Continued Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

NCT00787826 | Unknown Phase 2

• 2 other identifiers: A-15207.aFY 07-15
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tularemia

Keywords

Live Vaccine Strain (LVS)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of tularemia cases following exposure to F. tularensis in a successfully vaccinated individual

  5 years

Study Arms (1)

Vaccination

EXPERIMENTAL

Live Francisella Tularensis Vaccine

Biological: Live Francisella Tularensis Vaccine

Interventions

Live Francisella Tularensis Vaccine BIOLOGICAL

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.

Also known as: LVS Vaccine

Vaccination

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old.
• 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.
• Subjects must be at risk for exposure to F. tularensis.
• 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.
• 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.
• 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.

You may not qualify if:

• Over the age of 65 Years.
• Vaccinated against tularemia within the last 10 years or had a documented, confirmed tularemia infection.
• 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).
• Personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.
• Confirmed HIV\* infection.
• A medical condition that, in the judgment of the Principal Investigator (PI), would impact subject safety.
• Antibiotic therapy within 7 days before vaccination.
• Pregnancy or lactation. Subjects must agree not to become pregnant for 3 months after receipt of the vaccine.
• Any known allergies to any component of the vaccine:
• Modified casein partial hydrolysate medium Glucose cysteine hemin agar Sucrose gelatin agar stabilizer
• Administration of another vaccine within 4 weeks of tularemia vaccination.
• Any unresolved AE resulting from a previous immunization.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, 21702, United States

Location

MeSH Terms

Conditions

Tularemia

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Tick-Borne Diseases; Vector Borne Diseases

Study Officials

• Anthony Cardile, DO

  USAMRIID Medical Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 10, 2008
• Study Start: August 28, 2009
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

US (1)