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Trial record 1 of 1 for:    H-244-004
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Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults (WinVax004)

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ClinicalTrials.gov Identifier: NCT00746798
Recruitment Status : Completed
First Posted : September 4, 2008
Results First Posted : November 2, 2011
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition West Nile Fever
Interventions Biological: ChimeriVax-WN02 vaccine
Biological: Placebo
Enrollment 479
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of 498 of the 479 randomized participants who met the inclusion and exclusion criteria were vaccinated. 1 subject was withdrawn from the study before receiving any study vaccine and was excluded from analysis and this report.
Arm/Group Title ChimeriVax WN02 Vaccine Low Dose ChimeriVax WN02 Vaccine Medium Dose ChimeriVax WN02 Vaccine High Dose Placebo
Hide Arm/Group Description Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously Participants who received placebo (saline) given one time subcutaneously
Period Title: Overall Study
Started 122 124 113 120
Completed 121 122 110 120
Not Completed 1 2 3 0
Reason Not Completed
Protocol Violation             0             1             0             0
Withdrawal by Subject             0             1             1             0
Death             0             0             2             0
Participant unable to return for visit             1             0             0             0
Arm/Group Title ChimeriVax WN02 Vaccine Low Dose ChimeriVax WN02 Vaccine Medium Dose ChimeriVax WN02 Vaccine High Dose Placebo Total
Hide Arm/Group Description Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously Participants who received placebo (saline) given one time subcutaneously Total of all reporting groups
Overall Number of Baseline Participants 122 124 113 120 479
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 124 participants 113 participants 120 participants 479 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
72
  59.0%
75
  60.5%
62
  54.9%
76
  63.3%
285
  59.5%
>=65 years
50
  41.0%
49
  39.5%
51
  45.1%
44
  36.7%
194
  40.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants 124 participants 113 participants 120 participants 479 participants
63.1  (9.39) 62.9  (8.10) 63.4  (9.01) 62.2  (8.28) 62.9  (8.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 124 participants 113 participants 120 participants 479 participants
Female
76
  62.3%
65
  52.4%
63
  55.8%
64
  53.3%
268
  55.9%
Male
46
  37.7%
59
  47.6%
50
  44.2%
56
  46.7%
211
  44.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 122 participants 124 participants 113 participants 120 participants 479 participants
122 124 113 120 479
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine
Hide Description Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.
Time Frame Day 0 and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Serum antibody levels were assessed in the per-protocol population.
Arm/Group Title ChimeriVax WN02 Vaccine Low Dose ChimeriVax WN02 Vaccine Medium Dose ChimeriVax WN02 Vaccine High Dose Placebo
Hide Arm/Group Description:
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
Participants who received placebo (saline) given one time subcutaneously
Overall Number of Participants Analyzed 114 118 108 114
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 0
5.00
(5.00 to 5.00)
5.76
(4.92 to 6.74)
5.06
(4.94 to 5.20)
5.22
(4.80 to 5.68)
Day 28
688
(453 to 1047)
600
(405 to 890)
674
(464 to 978)
5.93
(4.96 to 7.08)
2.Primary Outcome
Title Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Serum antibody levels and seroconversion were assessed in the per-protocol population.
Arm/Group Title ChimeriVax WN02 Vaccine Low Dose ChimeriVax WN02 Vaccine Medium Dose ChimeriVax WN02 Vaccine High Dose Placebo
Hide Arm/Group Description:
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
Participants who received placebo (saline) given one time subcutaneously
Overall Number of Participants Analyzed 114 118 108 114
Measure Type: Number
Unit of Measure: Participants
105 110 103 3
3.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Hide Description [Not Specified]
Time Frame Day 0 up to Day 14 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety assessments were on the Safety, intend-to-treat Population.
Arm/Group Title ChimeriVax WN02 Vaccine Low Dose ChimeriVax WN02 Vaccine Medium Dose ChimeriVax WN02 Vaccine High Dose Placebo
Hide Arm/Group Description:
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
Participants who received placebo (saline) given one time subcutaneously
Overall Number of Participants Analyzed 122 124 112 120
Measure Type: Number
Unit of Measure: Participants
Any Pain [N = 122, 123, 112, 120] 14 29 10 12
Grade 3 Pain (Prevents daily activities) 0 1 0 0
Any Erythema [N = 122, 123, 112, 120] 2 4 0 0
Grade 3 Erythema (> 10 cm) 0 0 0 0
Any Swelling [N = 121, 123, 112, 120] 1 0 0 0
Grade 3 Swelling (> 10 cm) 0 0 0 0
Any Fever [N = 122, 123, 111, 120] 0 0 3 0
Grade 3 Fever (≥ 39.0 ºC or ≥ 102.1 ºF) 0 0 1 0
Any Headache [N = 122, 123, 112, 120] 31 34 33 31
Grade 3 Headache (prevents daily activities) 2 3 3 1
Any Malaise [N = 122, 123, 112, 120] 26 26 27 25
Grade 3 Malaise (Prevents daily activities) 2 4 3 2
Any Myalgia [N = 122, 123, 112, 120] 28 25 22 20
Grade 3 Myalgia (Prevents daily activities) 2 2 1 0
4.Secondary Outcome
Title Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Viremia concentrations were assessed in a randomly selected subset of the per-protocol population.
Arm/Group Title ChimeriVax WN02 Vaccine Low Dose ChimeriVax WN02 Vaccine Medium Dose ChimeriVax WN02 Vaccine High Dose Placebo
Hide Arm/Group Description:
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
Participants who received placebo (saline) given one time subcutaneously
Overall Number of Participants Analyzed 80 82 73 80
Measure Type: Number
Unit of Measure: Participants
Day 2 1 0 1 0
Day 4 33 28 15 0
Day 6 21 33 29 0
Day 8 19 19 21 0
Day 10 15 18 8 1
Day 12 7 5 7 0
Day 14 2 0 2 0
Time Frame Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ChimeriVax WN02 Vaccine Low Dose ChimeriVax WN02 Vaccine Medium Dose ChimeriVax WN02 Vaccine High Dose Placebo
Hide Arm/Group Description Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously Participants who received placebo (saline) given one time subcutaneously
All-Cause Mortality
ChimeriVax WN02 Vaccine Low Dose ChimeriVax WN02 Vaccine Medium Dose ChimeriVax WN02 Vaccine High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ChimeriVax WN02 Vaccine Low Dose ChimeriVax WN02 Vaccine Medium Dose ChimeriVax WN02 Vaccine High Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/122 (3.28%)      1/124 (0.81%)      3/112 (2.68%)      5/120 (4.17%)    
Cardiac disorders         
Angina pectoris * 1  0/122 (0.00%)  0 0/124 (0.00%)  0 0/112 (0.00%)  0 1/120 (0.83%)  1
Atrial fibrillation * 1  1/122 (0.82%)  1 0/124 (0.00%)  0 1/112 (0.89%)  1 0/120 (0.00%)  0
Coronary artery disease * 1  0/122 (0.00%)  0 1/124 (0.81%)  1 0/112 (0.00%)  0 0/120 (0.00%)  0
Myocardial infarction * 1  0/122 (0.00%)  0 0/124 (0.00%)  0 0/112 (0.00%)  0 1/120 (0.83%)  1
Congenital, familial and genetic disorders         
Vitello intestinal duct remnant * 1  0/122 (0.00%)  0 0/124 (0.00%)  0 0/112 (0.00%)  0 1/120 (0.83%)  1
Infections and infestations         
Influenza * 1  0/122 (0.00%)  0 0/124 (0.00%)  0 0/112 (0.00%)  0 2/120 (1.67%)  2
Pneumonia * 1  1/122 (0.82%)  1 0/124 (0.00%)  0 0/112 (0.00%)  0 0/0  0
Injury, poisoning and procedural complications         
Accidential poisoning * 1  0/122 (0.00%)  0 0/124 (0.00%)  0 1/112 (0.89%)  1 0/120 (0.00%)  0
Subdural haematoma * 1  1/122 (0.82%)  1 0/124 (0.00%)  0 0/112 (0.00%)  0 0/120 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/122 (0.00%)  0 0/124 (0.00%)  0 1/112 (0.89%)  1 0/120 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Benign neoplasm of thyroid gland * 1  0/122 (0.00%)  0 0/124 (0.00%)  0 0/112 (0.00%)  0 1/120 (0.83%)  1
Endometrial cancer stage II * 1  1/122 (0.82%)  1 0/124 (0.00%)  0 0/112 (0.00%)  0 0/120 (0.00%)  0
Prostate cancer metastatic * 1  0/122 (0.00%)  0 0/124 (0.00%)  0 1/112 (0.89%)  1 0/120 (0.00%)  0
Intracranial aneurysm * 1  1/122 (0.82%)  1 0/124 (0.00%)  0 0/112 (0.00%)  0 0/120 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
ChimeriVax WN02 Vaccine Low Dose ChimeriVax WN02 Vaccine Medium Dose ChimeriVax WN02 Vaccine High Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/122 (41.80%)      56/124 (45.16%)      42/112 (37.50%)      54/120 (45.00%)    
General disorders         
Injection site pain  1  14/122 (11.48%)  14 29/124 (23.39%)  29 10/112 (8.93%)  10 12/120 (10.00%)  12
Malaise  1  26/122 (21.31%)  26 26/124 (20.97%)  26 27/112 (24.11%)  27 25/120 (20.83%)  25
Infections and infestations         
Nasopharyngitis * 1  4/122 (3.28%)  5 6/124 (4.84%)  6 6/112 (5.36%)  6 8/120 (6.67%)  10
Upper respiratory tract infection * 1  4/122 (3.28%)  5 1/124 (0.81%)  1 2/112 (1.79%)  2 8/120 (6.67%)  9
Musculoskeletal and connective tissue disorders         
Myalgia  1  28/122 (22.95%)  28 25/124 (20.16%)  25 22/112 (19.64%)  22 20/120 (16.67%)  20
Nervous system disorders         
Headache  1  31/122 (25.41%)  31 34/124 (27.42%)  34 33/112 (29.46%)  33 31/120 (25.83%)  31
Respiratory, thoracic and mediastinal disorders         
Cough * 1  7/122 (5.74%)  7 3/124 (2.42%)  4 3/112 (2.68%)  3 7/120 (5.83%)  8
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00746798     History of Changes
Other Study ID Numbers: H-244-004
First Submitted: September 2, 2008
First Posted: September 4, 2008
Results First Submitted: September 27, 2011
Results First Posted: November 2, 2011
Last Update Posted: April 3, 2015