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

NCT05398562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-06-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • St. Petersburg Research Institute of Vaccines and Sera

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2020-06-17
Completion
2020-06-26

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05398562 on ClinicalTrials.gov