Status:
COMPLETED
Tolerability and Reactogenicity Trial of the Recombinant Tuberculosis Allergen in Healthy Volunteers
Lead Sponsor:
St. Petersburg Research Institute of Vaccines and Sera
Conditions:
Tuberculosis
Skin Tests
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 purpos...
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 sta...
Eligibility Criteria
Inclusion
- 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)).
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
February 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2020
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05398562
Start Date
February 13 2020
End Date
June 26 2020
Last Update
June 1 2022
Active Locations (1)
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1
Limited Liability Company "Scientific Research Center Eco-Safety"
Saint Petersburg, Russia