Clinical trial NCT00584844: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tularemia
Keywords: Live Vaccine Strain (LVS), Bacterial Infections, Ulceroglandular, Oculoglandular
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2008-01-02
Enrollment: 484
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
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 was designed as a continuation of previously published research and targets subjects who were at risk of occupational exposure to F tularensis virus. Based on screening examinations; if a subject had a positive baseline titer (\<1:20) and gave no history of significant exposure to F tularensis or history of tularemia disease, had never received tularemia vaccination, and was at risk of exposure to F tularensis they could be enrolled in this protocol to receive vaccination. Subjects returned for follow-up exams on Days 1, 2, and 7; once between Days 12 and 16; and once between Days 28 and 35 post-vaccination. If titers; after blood samples on Days 28, 35 and 12 months showed \<1:20 the vaccination could be repeated at Days 56-84. If the repeat titer remained \<1:20, a booster vaccination could be administered. Subjects could be boosted 2 times with 1 year. If the titer measured 12 months after vaccination (+30 days) was \>1:20 and the subject had no lingering AEs, the subjects participation was considered complete.

Eligibility 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. \>

Primary outcomes:
measure: Safety: Adverse Event Category Rates for All Vaccinations
timeFrame: AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year
Secondary outcomes:
measure: Immunogenicity: Protocol Compliant Post-primary Titer Rates
timeFrame: 12 months
measure: Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates
timeFrame: 12 months
measure: Immunogenicity: Protocol-compliant Post-boost 2 Titer
timeFrame: 12 months
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: Mark Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References: