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: April 20, 2015
Last verified: April 2015
  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 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:
  • Number for adverse events. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The nature (body system affected, type (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 (all subjects receiving one or more vaccinations under this protocol).

  • Number of erythematous papule, vesicle, and/or eschar with or without underlying induration [ Time Frame: 7 (± 2 days) after vaccination ] [ Designated as safety issue: Yes ]
    Incidence of positive "take" reaction (development of an erythematous papule, vesicle, and/or eschar with or without underlying induration) following vaccination for all subjects regardless of compliance.

  • Microagglutination (MA) titer that shows a ≥ 4-fold rise in antibody titer after vaccination. [ Time Frame: 28-35 days ] [ Designated as safety issue: No ]

    Seroconversion will be evaluated for subjects who are compliant with the titer schedule.

    Seroconversion is defined as microagglutination (MA) titer that shows a ≥ 4-fold rise in antibody titer after vaccination.



Secondary Outcome Measures:
  • Number of tularemia cases following exposure to F. tularensis in a successfully vaccinated individual [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Documented occurrence of tularemia following exposure to F. tularensis in a successfully vaccinated individual (positive "take" reaction and seroconversion [≥ 4-fold rise in antibody titer after vaccination]).


Estimated Enrollment: 1000
Study Start Date: January 2009
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: November 2015 (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:

  1. At least 18 years old.
  2. Females of childbearing potential must agree to have a urine or serum pregnancy test on vaccination day, 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.
  3. Subjects must be at risk for exposure to F. tularensis.
  4. Subjects must have an up-to-date (within 1 year) medical history including concomitant medications, physical examination, and laboratory tests on their charts and be medically cleared for participation by an investigator.
  5. Subject must be willing to return for all follow-up visits on days 1 and 2, between days 5-9, 12-16, 28-35, and 56-84 (if needed), all visits for serology, and the closeout interview 6 months (±14 days) after vaccination or revaccination.
  6. 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.

Exclusion Criteria:

  1. Over the age of 65 Years.
  2. Vaccinated against tularemia within the last 10 years or had a documented, confirmed tularemia infection.
  3. Clinically significant abnormal lab results including evidence of hepatitis C, hepatitis B carrier state, or elevated liver function tests (two times the normal range or at the discretion of the PI).
  4. Personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.
  5. Confirmed HIV* infection.
  6. A medical condition that, in the judgment of the Principal Investigator (PI), would impact subject safety.
  7. Antibiotic therapy within 7 days before vaccination.
  8. Pregnancy or lactation. Subjects must agree not to become pregnant for 3 months after receipt of the vaccine.
  9. Any known allergies to any component of the vaccine:

    Modified casein partial hydrolysate medium Glucose cysteine hemin agar Sucrose gelatin agar stabilizer

  10. Administration of another vaccine within 4 weeks of tularemia vaccination.
  11. Any unresolved AE resulting from a previous immunization.
  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: Mark Goldberg, 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: April 20, 2015
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 01, 2015