Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00584844
First received: December 20, 2007
Last updated: August 8, 2012
Last verified: August 2012

December 20, 2007
August 8, 2012
October 2004
April 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00584844 on ClinicalTrials.gov Archive Site
Number of suspected tularemia cases among vaccinated individuals (subjects who achieved microagglutination titer ≥ 1:20) with documented exposure. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Same as current
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 Objectives:

  1. Continue to collect safety data on Live NDBR 101, Lot 4 Tularemia Vaccine (primary and booster doses), and
  2. Continue to collect immunogenicity data on Live NDBR 101, Lot 4 Tularemia Vaccine, and
  3. Provide potential protection for personnel at risk for occupational exposure to F. tularensis and collect data on incidence of occupational tularemia infection (subclinical and clinical) in immunized personnel.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Tularemia
Biological: Live Francisella Tularensis Vaccine
Subjects will receive one drop of reconstituted 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).
No Intervention: No Arm
No Arm
Intervention: Biological: Live Francisella 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
April 2008
April 2008   (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.
Both
17 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584844
A-12775, FY03-24
No
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
August 2012

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