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TuberculosisPhase 1NCT05398562

Tolerability and Reactogenicity Trial of the Recombinant Tuberculosis Allergen in Healthy Volunteers

A Phase 1 study testing Mycobacterial recombinant allergens 0.1 μg and Mycobacterial recombinant allergens 0.2 μg in people with Tuberculosis and Skin Tests, run by St. Petersburg Research Institute of Vaccines and Sera 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

Primary objective of the trial is to study the safety and tolerability of the Recombinant tuberculosis allergen in standard dilution in healthy volunteers after a single dose. Additional trial purpose: evaluation of the product reactogenicity. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Tuberculosis, Skin Tests
What is being tested?
Mycobacterial recombinant allergens 0.1 μg and Mycobacterial recombinant allergens 0.2 μg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteRussia
Study dates
13 Feb 2020to 26 Jun 2020
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

  • Availability of the volunteer's written consent to participate in the trial according to the existing legislation.
  • Age between 18 and 50 years old, inclusively.
  • Body mass index (BMI) within the range of 18.5 ≤ BMI ≤ 30 kg/m2 with body weight at least 45 kg and not more than 100 kg.
  • Verified "healthy" status: no deviations from reference values of standard clinical, laboratory and instrumental examinations. For female volunteers: negative pregnancy test (for female volunteers with preserved reproductive capacity, i.e. those who are not in menopause and who have not undergone sterilization surgery).
  • Absence of tuberculosis (TB) at chest X-ray or photofluorography
  • Negative result of TB laboratory examination (T-SPOT.TB test, sputum examination for mycobacterium tuberculosis (MBT)).
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  • Negative test for HIV 1 and 2, syphilis (RPR), hepatitis В (HBsAg) and С (HCV RNA) markers.
  • Consent of the volunteer (including a female partner) to use adequate contraception methods throughout the trial and 7 days upon its completion. If hormonal contraceptives are used, they must be canceled at least 2 months before the start of the trial.
  • Hemodynamic and other vital signs should be within normal limits (reference intervals are 60-90 beats/min at rest for heart rate (HR), up to 22 per minute for respiratory rate (RR), body temperature (BT) from 35.5 to 36.9 °C; systolic blood pressure (SBP) is considered normal blood pressure (BP) in the range of 100-130 mmHg, diastolic blood pressure (DBP) is considered normal in the range of 60-89 mmHg).
  • Negative breath alcohol test.
  • Negative urinalysis for abuse of medicinal products (MP) and consumption of narcotic substances (NS), including cocaine, cannabis, amphetamies, barbiturates and opiods.
  • Abstinence from alcohol for 14 days before the start of the trial and until the end of participation in the trial.
  • Abstinence from smoking for 48 hours before the start of the trial and during hospitalization.

Who cannot join

  • Inability to provide an informed consent.
  • History of allergies.
  • Acute or chronic infectious diseases (including flu, ARVI) within 30 days before the start of the trial.
  • History of tuberculosis or known contact of a volunteer and/or their family members with a person infected with TB.
  • Contact with MBT carriers.
  • Symptoms of pulmonary or extrapulmonary TB, respiratory and systemic TB.
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  • Symptoms of mycobacteriosis (chronic productive cough, asthenia, fever, sweating) and/or changes (infiltration with degradation, nodules, tumor like lesions) at chest X-ray/photofluorography during screening or according to the medical history.
  • Congenital or acquired abnormalities of the immune system.
  • A history of diseases affecting lymphoid organs (Hodgkin lymphoma, other lymphomas, leukemias, sarcoidosis).
  • A history of epilepsy.
  • Viral or bacterial infection that may affect cellular immune response during the screening.
  • Generalized skin diseases, including eczema, psoriasis, ichthyosis, burns, rash etc.
  • A condition affecting the blood clotting and causing a risk of hemorrhage.
  • Any immunomodulatory therapy (immunoglobulins, systemic corticosteroids, methotrexate, azathioprine, cyclosporine, infliximab and other blood products) 6 months before the start of the trial.
  • Previous vaccination 6 months before the start of the trial.
  • Consumption of medicinal products that have a significant impact on hemodynamics, liver function etc. (barbiturates, omeprazole, cimetidine etc.), oral anticoagulants, products metabolized by CYP2D6 less than 2 months before the start of the trial.
  • Vital signs outside the reference ranges: SBP less than 100 mmHg or more than 130 mmHg; DBP less than 60 mmHg or more than 89 mmHg; HR less than 60 bpm or more than 90 bpm; BT less than 35.5 or more than 36.9°С, RR more than 22 breaths per minute.
  • Laboratory values outside the reference ranges.
  • TB foci at chest X-ray or photofluorography.
  • Positive result of TB laboratory examination (T-SPOT.TB test, sputum examination for MBT).
  • Tuberculin skin test (Mantoux test) or Diaskintest less than 6 months before the start of the trial.
  • Consumption more than 5 units of alcohol per week (where each unit is equal to 30 mL of strong drinks or 325 mL of beer) and/or a history of alcohol, product, substance abuse and abuse of medicinal products.
  • Smoking more than 10 cigarettes per day and inability to refrain from smoking 48 hours before the start of the trial and during the hospital stay.
  • Special diet (e.g. vegetarian, vegan, with limited salt consumption) or life style (night shifts, extreme physical efforts).
  • Positive breath alcohol test.
  • Positive urinalysis for MP abuse and consumption of narcotic substances (NS), including cocaine, cannabis, amphetamies, barbiturates and opiods.
  • Positive pregnancy test, lactation period (for female volunteers).
  • Donation (450 or more mL of blood) within 30 days before the start of the trial.
  • Participation in any phase of the clinical trial 90 days before the start of the trial.
  • Unavailability for observation throughout the trial, inability to comply with the visit schedule, inability to be hospitalized for a period of up to 5.5 days, high risk of problems that may occur during the central line installation or upper arm vein puncture.
  • Affiliation with the vulnerable group of volunteers (minors; incapable persons; people with limited freedom of expression or people who might be participating in the trial against their will (serving sentences, held in detention, military personnel).
  • Other reasons which, in the investigator's opinion, prevent the volunteer to take part in the trial or create an unjustified risk.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Limited Liability Company "Scientific Research Center Eco-Safety"

    Saint Petersburg

Other trials in Russia

About this study

Official title: Simple Blind, Placebo Controlled, Randomized, Two-stage, Prospective, Single-center Safety, Tolerability and Reactogenicity Trial of the [Recombinant Tuberculosis Allergen in Standard Dilution], Solution for Intradermal Injection, 0.1 mL/Dose, Produced by FSUE SPbSRIVS FMBA of Russia, in Healthy Volunteers After a Single Dose in the Dilution of 0.1 µg / 0.1 mL or 0.2 µg / 0.1 mL

Primary objective of the trial is to study the safety and tolerability of the Recombinant tuberculosis allergen in standard dilution in healthy volunteers after a single dose.

Additional trial purpose: evaluation of the product reactogenicity.

Read the detailed description

The trial product is an Intradermal test to diagnose tuberculosis infection and nontuberculosis mycobacteriosis in combination with other methods. The trial will include 2 stages (stage I, II). At stage I 5 healthy volunteers will be consequently included in each group to evaluate tolerance and reactogenicity. Time required to evaluate the tolerance and reactogenicity for the first 5 volunteers in each group is less than 3 days. If no SAEs which have a "possible", "probable" and "definite" causal relationship with the product administration are observed in more than three volunteers from each group, the remaining volunteers will be allowed to take part in the trial. At stage II 20 healthy volunteers will be included in each group. Each volunteer will be assigned a two-digit randomization number.

Being tested
Mycobacterial recombinant allergens 0.1 μg, Mycobacterial recombinant allergens 0.2 μg, Placebo
Keywords
Tuberculosis, Diagnosis, Recombinant Tuberculosis Allergen, Mycobacterial recombinant allergens, Allergen, SPbSRIVS
Medical subject headings
Tuberculosis, Disease

What participants receive

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

  • Mycobacterial recombinant allergens 0.1 μgDiagnostic test

    Also called Recombinant tuberculosis allergen in standard dilution

    solution for intradermal injection, 0.1 µg / 0.1 mL

  • Mycobacterial recombinant allergens 0.2 μgDiagnostic test

    Also called Recombinant tuberculosis allergen in standard dilution

    solution for intradermal injection, 0.2 µg / 0.1 mL

  • PlaceboDiagnostic test

    solution for intradermal injection

Study groups in NCT05398562
Study groupRoleWhat they receive
RTA / 0.1 μg / 0.1 mLExperimentalat stage I - 5 healthy volunteers; at stage II - 20 healthy volunteers. frequency and route of administration: once, intradermally
Receives: Diagnostic Test: Mycobacterial recombinant allergens 0.1 μg
RTA / 0.2 μg / 0.1 mLExperimentalat stage I - 5 healthy volunteers; at stage II - 20 healthy volunteers. frequency and route of administration: once, intradermally
Receives: Diagnostic Test: Mycobacterial recombinant allergens 0.2 μg
Placebo / 0.1 mLPlacebo comparatorat stage I - 5 healthy volunteers; at stage II - 20 healthy volunteers. frequency and route of administration: once, intradermally
Receives: Diagnostic Test: Placebo

What is being measured

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

  1. Incidence of AEs and SAEs

    Measured: Days 0 - 15

Secondary outcomes (14)

  1. Number of participants with abnormal changes in laboratory parameters - Complete blood count (CBC)

    hemoglobin, red blood cells, hematocrit, thrombocytes, leukocytes, ESR, differential leukocyte count (neutrophils, lymphocytes, eosinophils, monocytes, basophils)

    Measured: Days 0, 1; 72 hours upon the administration, day 15

  2. Number of participants with abnormal changes in laboratory parameters - Biochemical blood test (BBT)

    total protein, creatinine, urea, glucose, total bilirubin, direct bilirubin, ALT, AST, AP, CRP, total LDH, total cholesterol, PTI

    Measured: Days 0, 1; 72 hours upon the administration, day 15

  3. Number of participants with abnormal changes in laboratory parameters - Immunologic blood test (IBT)

    IgA,IgM, IgG and IgE in blood serum

    Measured: Days 0, 1; 72 hours upon the administration, day 15

  4. Number of participants with abnormal Changes in laboratory parameters - Urinalysis (UA)

    color, transparency, pH, specific gravity, nitrites, protein, glucose, ketones, urobilinogen, bilirubin, microscopic examination: erythrocytes, leukocytes, casts, except for hyaline casts, bacteria

    Measured: Days 0, 1; 72 hours upon the administration, day 15

  5. Number of participants with abnormal ECG findings

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1 - V6)

    Measured: Days 0, 1; 72 hours upon the administration, day 15

  6. Number of participants with abnormal changes in physical examination data

    Physical examination includes examination of skin and visible mucous membranes, assessment of musculoskeletal system, lymph node palpation, thyroid palpation, objective examination of organ systems (cardiovascular, respiratory, digestive, urinary systems, ear, nose, throat, auscultation of heart and lungs, abdominal examination (sizes of liver and spleen), examination of kidneys, central nervous system)

    Measured: Days 0, 1; 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 hours after administration, day 15

  7. Number of participants with abnormal changes in the functions of vital organs and vital signs - Heart rate (HR)

    The HR is measured during auscultation of the heart in parallel with determining the pulse rate on the radial artery (or on the carotid artery in case of weak pulsation in the radial artery) for a minute while sitting/lying.

    Measured: Days 0, 1; 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 hours after administration, day 15

  8. Number of participants with abnormal changes in the functions of vital organs and vital signs - Respiratory rate (RR)

    RR is measured for a minute at rest in the seated/supine position, by registering the breathing movements of the chest or abdominal wall, without attracting the volunteer's attention.

    Measured: Days 0, 1; 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 hours after administration, day 15

  9. Number of participants with abnormal changes in the functions of vital organs and vital signs - Blood pressure (BP): Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)

    BP (SBP and DBP) is measured on the brachial artery in the prone position according to the Korotkoff method using a certified instrument to measure BP on the same arm with a cuff of length and width matching the length and circumference of the volunteer's shoulder in accordance with the BP measurement recommendations.

    Measured: Days 0, 1; 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 hours after administration, day 15

  10. Number of participants with abnormal changes in the functions of vital organs and vital signs - Body temperature (BT)

    BT is measured with a mercury or digital thermometer in the armpit for at least 5 minutes.

    Measured: Days 0, 1; 20 min. (00:20), 2, 5, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 hours after administration, day 15

  11. Incidence and severity of immediate hypersensibility reactions in each group according to the four-point scale

    • Pruritus at the site of TP/RP injection;
    • Burning sensation at the site of TP/RP injection.

    The assessment will be carried out according to the four-point scale:

    • 0 - no symptoms;
    • 1 - mild symptoms;
    • 2 - symptoms that significantly disrupt normal daily activities;
    • 3 - symptoms that cancel normal daily activities.

    Measured: 20 minutes, 2, 5, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 hours after the administration, day 15

  12. Proportion of volunteers who have withdrawn from the trial early due to the AE/SAE

    Measured: Days 0 - 15

  13. Incidence of systemic post-injection reactions

    • Fever;
    • Cough;
    • Pharyngitis;
    • Fatigue;
    • Arthralgias;
    • Myalgias;
    • Headache;
    • Diarrhea;
    • Chills. the four-point scale:
    • 0 - no symptoms;
    • 1 - mild symptoms;
    • 2 - symptoms that significantly disrupt normal daily activities;
    • 3 - symptoms that cancel normal daily activities.

    Measured: 20 minutes, 2, 5, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 hours after the administration, day 15

  14. Incidence of local post-injection reactions

    • Hyperemia at the injection site;
    • Soreness;
    • Tumidity;
    • Swelling/infiltrate;
    • Enlarged regional lymph nodes;
    • Mucosal changes, papula, vesicle, erosion. the four-point scale:
    • 0 - no symptoms;
    • 1 - mild symptoms;
    • 2 - symptoms that significantly disrupt normal daily activities;
    • 3 - symptoms that cancel normal daily activities.

    Measured: 20 minutes, 2, 5, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 hours after the administration, day 15

Timeline

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

  1. First posted1 Jun 2022
  2. Study start13 Feb 2020
  3. Primary completion17 Jun 2020
  4. Study completion26 Jun 2020

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05398562
Sponsor's protocol ID
ATR-I-004-2019
Status last verified
May 2022
First submitted
26 May 2022
Last updated
1 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mycobacterial recombinant allergens 0.1 μg and Mycobacterial recombinant allergens 0.2 μg in people with Tuberculosis and Skin Tests, run by St. Petersburg Research Institute of Vaccines and Sera 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 13 inclusion and 32 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 1 Jun 2022. 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?

Incidence of AEs and SAEs (time frame: Days 0 - 15). 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 NCT05398562.

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 1 Jun 2022.

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