NCT00584844

Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

A Longitudinal Phase 2 Study for the Continued Evaluation of the Safety and Immunogenicity of a Live Francisella Tularensis Vaccine, NDBR 101, Lot 4

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 484 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 17 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is designed to determine the safety and immunogenicity of a Live Francisella tularensis Vaccine

Detailed description

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.

Conditions

• Tularemia

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2004-10-01
• Primary completion: 2009-10-01
• Completion: 2013-10-01
• First posted: 2008-01-02
• Last updated: 2020-01-02
• Results posted: 2017-07-02

Locations

1 site across 1 country: United States