TularemiaPhase 2NCT00787826
Continued Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine
A Phase 2 study testing Live Francisella Tularensis Vaccine in people with Tularemia, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
This study is designed to determine the safety and immunogenicity of a Live Francisella tularensis Vaccine 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 Francisella Tularensis Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2009to 1 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
- At least 18 years old.
- 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.
- Subjects must be at risk for exposure to F. tularensis.
- 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.
- 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.
- 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.
Who cannot join
- Over the age of 65 Years.
- Vaccinated against tularemia within the last 10 years or had a documented, confirmed tularemia infection.
- 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).
- Personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.
- Confirmed HIV* infection.
- A medical condition that, in the judgment of the Principal Investigator (PI), would impact subject safety.
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- Antibiotic therapy within 7 days before vaccination.
- Pregnancy or lactation. Subjects must agree not to become pregnant for 3 months after receipt of the vaccine.
- Any known allergies to any component of the vaccine:
- Modified casein partial hydrolysate medium Glucose cysteine hemin agar Sucrose gelatin agar stabilizer
- Administration of another vaccine within 4 weeks of tularemia vaccination.
- Any unresolved AE resulting from a previous immunization.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, 21702
About this study
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
This study is designed to determine the safety and immunogenicity of a Live Francisella tularensis Vaccine
Read the detailed description
Study Objectives:
- To assess the safety of live F. tularensis vaccine NDBR 101.
- To assess the immunogenicity of live F. tularensis vaccine NDBR 101.
- Conditions
- Tularemia
- Being tested
- Live Francisella Tularensis Vaccine
- Keywords
- Live Vaccine Strain (LVS)
- Medical subject headings
- Tularemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Francisella Tularensis VaccineBiological
Also called LVS 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.
| Study group | Role | What they receive |
|---|---|---|
| Vaccination | Experimental | Live Francisella Tularensis Vaccine Receives: Biological: Live Francisella Tularensis Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 years
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 (± 2 days) after vaccination
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.
Measured: 28-35 days
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 individual (positive "take" reaction and seroconversion [≥ 4-fold rise in antibody titer after vaccination]).
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 posted10 Nov 2008 (estimated)
- Study start28 Aug 2009
- Primary completion1 Nov 2019
- Study completion1 Dec 2021 (estimated)
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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Anthony Cardile, DO, Principal investigator, USAMRIID Medical Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787826
- Sponsor's protocol ID
- A-15207.a
- Other IDs
- FY 07-15
- Status last verified
- Apr 2021
- First submitted
- 5 Nov 2008
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00787826
- Acronym / sponsor ID
- A-15207.a
- Conditions
- Tularemia
- Keywords
- Live Vaccine Strain (LVS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- 28 Aug 2009 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 10 Nov 2008 (estimated)
- 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.
This study is designed to determine the safety and immunogenicity of a Live Francisella tularensis Vaccine
Detailed description
Study Objectives:
- To assess the safety of live F. tularensis vaccine NDBR 101.
- To assess the immunogenicity of live F. tularensis vaccine NDBR 101.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccination | Experimental | Biological: Live Francisella Tularensis VaccineLive Francisella Tularensis Vaccine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years old.
- 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.
- Subjects must be at risk for exposure to F. tularensis.
- 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.
- 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.
Key exclusion criteria (12 listed)
- Over the age of 65 Years.
- Vaccinated against tularemia within the last 10 years or had a documented, confirmed tularemia infection.
- 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).
- Personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.
- 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 Francisella Tularensis VaccineAlso: LVS VaccineApproximately 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. | Biological | Vaccination |
Primary outcome
Number for adverse events.
Time frame: 5 years
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).
Number of erythematous papule, vesicle, and/or eschar with or without underlying induration
Time frame: 7 (± 2 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 ≥ 4-fold rise in antibody titer after vaccination.
Time frame: 28-35 days
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.
1 secondary outcome
Number of tularemia cases following exposure to F. tularensis in a successfully vaccinated individual
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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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.
Anthony Cardile, DO principal investigator
USAMRIID Medical Division
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 Francisella Tularensis 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Apr 2021. 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?
Results are not available in the source record.
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 for adverse events. (time frame: 5 years). The study lists 3 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 29 Apr 2021.