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

PHASE2CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

December 13, 2023

Primary Completion Date

January 12, 2024

Study Completion Date

April 11, 2024

Conditions
Tuberculosis
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

Trial Locations (3)

197022

Pavlov First Saint Petersburg State Medical University, Saint Petersburg

Smorodintsev Research Institute of Influenza, Saint Petersburg

197198

St. Petersburg City Polyclinic No. 34, Saint Petersburg

All Listed Sponsors
collaborator

Pavlov First Saint Petersburg State Medical University

OTHER

collaborator

St. Petersburg City Polyclinic No. 34

UNKNOWN

lead

Research Institute of Influenza, Russia

OTHER

NCT06873282 - Phase 2 Study of the ТВ/Flu-05Е Tuberculosis Vaccine | Biotech Hunter | Biotech Hunter