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

NCT03867162 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-08-21

No results posted yet for this study

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.

Conditions

  • Tularemia

Interventions

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.

Sponsors & Collaborators

  • US Army Medical Research Institute of Infectious Diseases

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Benjamin C Pierson, MD · USAMRIID

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-09
Primary Completion
2021-12-17
Completion
2021-12-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867162 on ClinicalTrials.gov