Phase of Development

Phase 1

Vaccine Platform

Viral Vector

Candidate Overview

TB/FLU-05E is a mucosal TB vaccine candidate based on recombinant attenuated influenza vector (Flu/THSP) co-expressing truncated NS1 protein NS1(1–124) and a full-length TB10.4 and HspX proteins of M.tb within an NS1 protein open reading frame. Vaccine formulation: Liquid nasal spray.

Sponsor / Lead Developer: Smorodintsev Research Institute of Influenza

Development partner(s): Federal State Unitary Enterprise “Scientific and Production Association for Immunological Preparations “Microgen” of the Ministry of Health of the Russian Federation

Clinical Trial Status: Active Trials

Primary Indication: Prevention of Mtb infection or sustained infection

Other Indication(s): Prevention of TB recurrence

Target Population(s): Adolescents, Adults, and Children

Target Route of Administration: Intranasal

Primary endpoint: Safety

Clinical Trials

Registry NumberNCTNCT05945498
Clinical Trial PhasePhase 1
Clinical Trial SponsorResearch Institute of Influenza
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults