Lake City | Utah | 84107 | United States |
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
| FG002 | 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 |
| FG003 | Placebo | Participants who received placebo (saline) given one time subcutaneously |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Placebo | Participants who received placebo (saline) given one time subcutaneously |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Serum antibody levels were assessed in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 and Day 28 post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||||
| 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. | Viremia concentrations were assessed in a randomly selected subset of the per-protocol population. | Posted | Number | Participants | Day 2 up to Day 14 post-vaccination |
| |||||||||||||||||||||||||||||||||||||
| 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. | Serum antibody levels and seroconversion were assessed in the per-protocol population. | Posted | Number | Participants | Day 0 and Day 28 post-vaccination |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. | Safety assessments were on the Safety, intend-to-treat Population. | Posted | Number | Participants | Day 0 up to Day 14 post-vaccination |
|
Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 4 | 122 | 51 | 122 | ||
| EG001 | 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 | 1 | 124 | 56 | 124 | ||
| EG002 | 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 | 3 | 112 | 42 | 112 | ||
| EG003 | Placebo | Participants who received placebo (saline) given one time subcutaneously | 5 | 120 | 54 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Vitello intestinal duct remnant | Congenital, familial and genetic disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Accidential poisoning | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Endometrial cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Intracranial aneurysm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D014901 | West Nile Fever |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Day 28 |
|
Participants who received placebo (saline) given one time subcutaneously |
|
|
| OG003 |
| Placebo |
Participants who received placebo (saline) given one time subcutaneously |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|