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Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584844
First Posted: January 2, 2008
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
December 20, 2007
January 2, 2008
December 28, 2016
July 2, 2017
July 2, 2017
October 2004
October 2009   (Final data collection date for primary outcome measure)
Safety: Adverse Event Category Rates for All Vaccinations [ Time Frame: AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year ]
AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule.
Safety: The frequency of adverse events in this Francisella tularensis vaccine study will be evaluated for all intent-to-treat subjects; Immunogenicity: Microagglutination assay (MA) and "take" reaction [ Time Frame: AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year ]
Complete list of historical versions of study NCT00584844 on ClinicalTrials.gov Archive Site
  • Immunogenicity: Protocol Compliant Post-primary Titer Rates [ Time Frame: 12 months ]
    Percentage of subjects with less than or greater than titers (> or < 1:20) for compliant post-primary titers.
  • Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates [ Time Frame: 12 months ]
    Percentage of subjects with less than or greater than titers (> or < 1:20) who received post-boost 1
  • Immunogenicity: Protocol-compliant Post-boost 2 Titer [ Time Frame: 12 months ]

    Percentage of subjects with less than or greater than titers who received post-boost 2.

    Responder = > 1:20 Non-responder = < 1:20

Number of suspected tularemia cases among vaccinated individuals (subjects who achieved microagglutination titer ≥ 1:20) with documented exposure. [ Time Frame: Duration of study ]
Not Provided
Not Provided
 
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
This study is designed to determine the safety and immunogenicity of a Live Francisella tularensis Vaccine
Study was designed as a continuation of previously published research and targets subjects who were at risk of occupational exposure to F tularensis virus. Based on screening examinations; if a subject had a positive baseline titer (<1:20) and gave no history of significant exposure to F tularensis or history of tularemia disease, had never received tularemia vaccination, and was at risk of exposure to F tularensis they could be enrolled in this protocol to receive vaccination. Subjects returned for follow-up exams on Days 1, 2, and 7; once between Days 12 and 16; and once between Days 28 and 35 post-vaccination. If titers; after blood samples on Days 28, 35 and 12 months showed <1:20 the vaccination could be repeated at Days 56-84. If the repeat titer remained <1:20, a booster vaccination could be administered. Subjects could be boosted 2 times with 1 year. If the titer measured 12 months after vaccination (+30 days) was >1:20 and the subject had no lingering AEs, the subjects participation was considered complete.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Tularemia
Biological: Live F tularensis Vaccine
Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20).
Experimental: F tularensis Vaccine (0.0025 mL)
Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.
Intervention: Biological: Live F tularensis Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
484
October 2013
October 2009   (Final data collection date for primary outcome measure)

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. Volunteers must agree not to become pregnant for 3 months after receipt of the vaccine.
  • Subject must be actively enrolled in the SIP
  • Subjects must be considered 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. Examinations or tests may be repeated within 1 year at the discretion of the enrolling physician.
  • Volunteer must be willing to return for all follow-up visits on days 1, 2, 7, once between days 12-16, and once between days 28-35, days 56-84 (if needed), all visits for serology, as well as an annual visit while enrolled in protocol.
  • Volunteer 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 volunteer's participation in the study.

Exclusion Criteria:

  • Clinically significant abnormal lab results 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.
  • Any other medical condition at the discretion of the PI.
  • Antibiotic therapy for 7 days before vaccination.
  • Females must not be pregnant or lactating (females must agree to not become pregnant for 3 months after vaccination).
  • Any known allergies to excipients 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.
Sexes Eligible for Study: All
17 Years to 65 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00584844
A-12775
FY03-24 ( Other Identifier: SIP )
No
Not Provided
Not Provided
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
Not Provided
Principal Investigator: Mark Goldberg, MD USAMRIID Medical Division
U.S. Army Medical Research and Materiel Command
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP