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Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584844
First Posted: January 2, 2008
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
Results First Submitted: December 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Tularemia
Intervention: Biological: Live F tularensis Vaccine

  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
Enrollment at the Special Immunizations Clinic at USAMRIID is expected to last 5 years and include up to 1,000 subjects who were at risk of occupational exposure to F tularensis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
F Tularensis Vaccine (0.0025 mL)

Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.

Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20).


Participant Flow:   Overall Study
    F Tularensis Vaccine (0.0025 mL)
STARTED   484 
COMPLETED   405 
NOT COMPLETED   79 
Withdrawal by Subject                59 
Screen Failure                20 



  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
F Tularensis Vaccine (0.0025 mL)

Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.

Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20).


Baseline Measures
   F Tularensis Vaccine (0.0025 mL) 
Overall Participants Analyzed 
[Units: Participants]
 405 
Age, Customized 
[Units: Participants]
Count of Participants
 
<20 years   2 
20-29 years   108 
30-39 years   126 
40-49 years   106 
50-59 years   54 
60-69 years   9 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      145  35.8% 
Male      260  64.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      23   5.7% 
Not Hispanic or Latino      382  94.3% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      2   0.5% 
Asian      13   3.2% 
Native Hawaiian or Other Pacific Islander      2   0.5% 
Black or African American      20   4.9% 
White      357  88.1% 
More than one race      11   2.7% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   405 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety: Adverse Event Category Rates for All Vaccinations   [ Time Frame: AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year ]

2.  Secondary:   Immunogenicity: Protocol Compliant Post-primary Titer Rates   [ Time Frame: 12 months ]

3.  Secondary:   Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates   [ Time Frame: 12 months ]

4.  Secondary:   Immunogenicity: Protocol-compliant Post-boost 2 Titer   [ Time Frame: 12 months ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Mark Goldberg, MD
Organization: USAMRIID
phone: 301-619-4562
e-mail: mark.goldberg@amedd.mil



Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00584844     History of Changes
Other Study ID Numbers: A-12775
FY03-24 ( Other Identifier: SIP )
First Submitted: December 20, 2007
First Posted: January 2, 2008
Results First Submitted: December 28, 2016
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017