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

NCT06873282 | Completed Phase 2 DMC

• 1 other identifier: ВПТ-2-06/2023
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

Brief 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

Tuberculosis

Keywords

Tuberculosis vaccine; BCG boost; influenza vector; mucosal vaccine

Outcome Measures

Primary Outcomes (2)

• Level of TB antigen-specific cytokine producing T-cells

  Change from baseline in the level of cytokine producing T-cells upon in vitro stimulation of PBMC with M. tuberculosis peptide epitopes (TB10.4, HspX) measured by FACS/ELISPOT

  Days 1, 7, 21

• Level of TB antigen-specific cytokine release in whole blood assay

  Change from the baseline of the cytokine concentration in whole-blood cytokine release assay upon in vitro stimulation with M. tuberculosis peptide epitopes (TB10.4, HspX) measured in ELISA

  Days 1, 7, 21

Secondary Outcomes (7)

• Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)

  Throughout the study, average 4 months

• Percent of participants with T-cell response to M. tuberculosis antigens

  Days 7, 21

• Level of TB antigen-specific IgG antibody in serum

  Days 1, 21, 111±3

• Level of B-cell and Tfh-cell populations

  Days 1, 7, 21

• Level of mucosal IgA antibody in nasal secret

  Days 1, 21

Study Arms (2)

TB/Flu-05E

EXPERIMENTAL

Single dose of TB/Flu-05E vector vaccine

Biological: TB/Flu-05E

Placebo

PLACEBO COMPARATOR

Single dose of Placebo

Other: Placebo

Interventions

TB/Flu-05E BIOLOGICAL

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

TB/Flu-05E

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy BCG-vaccinated men and women aged 18 to 50 years
• Availability of signed informed consent
• Diagnosed "healthy" according to the data of standard clinical, laboratory and instrumental examination methods, with the absence of clinically significant changes. Participants with chronic conditions that do not require special treatment, such as diabetes mellitus, hypertension, or heart disease, are eligible to participate in this study if the investigator considers the participant's condition to be medically stable
• The ability and willingness to make entries in the diary of self-observation, as well as to carry out all the visits foreseen in the study for control medical observation
• Consent of study participants to use effective contraceptive methods throughout their participation in the study. In this study, volunteers can use the following methods of contraception:
• Barrier methods:
• male condom and spermicide
• cervical cap and spermicide
• vaginal diaphragm and spermicide
• Intrauterine device
• Hormonal intrauterine device
• Hormonal contraceptives:
• hormonal implants
• hormone injections
• combined oral contraceptives

You may not qualify if:

• Participation in another clinical study within three months prior to the start of the current study; planning to participate in another study during the current study period
• Clinical, radiological or laboratory signs of active or previously transferred tuberculosis of any localization.
• Existence in the past or present of contact with patients with any form of tuberculosis (at home, at work, in the circle of friends and acquaintances)
• Tuberculous infection confirmed by the TB-FERON IGRA laboratory test
• Immunization with BCG within six months prior to enrollment in the current study
• Contact with COVID-19 patients within 14 days prior to the start of the clinical study
• Positive rapid test result for SARS-CoV-2 antigen
• Immunization with any other non-study vaccine product within three weeks prior to enrollment in the current study, or refusal to postpone such until the end of the three-week period after completion of the current study
• Regular use of nasal irrigation therapy during the last six months prior to enrollment in the current study or episodic use of the above method of treatment in the two weeks prior to the screening
• History of frequent nosebleeds (\>5) during the year prior to the current study
• Features of the nasal anatomy that may complicate intranasal administration of the study drug.
• Surgical interventions or traumatic injuries in the sinus area, paranasal sinuses, or traumatic injuries of the nose within a month before screening
• Symptoms of acute respiratory disease, including fever, or other acute illness at the time of screening or within two weeks prior to screening
• Treatment with immunoglobulins or other blood derived medications in the three months prior to screening or planning such treatment during the period of participation in the current study
• History of bronchial asthma

Sponsors & Collaborators

• Research Institute of Influenza, Russia: lead
• Pavlov First Saint Petersburg State Medical University: collaborator
• St. Petersburg City Polyclinic No. 34: collaborator

Study Sites (3)

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, 197022, Russia

Location

Smorodintsev Research Institute of Influenza

Saint Petersburg, 197022, Russia

Location

St. Petersburg City Polyclinic No. 34

Saint Petersburg, 197198, Russia

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Marina Stukova, Dr

  Smorodintsev Research Institute of Influenza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the clinical department

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: December 13, 2023
• Primary Completion: January 12, 2024
• Study Completion: April 11, 2024
• Last Updated: March 20, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Access Criteria: IPD will be available upon reasonable request to Study Director. Once the request is approved, the data can be transferred via a secure online platform

Locations

RU (3)