This study is designed to determine the safety and immunogenicity of a Live Francisella tularensis Vaccine
Study was designed as a continuation of previously published research and targets subjects who were at risk of occupational exposure to F tularensis virus. Based on screening examinations; if a subject had a positive baseline titer (\<1:20) and gave no history of significant exposure to F tularensis or history of tularemia disease, had never received tularemia vaccination, and was at risk of exposure to F tularensis they could be enrolled in this protocol to receive vaccination. Subjects returned for follow-up exams on Days 1, 2, and 7; once between Days 12 and 16; and once between Days 28 and 35 post-vaccination. If titers; after blood samples on Days 28, 35 and 12 months showed \<1:20 the vaccination could be repeated at Days 56-84. If the repeat titer remained \<1:20, a booster vaccination could be administered. Subjects could be boosted 2 times with 1 year. If the titer measured 12 months after vaccination (+30 days) was \>1:20 and the subject had no lingering AEs, the subjects participation was considered complete.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
484
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).
U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, United States
Safety: Adverse Event Category Rates for All Vaccinations
AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule.
Time frame: AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year
Immunogenicity: Protocol Compliant Post-primary Titer Rates
Percentage of subjects with less than or greater than titers (\> or \< 1:20) for compliant post-primary titers.
Time frame: 12 months
Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates
Percentage of subjects with less than or greater than titers (\> or \< 1:20) who received post-boost 1
Time frame: 12 months
Immunogenicity: Protocol-compliant Post-boost 2 Titer
Percentage of subjects with less than or greater than titers who received post-boost 2. Responder = \> 1:20 Non-responder = \< 1:20
Time frame: 12 months
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