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Tuberculosis InfectionPhase 1NCT05945498

Evaluation of ТВ/Flu-05Е Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 Years

A Phase 1 study testing TB/Flu-05E vaccine in people with Tuberculosis Infection, run by Tatyana Zubkova at 1 site 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 safety, reactogenicity and immunogenicity 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 Infection
What is being tested?
TB/Flu-05E vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
1 siteRussia
Study dates
10 May 2023to 18 Sep 2023
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 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 to use effective contraceptive methods throughout their participation in the study.
  • Body weight ≥ 50 kg
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  • HI antibody titers ≤1:20 to influenza A/H1N1pdm09
  • Negative test for alcohol in exhaled air
  • Consent to use effective contraceptive methods throughout their participation in the study
  • 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

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.
  • Passage in the past or at the present time of examination in anti-tuberculosis medical institutions
  • 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
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  • Contact with COVID-19 patients within 14 days prior to the start of the clinical study
  • 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
  • Clinically significant anatomic pathology or the presence of surgical intervention 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; donation of blood/plasma (450 ml or more) less than 2 months prior to screening
  • The presence or suspicion of the presence of various immunosuppressive or immunodeficiency conditions or continuous use (the drug was prescribed for more than 14 days without a break) of immunosuppressive drugs, immunomodulators for 6 months before the screening (for corticosteroids, ≥0.5 mg/kg per day of prednisone or other corticosteroid equivalent; topical and inhaled steroids).
  • 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
  • Seasonal (in spring or autumn) increased sensitivity to the effects of natural factors
  • 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 leukemia or any other malignant diseases of the blood or solid malignant neoplasms of other organs
  • History of thrombocytopenic purpura or bleeding disorders
  • History of convulsions
  • The presence or suspicion of the presence of various immunosuppressive or immunodeficiency conditions, including HIV infection
  • Tuberculosis or residual changes after tuberculosis according to the anamnesis and / or available medical documentation
  • Chronic alcohol dependence or chronic use of illicit drugs, drug abuse
  • Claustrophobia and social phobia according to history and / or available medical records
  • For women of reproductive age - lactation, pregnancy or suspected pregnancy, early postpartum period
  • Premenopausal women (last menstrual period <1 year prior to signing informed consent) who are not surgically sterile and women who are of reproductive potential but do not use or plan to use valid birth control throughout the study and do not agree to perform a urine pregnancy test while participating in the study
  • Military personnel undergoing military service on conscription
  • Persons in custody in pre-trial detention centers and serving sentences in places of deprivation of liberty
  • 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

1 site in 1 country.

Russia1 site

  • Smorodintsev Research Institute of Influenza

    Saint Petersburg

Other trials in Russia

About this study

Official title: Randomized, Double-blind, Placebo-controlled Phase 1 Trial of ТВ/Flu-05Е Intranasal Vector Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50

The aim of the study is to investigate safety, reactogenicity and immunogenicity 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 include 51 participants in two cohorts. At the first stage, 15 volunteers (Cohort 1), randomized in a 2:1 ratio (10 people in the vaccine group and 5 people in the placebo group) will be included in the study. At the second stage, the following 36 people (Cohort 2) will be included in the study, which will be randomly distributed (randomization) in a ratio of 2: 1 for the vaccine preparation (24 people) and placebo (12 people). Duration of the study for each participant is about 4 months (no more than 122 days).

Being tested
TB/Flu-05E vaccine, Placebo
Keywords
Tuberculosis infection, Vaccine, BCG boost, Influenza vector
Medical subject headings
Latent Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TB/Flu-05E vaccineBiological

    Participants will receive single intranasal injection of A/H1N1pdm09 recombinant attenuated influenza vector (7.7 lg EID50) with modified NS gene coding for the TB10.4 and HspX antigens of M. tuberculosis

  • PlaceboBiological

    Participants will receive single intranasal injection of placebo buffer solution

Study groups in NCT05945498
Study groupRoleWhat they receive
TB/Flu-05E vaccineExperimentalSingle dose of 7.7 lg EID50 vector vaccine
Receives: Biological: TB/Flu-05E vaccine
PlaceboPlacebo comparatorSingle dose of placebo
Receives: Biological: Placebo

What is being measured

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

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

    Number of participants with AEs and SAEs including those of particular interest:

    • immediate AEs (allergic reactions) occurring within 2 h after vaccination;
    • post-vaccination reactions between 2 h and a subsequent 7 days;
    • other AEs including unexpected clinical manifestations of a local and systemic nature occurring on the day of vaccination and the following 7 days;
    • influenza A virus shedding detected by rapid test in nasal swab samples

    Measured: Throughout the study, average of 4 months

Secondary outcomes (9)

  1. Concentration of cytokines in nasal secrets after vaccination

    Change from baseline in the concentration of cytokines in nasal secrets measured in ELISA (pg/ml, 13-plex assay, IFN-α2, TSLP, IL-1α, IL-1β, GM-CSF, IL-11, IL-12p40, IL-12p70, IL-15, IL-18, IL-23, IL-27, IL-33)

    Measured: Days 1, 2, 3

  2. Level of mucosal IgA antibody in nasal secret/saliva

    Titers of IgA antibody measured in ELISA in nasal secret/saliva

    Measured: Days 1, 21

  3. 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 measured by ICS/ELISPOT

    Measured: Days 1, 7, 21

  4. 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 А/H1N1pdm09 influenza measured by ICS/ELISPOT

    Measured: Days 1, 7, 21

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

    Change from baseline in the cytokine concentration in whole-blood cytokine release assay upon in vitro stimulation with M. tuberculosis peptide epitopes measured in ELISA

    Measured: Days 1, 7, 21

  6. Level of А/H1N1pdm09 influenza specific cytokine release in whole blood assay

    Change from baseline in the cytokine concentration in whole-blood cytokine release assay upon in vitro stimulation with А/H1N1pdm09 influenza measured in ELISA

    Measured: Days 1, 7, 21

  7. Level of TB antigen-specific IgG antibody

    Changes in the levels of TB antigen-specific total serum IgG antibodies measured in ELISA in serum

    Measured: Days 1, 21

  8. Influenza specific local antibody immune response

    Change from baseline in the level of influenza specific IgA antibodies in nasal secret/saliva measured in ELISA

    Measured: Days 1, 21

  9. Influenza specific systemic antibody immune response

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

    Measured: Days 1, 21

Timeline

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

  1. First posted14 Jul 2023
  2. Study start10 May 2023
  3. Primary completion16 Jun 2023
  4. Study completion18 Sep 2023

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05945498
Sponsor's protocol ID
ВПТ-II-01/2022
Status last verified
Apr 2024
First submitted
13 Jun 2023
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TB/Flu-05E vaccine in people with Tuberculosis Infection, run by Tatyana Zubkova at 1 site 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 11 inclusion and 35 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 18 Apr 2024. 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 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 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?

Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs) (time frame: Throughout the study, average of 4 months). 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 NCT05945498.

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 18 Apr 2024.

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