Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

Tularemia Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Tularemia

• NCT number: NCT00584844
• Study type: Interventional
• Source: U.S. Army Medical Research and Development Command
• Status: Completed
• Phase: Phase 2
• Start date: October 2004
• Completion date: October 2013