Evaluation of ТВ/Flu-05Е Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 Years

NCT05945498 | Completed Phase 1 DMC

• 1 other identifier: ВПТ-II-01/2022
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate safety, reactogenicity and immunogenicity 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 Infection

Keywords

Tuberculosis infection; Vaccine; BCG boost; Influenza vector

Outcome Measures

Primary Outcomes (1)

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

  Number of participants with AEs and SAEs including those of particular interest: * immediate AEs (allergic reactions) occurring within 2 h after vaccination; * post-vaccination reactions between 2 h and a subsequent 7 days; * other AEs including unexpected clinical manifestations of a local and systemic nature occurring on the day of vaccination and the following 7 days; * influenza A virus shedding detected by rapid test in nasal swab samples

  Throughout the study, average of 4 months

Secondary Outcomes (9)

• Concentration of cytokines in nasal secrets after vaccination

  Days 1, 2, 3

• Level of mucosal IgA antibody in nasal secret/saliva

  Days 1, 21

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

  Days 1, 7, 21

• Level of influenza specific cytokine producing T-cells

  Days 1, 7, 21

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

  Days 1, 7, 21

Study Arms (2)

TB/Flu-05E vaccine

EXPERIMENTAL

Single dose of 7.7 lg EID50 vector vaccine

Biological: TB/Flu-05E vaccine

Placebo

PLACEBO COMPARATOR

Single dose of placebo

Biological: Placebo

Interventions

TB/Flu-05E vaccine BIOLOGICAL

Participants will receive single intranasal injection of A/H1N1pdm09 recombinant attenuated influenza vector (7.7 lg EID50) with modified NS gene coding for the TB10.4 and HspX antigens of M. tuberculosis

TB/Flu-05E vaccine

Placebo BIOLOGICAL

Participants will receive single intranasal injection of placebo buffer solution

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 to use effective contraceptive methods throughout their participation in the study.
• Body weight ≥ 50 kg
• HI antibody titers ≤1:20 to influenza A/H1N1pdm09
• Negative test for alcohol in exhaled air
• Consent to use effective contraceptive methods throughout their participation in the study
• Values of the complete blood count and biochemical blood analysis (during the screening) within 0.9\*reference range lower limit and 1,1 \* reference range upper limit
• Negative tests for HIV, hepatitis B, hepatitis C, and syphilis

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.
• Passage in the past or at the present time of examination in anti-tuberculosis medical institutions
• 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
• Clinically significant anatomic pathology or the presence of surgical intervention 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; donation of blood/plasma (450 ml or more) less than 2 months prior to screening
• The presence or suspicion of the presence of various immunosuppressive or immunodeficiency conditions or continuous use (the drug was prescribed for more than 14 days without a break) of immunosuppressive drugs, immunomodulators for 6 months before the screening (for corticosteroids, ≥0.5 mg/kg per day of prednisone or other corticosteroid equivalent; topical and inhaled steroids).

Sponsors & Collaborators

• Tatyana Zubkova: lead

Study Sites (1)

Smorodintsev Research Institute of Influenza

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the clinical department

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 14, 2023
• Study Start: May 10, 2023
• Primary Completion: June 16, 2023
• Study Completion: September 18, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)