Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00442169
First received: February 27, 2007
Last updated: January 17, 2014
Last verified: January 2014
Results First Received: January 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: West Nile Fever
Interventions: Biological: ChimeriVax-WN02 Low Dose
Biological: ChimeriVax-WN02 Medium Dose
Biological: ChimeriVax-WN02 High Dose
Biological: 0.9% Saline solution
Biological: 0.9 % NaCl solution

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 09 December 2005 to 27 March 2006 in 5 clinical centers in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo (Part 1) Participants in Part 1 of the study who received a single dose of saline on Day 0
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
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
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
Placebo (Part 2) Participants in Part 2 of the study who received a placebo vaccine on Day 0
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

Participant Flow for 2 periods

Period 1:   Part 1
    Placebo (Part 1)     WN02 Low Dose (Part 1)     WN02 Medium Dose (Part 1)     WN02 High Dose (Part 1)     Placebo (Part 2)     WNO2 High Dose (Part 2)  
STARTED     17     24     40     31     0 [1]   0 [1]
COMPLETED     17     24     40     31     0     0  
NOT COMPLETED     0     0     0     0     0     0  
[1] Participants in Part 2 are not the same as those in Part 1

Period 2:   Part 2
    Placebo (Part 1)     WN02 Low Dose (Part 1)     WN02 Medium Dose (Part 1)     WN02 High Dose (Part 1)     Placebo (Part 2)     WNO2 High Dose (Part 2)  
STARTED     0 [1]   0 [1]   0 [1]   0 [1]   25     57  
COMPLETED     0     0     0     0     25     57  
NOT COMPLETED     0     0     0     0     0     0  
[1] Participants in Part 1 are not the same as those in Part 2



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo (Part 1) Participants in Part 1 of the study who received a single dose of saline on Day 0
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
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
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
Placebo (Part 2) Participants in Part 2 of the study who received a placebo vaccine on Day 0
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
Total Total of all reporting groups

Baseline Measures
    Placebo (Part 1)     WN02 Low Dose (Part 1)     WN02 Medium Dose (Part 1)     WN02 High Dose (Part 1)     Placebo (Part 2)     WNO2 High Dose (Part 2)     Total  
Number of Participants  
[units: participants]
  17     24     40     31     25     57     194  
Age  
[units: Participants]
             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     17     24     40     31     11     29     152  
>=65 years     0     0     0     0     14     28     42  
Age  
[units: Years]
Mean ± Standard Deviation
  26.6  ± 6.41     25.4  ± 5.62     25  ± 5.43     25.1  ± 6.47     61.4  ± 11.8     61.0  ± 11.3     25.7  ± 6.13  
Gender  
[units: Participants]
             
Female     8     12     19     13     22     40     114  
Male     9     12     21     18     3     17     80  
Region of Enrollment  
[units: Participants]
             
United States     17     24     40     31     25     57     194  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion).   [ Time Frame: Day 28 post-vaccination ]

2.  Primary:   Number of Viremic Participants Post-vaccination   [ Time Frame: Day 21 post-vaccination ]

3.  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 ]

4.  Secondary:   Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination.   [ Time Frame: Days 0, 14, and 28 post-vaccination ]

5.  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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com


No publications provided by Sanofi

Publications automatically indexed to this study:

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00442169     History of Changes
Other Study ID Numbers: H-244-003
Study First Received: February 27, 2007
Results First Received: January 21, 2011
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration