NCT03867162

FY15-14: Tularemia Vaccine Protocol (NDBR Lot 4)

Phase 2 Open-Label Safety and Immunogenicity Study of Tularemia Vaccine, Live, Attenuated (NDBR 101, Lot 4) in Adult Subjects at Risk of Exposure to Tularemia Bacteria

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of the tularemia vaccine, live, attenuated, NDBR 101, Lot 4, and collect data on the incidence of occupational tularemia infection in vaccinated personnel.

Detailed description

This protocol is replacing NCT00787826 (S-09-15; FY07-15) The study population will consist of USAMRIID and qualified extramural participants who are at risk of exposure to tularemia bacteria. This study will be performed at the USAMRIID SIP Clinic. This open-label study represents a continuation of previous research conducted at USAMRIID. After the enrollment and approval for participation, each subject will be vaccinated with a bifurcated needle; approximately 0.06 mL of the reconstituted vaccine will be placed on the volar surface of the forearm and applied by multiple puncture. The subject will return for follow-up examination on Days 1 and 2; between Days 5-9, 12-16, and 28-35; and at 6 months (± 14 days) after vaccination for clinical evaluation of AEs and to document responses to the vaccine. Additionally, the subject may be asked to return between Days 56-84 for a repeat titer if indicated and ordered by an investigator on the study. The subject's participation in this study will be considered complete at 6 months ± 14 days after vaccination or revaccination. Following documentation of a positive "take" reaction and a titer showing a ≥ 4-fold increase, routine repeat vaccinations or serosurveillance upon continued exposure to the organism are not included in this protocol.

Conditions

• Tularemia

Interventions

Type	Name	Description
BIOLOGICAL	Live Attenuated Tularemia Vaccine	Subjects will be vaccinated with a bifurcated needle; approximately 0.06 mL of the reconstituted vaccine will be placed on the volar surface of the forearm and applied by multiple puncture.

Timeline

• Start date: 2021-06-09
• Primary completion: 2021-12-17
• Completion: 2021-12-17
• First posted: 2019-03-07
• Last updated: 2023-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study