Continued Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00787826
First received: November 5, 2008
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Tularemia
Biological: Live Francisella Tularensis Vaccine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multi-Site 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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Safety:The nature (body system affected,(local or systemic), severity,frequency of occurrence, relationship to vaccine, treatment or intervention offered if any, and resolution or outcome) and frequency of adverse events for the assessment population. [ Time Frame: AEs recorded 28 days after vaccination/SAEs recorded through duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Primary Immunogenicity: positive "take" reaction; Secondary Immunogenicity: Microagglutination (MA) titers. Tertiary Immunogenicity: Occurrence of tularemia following exposure to F. tularensis in a successfully vaccinated individual. [ Time Frame: take reaction will be assessed up to day 7 (± 2 days) after vaccination; MA titers will be assessed on days 0, 28-35, and 56-84 after vaccination. ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccination
Live Francisella Tularensis Vaccine
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.
Other Name: LVS 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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years old, or if on active military duty, 17 years old
  • Females of childbearing potential must agree to have a urine pregnancy test immediately before vaccination (Exception: documented hysterectomy or > 3 years of menopause). The results must be negative. Subjects must agree not to become pregnant for 3 months after receipt of the vaccine.
  • Subject must be actively enrolled in the SIP at USAMRIID to be vaccinated at USAMRIID.
  • Subjects must be at risk for exposure to F. tularensis.
  • Subjects must have an up-to-date (within 1 year) medical history, physical examination, and laboratory tests on their charts and be medically cleared for participation by an investigator.

Exclusion Criteria:

  • Over 65 years of age.
  • Individuals with MA titer ≥1:20 who have history of significant exposure (as determined by the PI) to F. tularensis (i.e., raised rabbits, hunted and skinned rabbits, etc.).
  • Clinically significant abnormal lab results (within 60 days before vaccination) including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests (2X normal values) or at discretion of PI.
  • Personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.
  • Confirmed HIV infection.
  • A medical condition that, in the judgment of the Principal Investigator (PI), would impact subject safety.
  • Antibiotic therapy within 7 days before vaccination.
  • Pregnancy or lactation.
  • Any known allergies to any components of the vaccine.
  • Administration of another live vaccine within 4 weeks or an inactivated vaccine (generally) within 7 days of tularemia vaccination.
  • Any unresolved adverse event resulting from a previous immunization.
  • Subject must agree to report any adverse event which may or may not be associated with administration of the test article for at least 28 days after vaccination. All serious and unexpected adverse events will be reported for the duration of the subject's participation in the study.
  • Subject must be willing to return for all follow-up visits on days 1 and 2 and between days 5-9, 12-16, 28-35, and 56-84 (if needed), all visits for serology, and the close-out interview 4 months (±14 days) after vaccination or revaccination.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787826

Locations
United States, Maryland
U.S. Army Medical Research Institute of Infectious Diseases
Fort Detrick, Maryland, United States, 21702
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Robert Rivard, MD USAMRIID Medical Division
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00787826     History of Changes
Other Study ID Numbers: A-15207.a, FY 07-15
Study First Received: November 5, 2008
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Live Vaccine Strain (LVS)

ClinicalTrials.gov processed this record on September 22, 2014