Clinical trial NCT00787826: Continued Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine
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 in Healthy Adults At-Risk for Exposure to Francisella Tularensis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tularemia
Keywords: Live Vaccine Strain (LVS)
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2008-11-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is designed to determine the safety and immunogenicity of a 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number for adverse events.
timeFrame: 5 years
measure: Number of erythematous papule, vesicle, and/or eschar with or without underlying induration
timeFrame: 7 (± 2 days) after vaccination
measure: Microagglutination (MA) titer that shows a ≥ 4-fold rise in antibody titer after vaccination.
timeFrame: 28-35 days
Secondary outcomes:
measure: Number of tularemia cases following exposure to F. tularensis in a successfully vaccinated individual
timeFrame: 5 years
Other outcomes:
Locations:
city: Fort Deterick
country: United States
facility: U.S. Army Medical Research Institute of Infectious Diseases
state: Maryland
Study officials:
affiliation: USAMRIID Medical Division
name: Anthony Cardile, DO
role: PRINCIPAL_INVESTIGATOR
References: