TularemiaPhase 2NDBRNCT03867162
FY15-14: Tularemia Vaccine Protocol (NDBR Lot 4)
A Phase 2 study testing Live Attenuated Tularemia Vaccine in people with Tularemia, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tularemia
- What is being tested?
- Live Attenuated Tularemia Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 17 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Special Immunizations Program, Division of Medicine, USAMRIID
Fort Deterick, Maryland, 21702-5009
About this study
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
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.
Read the 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.
- Conditions
- Tularemia
- Being tested
- Live Attenuated Tularemia Vaccine
- Medical subject headings
- Tularemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Attenuated Tularemia VaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Live Attenuated Tularemia Vaccine | Experimental | 0.06 mL of Tularemia Vaccine, Live, Attenuated, NDBR 101, Lot 4 Receives: Biological: Live Attenuated Tularemia Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 28-35 days after vaccination
Secondary outcomes (1)
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 (positive "take" reaction and seroconversion)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start9 Jun 2021 (estimated)
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Why it stopped: Sponsor terminated this protocol on Dec17, 2021; no subjects have been enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TularemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- US Army Medical Research Institute of Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Benjamin C Pierson, MD, Principal investigator, USAMRIID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867162
- Sponsor's protocol ID
- S-15-23
- Other IDs
- FY15-14, IND 157
- Acronym
- NDBR
- Status last verified
- Aug 2023
- First submitted
- 14 Feb 2019
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03867162
- Acronym / sponsor ID
- NDBR / S-15-23
- Conditions
- Tularemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor terminated this protocol on Dec17, 2021; no subjects have been enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- US Army Medical Research Institute of Infectious Diseases
- Study start
- 9 Jun 2021 (estimated)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Live Attenuated Tularemia Vaccine | Experimental | Biological: Live Attenuated Tularemia Vaccine0.06 mL of Tularemia Vaccine, Live, Attenuated, NDBR 101, Lot 4 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Attenuated Tularemia VaccineSubjects 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. | Biological | Live Attenuated Tularemia Vaccine |
Primary outcome
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
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
1 secondary outcome
Number of tularemia cases following exposure to F. tularensis in a successfully vaccinated individual
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Tularemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin C Pierson, MD principal investigator
USAMRIID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Live Attenuated Tularemia Vaccine in people with Tularemia, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of erythematous papule, vesicle and/or eschar with or without underlying induration (time frame: 7 days after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.