NCT05398562

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: St. Petersburg Research Institute of Vaccines and Sera · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Tuberculosis
• Skin Tests

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Mycobacterial recombinant allergens 0.1 μg	solution for intradermal injection, 0.1 µg / 0.1 mL
DIAGNOSTIC_TEST	Mycobacterial recombinant allergens 0.2 μg	solution for intradermal injection, 0.2 µg / 0.1 mL
DIAGNOSTIC_TEST	Placebo	solution for intradermal injection

Timeline

• Start date: 2020-02-13
• Primary completion: 2020-06-17
• Completion: 2020-06-26
• First posted: 2022-06-01
• Last updated: 2022-06-01

Locations

1 site across 1 country: Russia