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Phase 2 Study of the ТВ/Flu-05Е Tuberculosis Vaccine

NCT06873282 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-03-20

No results posted yet for this study

Summary

The aim of the study is to investigate immunogenicity and safety of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years

Conditions

Interventions

BIOLOGICAL

TB/Flu-05E

Participants will receive single intranasal injection of TB/Flu-05E vaccine in 0.5 ml, containing 7.7 lg EID50 of A/H1N1pdm09 recombinant attenuated influenza vector with modified NS gene, encoding for the TB10.4 and HspX antigens of M. tuberculosis

OTHER

Placebo

Participants will receive single intranasal injection of physiological buffer in 0.5 ml

Sponsors & Collaborators

  • Pavlov First Saint Petersburg State Medical University

    collaborator OTHER

  • St. Petersburg City Polyclinic No. 34

    collaborator UNKNOWN

  • Research Institute of Influenza, Russia

    lead OTHER

Principal Investigators

  • Marina Stukova, Dr · Smorodintsev Research Institute of Influenza

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-13
Primary Completion
2024-01-12
Completion
2024-04-11

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 NCT06873282 on ClinicalTrials.gov