Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine - Full Text View

Sponsored by:	U.S. Army Medical Research and Materiel Command
Information provided by:	U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:	NCT00584844

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	500
Study Start Date:	October 2004
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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).

Detailed Description:

Study Objectives:

Continue to collect safety data on Live NDBR 101, Lot 4 Tularemia Vaccine (primary and booster doses), and
Continue to collect immunogenicity data on Live NDBR 101, Lot 4 Tularemia Vaccine, and
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.

Eligibility

Ages Eligible for Study:	17 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. 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584844

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

Responsible Party:	USAMRMC, USAMMDA ( Robert E. Miller, PhD, Sponsor Representative, Director, Division of Regulated Activities and Compliance )
Study ID Numbers:	A-12775, FY03-24
Study First Received:	December 20, 2007
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00584844
Health Authority:	United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:

Live Vaccine Strain (LVS), Bacterial Infections, Ulceroglandular, Oculoglandular

Study placed in the following topic categories:

Bacterial Infections
Tularemia
Tick-Borne Diseases
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on January 16, 2009