FY15-14: Tularemia Vaccine Protocol (NDBR Lot 4)

NCT03867162 | Withdrawn Phase 2 FDA Drug

• 3 other identifiers: S-15-23FY15-14IND 157
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of the tularemia vaccine, live, attenuated, NDBR 101, Lot 4, and collect data on the incidence of occupational tularemia infection in vaccinated personnel.

Conditions

Tularemia

Outcome Measures

Primary Outcomes (2)

• 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 days after vaccination

• Microagglutination (MA) titer that shows a greater than or equal to 4 fold rise in antibody titer after vaccination

  Seroconversion will be evaluated for subjects who are compliant with the titer schedule

  28-35 days after vaccination

Secondary Outcomes (1)

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

  5 years

Study Arms (1)

Live Attenuated Tularemia Vaccine

EXPERIMENTAL

0.06 mL of Tularemia Vaccine, Live, Attenuated, NDBR 101, Lot 4

Biological: Live Attenuated Tularemia Vaccine

Interventions

Live Attenuated Tularemia Vaccine BIOLOGICAL

Subjects will be vaccinated with a bifurcated needle; approximately 0.06 mL of the reconstituted vaccine will be placed on the volar surface of the forearm and applied by multiple puncture.

Live Attenuated Tularemia Vaccine

Eligibility Criteria

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

You may qualify if:

• Be 18 to 65 years old at time of consent.
• If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccine administration. (Exception: documented hysterectomy or ≥ 3 years of menopause.) The results must be negative. Females must agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination).
• Be considered at risk for exposure to Francisella tularensis (F tularensis) and who have submitted a Request for IND Vaccines for the tularemia vaccine.
• Sign and date the approved informed consent document and HIPAA Authorization.
• Have in their charts:
• medical history (including concomitant medications) within 60 days of planned first administration of vaccine
• physical examination and laboratory tests within 1 year
• Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the principal investigator \[PI\].)
• Be willing to return for all follow-up visits.
• Agree to report any adverse events (AEs) that may or may not be associated with administration of the vaccine for at least 28 days after administration and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study.
• Agree to defer blood donation for 1 year after receipt of the vaccine.

You may not qualify if:

• Have been vaccinated against tularemia or had a documented, confirmed tularemia infection.
• Have received antibiotic therapy within 7 days before vaccination.
• Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (2 times the normal range or at the discretion of the PI). All abnormal laboratory values will be discussed with the research monitor and documented before a subject is enrolled in the trial.
• Have a personal history of an immunodeficiency, splenectomy or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.
• Have confirmed HIV infection.
• Have a positive pregnancy test or be a breastfeeding female.
• Have any known allergies to components of the vaccine:
• Live, attenuated Francisella tularensis
• Modified casein partial hydrolysate (MCPH) broth
• Glucose cysteine hemin agar (GCHA)
• Sucrose Gelatin Agar Stabilizer
• Have administration of blood products (such as blood transfusion, platelet transfusion, immunoglobulin and/or hyperimmune serum), another vaccine or investigational product within 28 days of tularemia vaccination.
• Have any unresolved AE resulting from a previous immunization.
• Have an acute or chronic medical condition (such as acute/chronic kidney disease, pulmonary disease, metabolic disease, skin disease) that, in the judgment of the PI, would impact subject safety.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• US Army Medical Research Institute of Infectious Diseases: collaborator

Study Sites (1)

Special Immunizations Program, Division of Medicine, USAMRIID

Fort Deterick, Maryland, 21702-5009, 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

• Benjamin C Pierson, MD

  USAMRIID

  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: February 14, 2019
• First Posted: March 7, 2019
• Study Start: June 9, 2021
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)