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TuberculosisPhase 2NCT06873282

Phase 2 Study of the ТВ/Flu-05Е Tuberculosis Vaccine

A Phase 2 study testing TB/Flu-05E in people with Tuberculosis, run by Research Institute of Influenza, Russia at 3 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to investigate immunogenicity and safety of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers 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-05E
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
3 sitesRussia
Study dates
13 Dec 2023to 11 Apr 2024
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy BCG-vaccinated men and women aged 18 to 50 years
  • Availability of signed informed consent
  • Diagnosed "healthy" according to the data of standard clinical, laboratory and instrumental examination methods, with the absence of clinically significant changes. Participants with chronic conditions that do not require special treatment, such as diabetes mellitus, hypertension, or heart disease, are eligible to participate in this study if the investigator considers the participant's condition to be medically stable
  • The ability and willingness to make entries in the diary of self-observation, as well as to carry out all the visits foreseen in the study for control medical observation
  • Consent of study participants to use effective contraceptive methods throughout their participation in the study. In this study, volunteers can use the following methods of contraception:
  • Barrier methods:
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  • male condom and spermicide
  • cervical cap and spermicide
  • vaginal diaphragm and spermicide
  • Intrauterine device
  • Hormonal intrauterine device
  • Hormonal contraceptives:
  • hormonal implants
  • hormone injections
  • combined oral contraceptives
  • mini-pill
  • contraceptive patch
  • Abstinence from sexual activity.
  • Body weight ≥ 50 kg
  • Negative test for alcohol in exhaled air
  • Values of the complete blood count and biochemical blood analysis (during the screening) within 0.9*reference range lower limit and 1,1 * reference range upper limit
  • Negative tests for HIV, hepatitis B, hepatitis C, and syphilis
  • Absence of pathological changes on the chest X-ray (fluorogram of the lungs).

Who cannot join

  • Participation in another clinical study within three months prior to the start of the current study; planning to participate in another study during the current study period
  • Clinical, radiological or laboratory signs of active or previously transferred tuberculosis of any localization.
  • Existence in the past or present of contact with patients with any form of tuberculosis (at home, at work, in the circle of friends and acquaintances)
  • Tuberculous infection confirmed by the TB-FERON IGRA laboratory test
  • Immunization with BCG within six months prior to enrollment in the current study
  • Contact with COVID-19 patients within 14 days prior to the start of the clinical study
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  • Positive rapid test result for SARS-CoV-2 antigen
  • Immunization with any other non-study vaccine product within three weeks prior to enrollment in the current study, or refusal to postpone such until the end of the three-week period after completion of the current study
  • Regular use of nasal irrigation therapy during the last six months prior to enrollment in the current study or episodic use of the above method of treatment in the two weeks prior to the screening
  • History of frequent nosebleeds (>5) during the year prior to the current study
  • Features of the nasal anatomy that may complicate intranasal administration of the study drug.
  • Surgical interventions or traumatic injuries in the sinus area, paranasal sinuses, or traumatic injuries of the nose within a month before screening
  • Symptoms of acute respiratory disease, including fever, or other acute illness at the time of screening or within two weeks prior to screening
  • Treatment with immunoglobulins or other blood derived medications in the three months prior to screening or planning such treatment during the period of participation in the current study
  • History of bronchial asthma
  • Hypersensitivity and the presence of severe allergic reactions, including Quincke's edema, anaphylactic shock after the previous administration of any vaccine
  • History of wheezing after previous immunization with live influenza vaccine
  • Other adverse events after immunization (fever above 40°C, syncope, non-febrile convulsions, anaphylaxis) when there is a minimal likelihood that they are associated with a previous administration of any vaccine
  • Suspicion of hypersensitivity to any component of the study vaccine, including egg protein
  • Acute or chronic clinically significant lung, cardiovascular, hepatic, endocrine, neurological, or psychiatric disorders, or impaired renal function identified by history, physical examination, or clinical laboratory findings that, in the opinion of the investigator, may influence the outcome of the study
  • History of oncological diseases
  • History of thrombocytopenic purpura or bleeding disorders
  • History of convulsions
  • Chronic alcohol dependence or chronic use of illicit drugs, drug abuse
  • Claustrophobia and social phobia according to history and / or available medical records
  • Inability to read Russian; inability or unwillingness to understand the essence of the study
  • Military personnel undergoing military service on conscription
  • Special diet (eg, vegetarian, vegan, salt-restricted) or lifestyle (night work, extreme physical activity)
  • Any condition that, in the opinion of the investigator, may increase the risk to the health of a volunteer participating in the study or affect the results of the study

Trial locations and contacts

3 sites in 1 country.

Russia3 sites

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022

  • Smorodintsev Research Institute of Influenza

    Saint Petersburg, 197022

  • St. Petersburg City Polyclinic No. 34

    Saint Petersburg, 197198

Other trials in Russia

About this study

Official title: Randomized, Double-blind, Placebo-controlled Phase 2 Trial of ТВ/Flu-05Е Intranasal Vector Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 Years

The aim of the study is to investigate immunogenicity and safety of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years

Read the detailed description

Study includes 160 participants aged 18 to 50, randomized at 3:1 ratio, to receive single intranasal dose of TB/Flu-05E vaccine or placebo, correspondingly. Duration of the study for each participant is about 4 months (no more than 114 days).

Conditions
Tuberculosis
Being tested
TB/Flu-05E, Placebo
Keywords
Tuberculosis vaccine, BCG boost, influenza vector, mucosal 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-05EBiological

    Participants will receive single intranasal injection of TB/Flu-05E vaccine in 0.5 ml, containing 7.7 lg EID50 of A/H1N1pdm09 recombinant attenuated influenza vector with modified NS gene, encoding for the TB10.4 and HspX antigens of M. tuberculosis

  • PlaceboOther

    Participants will receive single intranasal injection of physiological buffer in 0.5 ml

Study groups in NCT06873282
Study groupRoleWhat they receive
TB/Flu-05EExperimentalSingle dose of TB/Flu-05E vector vaccine
Receives: Biological: TB/Flu-05E
PlaceboPlacebo comparatorSingle dose of Placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of TB antigen-specific cytokine producing T-cells

    Change from baseline in the level of cytokine producing T-cells upon in vitro stimulation of PBMC with M. tuberculosis peptide epitopes (TB10.4, HspX) measured by FACS/ELISPOT

    Measured: Days 1, 7, 21

  2. Level of TB antigen-specific cytokine release in whole blood assay

    Change from the baseline of the cytokine concentration in whole-blood cytokine release assay upon in vitro stimulation with M. tuberculosis peptide epitopes (TB10.4, HspX) measured in ELISA

    Measured: Days 1, 7, 21

Secondary outcomes (7)

  1. Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)

    Adverse events (AEs) and serious AEs (SAEs), both vaccine related, and non-vaccine related. AEs/SAEs of particular importance: - Immediate AEs (allergic reactions) occurring within two hours of vaccination;

    • Post-vaccination reactions (anticipated clinical manifestations of a local and systemic nature), usually due to intranasal vaccination between two hours and the next 7 days after vaccination

    Measured: Throughout the study, average 4 months

  2. Percent of participants with T-cell response to M. tuberculosis antigens

    Relative number of participants with T-cell response to the M. tuberculosis antigens (TB10.4 or HspX) in any of the tests (FACS/ELISPOT, whole blood cytokine release assay) at any of the study days

    Measured: Days 7, 21

  3. Level of TB antigen-specific IgG antibody in serum

    Change from the baseline in the level of TB10.4 and HspX specific IgG antibody measured in ELISA in serum

    Measured: Days 1, 21, 111±3

  4. Level of B-cell and Tfh-cell populations

    Change from the baseline in the relative amount of B-cell and Tfh-cell populations measured by FACS

    Measured: Days 1, 7, 21

  5. Level of mucosal IgA antibody in nasal secret

    Change from the baseline in the level of IgA antibody measured in ELISA in nasal secret

    Measured: Days 1, 21

  6. Level of influenza-specific cytokine producing T-cells

    Change from baseline in the level of cytokine producing T-cells upon in vitro stimulation of PBMC with influenza antigen measured by ICS/ELISPOT

    Measured: Days 1, 7, 21

  7. Influenza specific systemic antibody immune response

    Change from baseline in the titer of influenza specific antibodies in serum measured in hemagglutination inhibition/microneutralization assay

    Measured: Days 1, 21, 111±3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2025
  2. Study start13 Dec 2023
  3. Primary completion12 Jan 2024
  4. Study completion11 Apr 2024

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06873282
Sponsor's protocol ID
ВПТ-2-06/2023
Status last verified
Nov 2023
First submitted
6 Mar 2025
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only IPD used in the results publication will be available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TB/Flu-05E in people with Tuberculosis, run by Research Institute of Influenza, Russia at 3 sites in Russia.

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 23 inclusion and 29 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 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Russia. 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. Some participants in this study may receive a placebo. 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 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?

Level of TB antigen-specific cytokine producing T-cells (time frame: Days 1, 7, 21). 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?

On the ClinicalTrials.gov record for NCT06873282.

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 20 Mar 2025.

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