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

NCT05398562 | Completed Phase 1

• 1 other identifier: ATR-I-004-2019
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 purpose: evaluation of the product reactogenicity.

Conditions

Tuberculosis; Skin Tests

Keywords

Tuberculosis; Diagnosis; Recombinant Tuberculosis Allergen; Mycobacterial recombinant allergens; Allergen; SPbSRIVS

Outcome Measures

Primary Outcomes (1)

• Incidence of AEs and SAEs

  Days 0 - 15

Secondary Outcomes (14)

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

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

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

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

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

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

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

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

• Number of participants with abnormal ECG findings

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

Study Arms (3)

RTA / 0.1 μg / 0.1 mL

EXPERIMENTAL

at stage I - 5 healthy volunteers; at stage II - 20 healthy volunteers. frequency and route of administration: once, intradermally

Diagnostic Test: Mycobacterial recombinant allergens 0.1 μg

RTA / 0.2 μg / 0.1 mL

EXPERIMENTAL

at stage I - 5 healthy volunteers; at stage II - 20 healthy volunteers. frequency and route of administration: once, intradermally

Diagnostic Test: Mycobacterial recombinant allergens 0.2 μg

Placebo / 0.1 mL

PLACEBO COMPARATOR

at stage I - 5 healthy volunteers; at stage II - 20 healthy volunteers. frequency and route of administration: once, intradermally

Diagnostic Test: Placebo

Interventions

Mycobacterial recombinant allergens 0.1 μg DIAGNOSTIC_TEST

solution for intradermal injection, 0.1 µg / 0.1 mL

Also known as: Recombinant tuberculosis allergen in standard dilution

RTA / 0.1 μg / 0.1 mL

Mycobacterial recombinant allergens 0.2 μg DIAGNOSTIC_TEST

solution for intradermal injection, 0.2 µg / 0.1 mL

Also known as: Recombinant tuberculosis allergen in standard dilution

RTA / 0.2 μg / 0.1 mL

Placebo DIAGNOSTIC_TEST

solution for intradermal injection

Placebo / 0.1 mL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Petersburg Research Institute of Vaccines and Sera: lead

Study Sites (1)

Limited Liability Company "Scientific Research Center Eco-Safety"

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Tuberculosis; Disease

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: February 13, 2020
• Primary Completion: June 17, 2020
• Study Completion: June 26, 2020
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

RU (1)