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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03867162
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
United States Army Medical Research Institute of Infectious Diseases
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

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.

Condition or disease Intervention/treatment Phase
Tularemia Biological: Live Attenuated Tularemia Vaccine Phase 2

Detailed Description:

This protocol is replacing NCT00787826 (S-09-15; FY07-15)

The study population will consist of USAMRIID and qualified extramural participants who are at risk of exposure to tularemia bacteria. This study will be performed at the USAMRIID SIP Clinic. This open-label study represents a continuation of previous research conducted at USAMRIID.

After the enrollment and approval for participation, each subject 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. The subject will return for follow-up examination on Days 1 and 2; between Days 5-9, 12-16, and 28-35; and at 6 months (± 14 days) after vaccination for clinical evaluation of AEs and to document responses to the vaccine. Additionally, the subject may be asked to return between Days 56-84 for a repeat titer if indicated and ordered by an investigator on the study. The subject's participation in this study will be considered complete at 6 months ± 14 days after vaccination or revaccination. Following documentation of a positive "take" reaction and a titer showing a ≥ 4-fold increase, routine repeat vaccinations or serosurveillance upon continued exposure to the organism are not included in this protocol.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 2 Open-Label Safety and Immunogenicity Study of Tularemia Vaccine, Live, Attenuated (NDBR 101, Lot 4) in Adult Subjects at Risk of Exposure to Tularemia Bacteria
Estimated Study Start Date : December 9, 2019
Estimated Primary Completion Date : June 4, 2024
Estimated Study Completion Date : June 4, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Live Attenuated Tularemia Vaccine
0.06 mL of Tularemia Vaccine, Live, Attenuated, NDBR 101, Lot 4
Biological: Live Attenuated Tularemia Vaccine
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.




Primary Outcome Measures :
  1. Number of erythematous papule, vesicle and/or eschar with or without underlying induration [ Time Frame: 7 days after vaccination ]
    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

  2. Microagglutination (MA) titer that shows a greater than or equal to 4 fold rise in antibody titer after vaccination [ Time Frame: 28-35 days after vaccination ]
    Seroconversion will be evaluated for subjects who are compliant with the titer schedule


Secondary Outcome Measures :
  1. Number of tularemia cases following exposure to F. tularensis in a successfully vaccinated individual [ Time Frame: 5 years ]
    Documented occurrence of tularemia following exposure to F. tularensis in a successfully vaccinated (positive "take" reaction and seroconversion)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be 18 to 65 years old at time of consent.
  2. 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).
  3. Be considered at risk for exposure to Francisella tularensis (F tularensis) and who have submitted a Request for IND Vaccines for the tularemia vaccine.
  4. Sign and date the approved informed consent document and HIPAA Authorization.
  5. Have in their charts:

    1. medical history (including concomitant medications) within 60 days of planned first administration of vaccine
    2. physical examination and laboratory tests within 1 year
  6. Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the principal investigator [PI].)
  7. Be willing to return for all follow-up visits.
  8. 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.
  9. Agree to defer blood donation for 1 year after receipt of the vaccine.

Exclusion Criteria:

  1. Have been vaccinated against tularemia or had a documented, confirmed tularemia infection.
  2. Have received antibiotic therapy within 7 days before vaccination.
  3. 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.
  4. 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.
  5. Have confirmed HIV infection.
  6. Have a positive pregnancy test or be a breastfeeding female.
  7. Have any known allergies to components of the vaccine:

    1. Live, attenuated Francisella tularensis
    2. Modified casein partial hydrolysate (MCPH) broth
    3. Glucose cysteine hemin agar (GCHA)
    4. Sucrose Gelatin Agar Stabilizer
  8. 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.
  9. Have any unresolved AE resulting from a previous immunization.
  10. 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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867162


Contacts
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Contact: Phillip R Pittman, MD 301-619-2997 phillip.r.pittman.civ@mail.mil

Locations
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United States, Maryland
Special Immunizations Program, Division of Medicine, USAMRIID Not yet recruiting
Fort Deterick, Maryland, United States, 21702-5009
Contact: Jeannine Haller, RN, CCRP    301-619-4652    jeannine.Haller.civ@mail.mil   
Sponsors and Collaborators
U.S. Army Medical Research and Development Command
United States Army Medical Research Institute of Infectious Diseases
Investigators
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Principal Investigator: Phillip R Pittman, MD USAMRIID

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Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT03867162     History of Changes
Other Study ID Numbers: S-15-23
FY15-14 ( Other Identifier: USAMRIID )
IND 157 ( Other Identifier: Food and Drug Administration )
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tularemia
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs