Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine
|ClinicalTrials.gov Identifier: NCT00584844|
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
|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
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|