Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine
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|ClinicalTrials.gov Identifier: NCT00584844|
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : July 2, 2017
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tularemia||Biological: Live F tularensis Vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||484 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Longitudinal Phase 2 Study for the Continued Evaluation of the Safety and Immunogenicity of a Live Francisella Tularensis Vaccine, NDBR 101, Lot 4|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2013|
Experimental: 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.
Biological: 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).
- 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 ]AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule.
- Immunogenicity: Protocol Compliant Post-primary Titer Rates [ Time Frame: 12 months ]Percentage of subjects with less than or greater than titers (> or < 1:20) for compliant post-primary titers.
- Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates [ Time Frame: 12 months ]Percentage of subjects with less than or greater than titers (> or < 1:20) who received post-boost 1
- Immunogenicity: Protocol-compliant Post-boost 2 Titer [ Time Frame: 12 months ]
Percentage of subjects with less than or greater than titers who received post-boost 2.
Responder = > 1:20 Non-responder = < 1:20
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584844
|United States, Maryland|
|U.S. Army Medical Research Institute of Infectious Diseases|
|Fort Deterick, Maryland, United States, 21702|
|Principal Investigator:||Mark Goldberg, MD||USAMRIID Medical Division|