NCT00787826

Continued 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 in Healthy Adults At-Risk for Exposure to Francisella Tularensis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 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 Objectives: 1. To assess the safety of live F. tularensis vaccine NDBR 101. 2. To assess the immunogenicity of live F. tularensis vaccine NDBR 101.

Conditions

• Tularemia

Interventions

Type	Name	Description
BIOLOGICAL	Live Francisella Tularensis Vaccine	Approximately 0.0025 mL of vaccine will be administered percutaneously with a bifurcated needle using 15 pricks on the volar surface of the forearm. Vaccination may be repeated up to two times within the year if successful vaccination is not demonstrated by a positive "take" reaction and a MA titer of ≥ 1:20.

Timeline

• Start date: 2009-08-28
• Primary completion: 2019-11-01
• Completion: 2021-12-01
• First posted: 2008-11-10
• Last updated: 2021-04-29

Locations

1 site across 1 country: United States