TuberculosisPhase 1NCT03017378
Reactogenicity, Safety and Immunogenicity of a TB/FLU-01L Tuberculosis Vaccine
A Phase 1 study testing TB/FLU-01L in people with Tuberculosis, run by Research Institute for Biological Safety Problems at 1 site in Kazakhstan.
Trial summary
The study is a single centre, phase I, open, randomized, by intranasal and sublingual application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- TB/FLU-01L
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteKazakhstan
- Study dates
- Oct 2013to Feb 2015
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy BCG-vaccinated male or female adult 18 through 50 years of age at the enrollment visit.
- Literate and willing to provide written informed consent.
- A signed informed consent.
- Capable and willing to complete diary cards and willing to return for all follow-up visits.
- For females, willing to take reliable birth control measures throughout the entire period of participation in the study
Who cannot join
- Clinical, radiological (chest X-ray) or laboratory evidence of active or past TB disease.
- Current or past administration of anti-TB therapy.
- History of contact with TB patients.
- Positive QuantiFERON-TB Gold test.
- BCG vaccination in less than 6 months prior to study.
- Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment.
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- Recent history of frequent nose bleeds (>5 within the past year).
- Clinically relevant abnormal paranasal anatomy.
- Recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose.
- Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
- Hypersensitivity after previous administration of any vaccine.
- History of chronic alcohol abuse and/or illegal drug use.
- Any clinically significant abnormal laboratory finding.
- A positive pregnancy test for all women of childbearing potential.
- Administration of immunosuppressive drugs or other immune modifying drugs within 4 weeks prior to study enrollment.
- Acute or chronic clinically significant pulmonary disease, cardiovascular disease, gastrointestinal disease, liver disease, neurological illness, liver disease, blood disease, skin disorder, endocrine disorder, neurological illness and psychiatric disorder as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
- History of leukemia or any other blood or solid organ cancer.
- Seropositive for HIV, hepatitis B surface antigen and/or hepatitis C antibodies.
- Receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4 weeks prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
- Participation in another clinical trial within the previous three months or planned enrollment in such a trial during the period of this study.
- Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
National Center for Tuberculosis Problems, Kazakhstan
Almaty Qalasy, Almaty, 050000
About this study
Official title: A Randomized, Open Clinical Trial Phase 1 Vaccine TB/FLU-01L by Intranasal and Sublingual Application for Specific Immunotherapy Pulmonary Tuberculosis
The study is a single centre, phase I, open, randomized, by intranasal and sublingual application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years.
- Conditions
- Tuberculosis
- Being tested
- TB/FLU-01L
- Keywords
- influenza vector, tuberculosis, vaccine
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB/FLU-01LBiological
TB / FLU-01L (intranasal application)
TB/FLU-01LBiological
TB/FLU-01L (sublingual application)
| Study group | Role | What they receive |
|---|---|---|
| TB/FLU-01L (intranasal application) | Active comparator | Vaccine safety analysis of TB/FLU-01L at double intranasal application in healthy volunteers aged 18 to 50 years. Receives: Biological: TB/FLU-01L |
| TB/FLU-01L (sublingual application) | Active comparator | Vaccine safety analysis of TB/FLU-01L at double sublingual application in healthy volunteers aged 18 to 50 years. Receives: Biological: TB/FLU-01L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE) - Immediate reactions
Commonly Solicited Local reactions associated with injections: pain, erythema/redness, swelling, induration, bruising at the injection site.
Measured: Two hours
Solicited local and systemic reactions
Commonly Solicited general symptoms: fever (oral temperature ≥ 38.0°C), chills, muscle aches/myalgia, arthralgia, fatigue, malaise, headache, rash, sweating, nausea, vomiting, diarrhea and potential indicators of oculo-respiratory syndrome* (ORS).
Measured: Greater than 2 hours after administration of any dose of vaccine through 7 days following any dose
Unsolicited AEs
Unsolicited AEs are any untoward medical occurrence in the subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Measured: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
Serious adverse events (SAEs), including abnormal laboratory findings
Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: Three weeks of receipt of any dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute for Biological Safety Problems
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Kazakhstan, Research Institute of Influenza, Russia
- Responsible party
- Sponsor
- Investigators
- Berik M Khairullin, PhD, Principal investigator, Research Institute for Biological Safety Problems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017378
- Sponsor's protocol ID
- VIT-I-01/2013
- Status last verified
- Jan 2017
- First submitted
- 4 Jan 2017
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Clinical Trial Phase 1 Vaccine TB/FLU-01L by Intranasal and Sublingual Application for Specific Immunotherapy Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT03017378
- Acronym / sponsor ID
- VIT-I-01/2013
- Conditions
- Tuberculosis
- Keywords
- influenza vector, tuberculosis, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Research Institute for Biological Safety ProblemsOther government
- Collaborators
- Ministry of Health, Kazakhstan, Research Institute of Influenza, Russia
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Jan 2017 (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.
The study is a single centre, phase I, open, randomized, by intranasal and sublingual application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TB/FLU-01L (intranasal application) | Active comparator | Biological: TB/FLU-01LVaccine safety analysis of TB/FLU-01L at double intranasal application in healthy volunteers aged 18 to 50 years. |
| TB/FLU-01L (sublingual application) | Active comparator | Biological: TB/FLU-01LVaccine safety analysis of TB/FLU-01L at double sublingual application in healthy volunteers aged 18 to 50 years. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy BCG-vaccinated male or female adult 18 through 50 years of age at the enrollment visit.
- Literate and willing to provide written informed consent.
- A signed informed consent.
- Capable and willing to complete diary cards and willing to return for all follow-up visits.
- For females, willing to take reliable birth control measures throughout the entire period of participation in the study
Key exclusion criteria (21 listed)
- Clinical, radiological (chest X-ray) or laboratory evidence of active or past TB disease.
- Current or past administration of anti-TB therapy.
- History of contact with TB patients.
- Positive QuantiFERON-TB Gold test.
- BCG vaccination in less than 6 months prior to study.
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 |
|---|---|---|
| TB/FLU-01LTB / FLU-01L (intranasal application) | Biological | TB/FLU-01L (intranasal application) |
| TB/FLU-01LTB/FLU-01L (sublingual application) | Biological | TB/FLU-01L (sublingual application) |
Primary outcome
Adverse Events (AE) - Immediate reactions
Time frame: Two hours
Commonly Solicited Local reactions associated with injections: pain, erythema/redness, swelling, induration, bruising at the injection site.
Solicited local and systemic reactions
Time frame: Greater than 2 hours after administration of any dose of vaccine through 7 days following any dose
Commonly Solicited general symptoms: fever (oral temperature ≥ 38.0°C), chills, muscle aches/myalgia, arthralgia, fatigue, malaise, headache, rash, sweating, nausea, vomiting, diarrhea and potential indicators of oculo-respiratory syndrome* (ORS).
Unsolicited AEs
Time frame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
Unsolicited AEs are any untoward medical occurrence in the subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Serious adverse events (SAEs), including abnormal laboratory findings
Time frame: Three weeks of receipt of any dose
Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Berik M Khairullin, PhD principal investigator
Research Institute for Biological Safety Problems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TB/FLU-01L in people with Tuberculosis, run by Research Institute for Biological Safety Problems at 1 site in Kazakhstan.
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 5 inclusion and 21 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: finished, as of the sponsor's last update on 11 Jan 2017. 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 Kazakhstan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events (AE) - Immediate reactions (time frame: Two hours). The study lists 4 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 11 Jan 2017.