Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

NCT00584844 | Completed Phase 2 Results

• 2 other identifiers: A-12775FY03-24
• Study Type: interventional
• Target: 484
• 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), Bacterial Infections, Ulceroglandular, Oculoglandular

Outcome Measures

Primary Outcomes (1)

• Safety: Adverse Event Category Rates for All Vaccinations

  AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule.

  AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year

Secondary Outcomes (3)

• Immunogenicity: Protocol Compliant Post-primary Titer Rates

  12 months

• Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates

  12 months

• Immunogenicity: Protocol-compliant Post-boost 2 Titer

  12 months

Study Arms (1)

F tularensis Vaccine (0.0025 mL)

EXPERIMENTAL

Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.

Biological: Live F tularensis Vaccine

Interventions

Live F tularensis Vaccine BIOLOGICAL

Subjects will receive one drop of reconstituted F tularensis 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).

F tularensis Vaccine (0.0025 mL)

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. \>

You may not qualify if:

• 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. \>

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; Bacterial Infections

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Mark Goldberg, MD
• Organization: USAMRIID

mark.goldberg@amedd.mil

301-619-4562

Study Officials

• Mark Goldberg, MD

  USAMRIID Medical Division

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: December 20, 2007
• First Posted: January 2, 2008
• Study Start: October 1, 2004
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2013
• Last Updated: January 2, 2020
• Results First Posted: July 2, 2017

Record last verified: 2019-12

Locations

US (1)