Continued 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 in Healthy Adults At-Risk for Exposure to Francisella Tularensis

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Tularemia
• Intervention / Treatment: Biological: Live Francisella Tularensis 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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Fort Deterick, Maryland, United States, 21702
      • U.S. Army Medical Research Institute of Infectious Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: LVS Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number for adverse events.	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).	5 years
Number of erythematous papule, vesicle, and/or eschar with or without underlying induration	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.	7 (± 2 days) after vaccination
Microagglutination (MA) titer that shows a ≥ 4-fold rise in antibody titer after vaccination.	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.	28-35 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of tularemia cases following exposure to F. tularensis in a successfully vaccinated individual	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]).	5 years

Collaborators and Investigators

• Sponsor: U.S. Army Medical Research and Development Command
• Investigators: Principal Investigator: Anthony Cardile, DO, USAMRIID Medical Division

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2009
• Primary Completion (Actual): November 1, 2019
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 5, 2008
• First Submitted That Met QC Criteria: November 6, 2008
• First Posted (Estimate): November 10, 2008

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Live Vaccine Strain (LVS)
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Tick-Borne Diseases; Tularemia; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: A-15207.a; FY 07-15 (Other Identifier: SIP)