Continued Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

Tularemia Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00787826
• Other study ID #: A-15207.a
• Secondary ID: FY 07-15
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: August 28, 2009
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2021
• Source: U.S. Army Medical Research and Development Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 1, 2021
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tularemia

Intervention

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.

Locations

Country	Name	City	State
United States	U.S. Army Medical Research Institute of Infectious Diseases	Fort Deterick	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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